Dissolution Methods [Link]

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Dissolution Methods
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Drug Name Dosage Form USP Apparatus Speed (RPMs) Medium Volume (

Abacavir Sulfate Tablet II (Paddle) 75 0.1 N HCl 900

Abacavir Sulfate/Dolutegravir Tablet II (Paddle) 85 0.01 M Phosphate Buffer with 900

Sodium/Lamivudine 0.5% sodium dodecyl sulfate
(SDS), pH 6.8

Abacavir Sulfate/Lamivudine Tablet II (Paddle) 75 0.1 N HCl 900

Abacavir Sulfate/Lamivudine Tablet II (Paddle) 75 0.1 N HCl Acid Stag

/Zidovudine Buffer Sta
mL

Abemaciclib Tablet II (Paddle) 75 0.01 N HCl 900

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Drug Name Dosage Form USP Apparatus Speed (RPMs) Medium Volume (

Abiraterone Acetate Tablet II (Paddle) 50 0.25% SLS in 56.5 mM 900

phosphate buffer, pH 4.5

Acalabrutinib Capsule II (Paddle) with 50 0.1 M HCl 900

sinker

Acamprosate Calcium Tablet (Delayed I (Basket) 180 Acid Stage: 0.1 N HCl Buffer Media 1:
Release) Stage: "Citrate-sodium 1.1±0.1; M
hydroxide" buffer pH 6.8 (150 950 mL p
ml of 2N NaOH, 21.014 gm of Media 3:
citric acid and ultra-pure water pH 7.5±0
to 1000 ml) (Method B)

Acarbose Tablet II (Paddle) 75 Water (deaerated) 900

Acetaminophen Suppository II (Paddle) 50 Phosphate buffer, pH 5 900

Acetaminophen Tablet (Extended Refer to USP

Release)

Acetaminophen/Aspirin/Caffeine Tablet Refer to USP

Acetaminophen/Butalbital Tablet II (Paddle) 50 Water (deaerated) 900

Acetaminophen/Butalbital/Caffeine Tablet Refer to USP

Acetaminophen/Butalbital/Caffeine Capsule II (Paddle) 50 Water (deaerated) 1000

/Codeine Phosphate

Acetaminophen/Caffeine Capsule I (Basket) 100 Water 900

/Dihydrocodeine Bitartrate

Acetaminophen/Caffeine Tablet II (Paddle) 50 Water 900

/Dihydrocodeine Bitartrate

Acetaminophen/Hydrocodone Tablet Refer to USP (provide

Bitartrate individual unit data).

Acetaminophen/Oxycodone Tablet Refer to USP

Acetaminophen/Oxycodone HCl Tablet (Extended II (Paddle) with 100 0.1 N HCl 900
Release) sinker

Acetaminophen/Pentazocine HCl Tablet I (Basket) 100 Water (deaerated) 900

Acetaminophen/Propoxyphene HCl Tablet Refer to USP

Acetaminophen/Propoxyphene Tablet Refer to USP

Napsylate

Acetaminophen/Tramadol HCl Tablet II (Paddle) 50 0.1 N HCl 900

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Drug Name Dosage Form USP Apparatus Speed (RPMs) Medium Volume (

Acetazolamide Capsule (Extended II (Paddle) 75 Acetate Buffer, pH 4.5 with 900

Release) 2.2% Tween 20

Acetazolamide Tablet Refer to USP

Acetazolomide Tablet Refer to USP

Acetylcysteine Tablet (Effervescent) Develop a dissolution method

Acitretin Capsule Refer to USP

Acrivastine/Pseudoephedrine HCl Capsule II (Paddle) 50 0.01 N HCl 900

Acyclovir Suspension II (Paddle) 50 0.1 N HCl 900

Acyclovir Capsule Refer to USP

Acyclovir Tablet (Buccal) I (Basket) 60 Phosphate Buffer, pH 6.0 1000

Acyclovir Tablet Refer to USP

Adefovir Dipivoxil Tablet II (Paddle) 50 0.01 N HCl 600

Afatinib Dimaleate Tablet II (Paddle) 75 McIlvaine Buffer pH 4.0 900

Albendazole Tablet Refer to USP

Albendazole Tablet (Chewable) II (Paddle) 50 0.1 N HCl 900

Albuterol Sulfate Tablet (Extended II (Paddle) 50 0.1 N HCl 900

Release)

Albuterol Sulfate Tablet Refer to USP

Alectinib HCl Capsule II (Paddle) with 100 pH 1.2, Simulated Gastric Fluid 900
sinker without pepsin, containing 4 %
Triton X-100
[polyoxyethylene[10]octylphenyl
ether]

Alendronate Sodium Tablet Refer to USP

Alendronate Tablet II (Paddle) For Alendronate: 50; For Alendronate: Deaerated For Alend
Sodium/Cholecalciferol For Cholecalciferol: Water; For Cholecalciferol: 900; For
75 0.3% SDS in USP Water Cholecalc

Alfuzosin HCl Tablet (Extended II (Paddle) 100 0.01 N HCl 900

Release)

Aliskiren Hemifumarate Capsule (pellet) I (Basket) 100 0.01 M HCl (degas) 500

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Drug Name Dosage Form USP Apparatus Speed (RPMs) Medium Volume (

Aliskiren Hemifumarate Tablet I (Basket) 100 0.01 N HCl 500

Aliskiren Hemifumarate/Amlodipine Tablet I (Basket) 100 0.01 N HCl, pH 2.0 500

Besylate

Aliskiren Hemifumarate/Amlodipine Tablet I (Basket) 100 0.01 N HCl 900

Besylate/Hydrochlorothiazide

Aliskiren Tablet I (Basket) 100 0.1 N HCl 900

Hemifumarate/Hydrochlorothiazide

Aliskiren Hemifumarate/Valsartan Tablet I (Basket) 100 Phosphate Buffer, pH 6.8 1000

Allopurinol Tablet Refer to USP

Almotriptan Malate Tablet II (Paddle) 50 0.1 N HCl 900

Alogliptin Benzoate Tablet II (Paddle) 50 0.01 N HCl 900

Alogliptin Benzoate/ Metformin HCl Tablet II (Paddle) 50 0.01 N HCl 900

Alosetron HCl Tablet II (Paddle) 50 (for 1 mg) & 75 Water (deaerated) 500
(for 0.5 mg)

Alprazolam Tablet (Extended I (Basket) 100 1% Phosphate Buffer, pH 6.0 500

Release)

Alprazolam Tablet (Orally II (Paddle) 50 70 mM Potassium Phosphate 500

Disintegrating) Buffer, pH 6.0

Alprazolam Tablet Refer to USP

Altretamine Capsule Refer to USP

Alvimopan Capsule II (Paddle 50 0.1 N HCl 900

Amantadine HCl Tablet II (Paddle) 50 Water (deaerated) 500

Amantadine HCl Capsule Refer to USP

Ambrisentan Tablet II (Paddle) 75 0.05 M Acetate Buffer, pH 5.0 900

Amiloride HCl Tablet Refer to USP

Amiloride HCl/Hydrochlorothiazide Tablet Refer to USP

Aminocaproic Acid Tablet Refer to USP

Aminosalicylic Granule (Delayed II (Paddle) 100 Acid Stage: 0.1 N HCl; Buffer 1000
Release) Stage 2: pH 7.5 Phosphate
Buffer

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Drug Name Dosage Form USP Apparatus Speed (RPMs) Medium Volume (

Amiodarone HCl (Test 1) Tablet II (Paddle) 100 1% SLS in water 1000

Amiodarone HCl (Test 2) Tablet I (Basket) 50 Acetate Buffer, pH 4.0, with 1% 900
Tween 80

Amitriptyline HCl Tablet Refer to USP

Amlodipine Besylate Tablet II (Paddle) 75 0.01 N HCl 500

Amlodipine Besylate Tablet (Orally II (Paddle) 50 0.01 N HCl 500

Disintegrating)

Amlodipine Besylate/Atorvastatin Tablet II (Paddle) 75 Phosphate Buffer, pH 6.8 900

Calcium

Amlodipine Besylate/Benazepril Capsule I (Basket) 100 0.01 N HCl 500

HCl

Amlodipine Tablet II (Paddle) 50 Phosphate Buffer, pH 6.8 900

Besylate/Hydrochlorothiazide
/Olmesartan Medoxomil

Amlodipine Tablet Refer to USP

Besylate/Hydrochlorothiazide
/Valsartan

Amlodipine Besylate/Olmesartan Tablet II (Paddle) 50 Phosphate Buffer, pH 6.8 900

Medoxomil

Amlodipine besylate/Perindopril Tablet II (Teflon coated 75 0.01 N HCL 1000

Arginine paddle)

Amlodipine Besylate/Telmisartan Tablet II (Paddle) 75 Telmisartan: Phosphate Buffer, Telmisart

pH 7.5; Amlodipine: 0.01N HCl, Amlodipin
pH 2

Amlodipine Besylate/Valsartan Tablet Refer to USP

Amoxicillin Tablet (Extended II (Paddle) 100 3 Stage dissolution: 50 mM 900

Release) potassium phosphate
monobasic buffer at pH 4.0 (0-2
hours), 6.0 (2-4 hours) and 6.8
( 4 hours and beyond)

Amoxicillin Capsule Refer to USP

Amoxicillin Tablet Refer to USP

Amoxicillin For Oral Suspension II (Paddle) 50 Water (degassed) 900

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Drug Name Dosage Form USP Apparatus Speed (RPMs) Medium Volume (

Amoxicillin/Clarithromycin Capsule/Tablet Refer to USP for monographs

/Lansoprazole /Capsule (Copackage) of Amoxicillin Capsules,
Clarithromycin Tablets and
Lansoprazole Delayed-Release
Capsules

Amoxicillin/Clarithromycin Capsule/Tablet Refer to USP for monographs

/Omeprazole /Capsule (Copackage) of Amoxicillin Capsules,
Clarithromycin Tablets and
Omeprazole Delayed-Release
Capsules

Amoxicillin/Clavulanate Potassium Tablet Refer to USP As appro

Amoxicillin/Clavulanate Potassium Suspension II (Paddle) 75 Water (deaerated) 900

Amoxicillin/Clavulanate Potassium Tablet (Chewable) Refer to USP

Amphetamine Suspension (Extended Develop a dissolution method

Release)

Amphetamine Tablet (Extended II (Paddle 75 Acid Stage: 0.1 N HCl; Buffer Acid Stag
Release, Orally Stage: Phosphate Buffer, pH Buffer Sta
Disintegrating) 6.8 mL

Amphetamine Tablet I (Basket) 100 Deionized Water 500

Aspartate/Amphetamine
Sulfate/Dextroamphetamine
Saccharate/Dextroamphetamine
Sulfate

Amphetamine Capsule (Extended II (Paddle) 50 Dilute HCl, pH 1.1 for first 2 hrs, 0-2 hrs: 7
Aspartate/Amphetamine Release) then add 200 mL of 200 mM After 2 hr
Sulfate/Dextroamphetamine Phosphate Buffer and adjust to
Saccharate/Dextroamphetamine pH 6.0 for the remainder
Sulfate

Amphetamine Capsule (Extended II (Paddle) 50 Media 1: pH 1.1±0.1, Dilute HCl Media 1:

Aspartate/Amphetamine Release) 2 hours; Media 2: pH 6.0±0.1, Media 2:
Sulfate/Dextroamphetamine Phosphate Buffer 3rd hour, Media 3:
Saccharate/Dextroamphetamine Media 3: pH 7.5±0.1,
Sulfate [12.5, 25, 37.5, 50 mg] Phosphate Buffer for the
remainder

Amphetamine ER Capsule II (Paddle) 50 750 ml of dilute HCl, pH 1.1 for 750 ml of

the first 2 hours, then add 200 200 ml of
ml of 200 mM phosphate buffer, buffer
and adjust to pH 6 (w/ HCl or
NaOH) for the remainder

Amphotericin B Injectable (Liposomal) Develop a method to

characterize in vitro release

Ampicillin/Ampicillin Trihydrate for Oral Suspension II (Paddle) 25 Water (deaerated) 900

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Drug Name Dosage Form USP Apparatus Speed (RPMs) Medium Volume (

Amprenavir Capsule II (Paddle) 50 0.1 N HCl 900

Anagrelide HCl Capsule I (Basket) 100 0.1 N HCl 900

Anastrozole Tablet II (Paddle) 50 Water 900

Apixaban Tablet II (Paddle) 75 0.05 M Sodium Phosphate 900

Buffer with 0.05% SLS, pH 6.8

Apremilast Tablet II (Paddle) 60 0.15% SLS in 25 mM Sodium 900

Phosphate Buffer, pH 6.8

Aprepitant For Oral Suspension II (Paddle) 50 Water (with 1.2% Tween 80) 900

Aprepitant Capsule II (Paddle) 100 2.2% sodium dodecyl sulfate in 900

distilled water

Aripiprazole Tablet (Orally II (Paddle) 75 Acetate Buffer, pH 4.0 1000

Disintegrating)

Aripiprazole For Intramuscular II (Paddle) 50 0.25% Sodium Dodecyl Sulfate 900

Suspension (Extended (SDS) Solution
Release)

Aripiprazole Tablet Refer to USP

Armodafinil Tablet II (Paddle) 50 0.1 N HCl 900

Asenapine Maleate Tablet (Sublingual) II (Paddle) 50 Acetate Buffer, pH 4.5 500

Aspirin Capsule Refer to USP

Aspirin Capsule (Extended II (Paddle) with 100 0.05M Potassium Phosphate 900
Release) sinker Buffer (pH 7.4) with trypsin
(.001%w/v) and sodium azide
(.025% w/v)

Aspirin/ Omeprazole Tablet (Delayed I (Basket) 100 Acid Stage: 0.1 N HCl Acid Stag
Release) (degassed); Buffer Stage: Buffer Sta
Phosphate Buffer, pH 6.8
(degassed)

Aspirin/Butalbital/Caffeine Capsule Refer to USP

Aspirin/Butalbital/Caffeine Tablet Refer to USP

Aspirin/Butalbital/Caffeine/Codeine Capsule Refer to USP

Phosphate

Aspirin/Caffeine/Orphenadrine Tablet I (Basket) 75 Water (deaerated) 900

Citrate

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Drug Name Dosage Form USP Apparatus Speed (RPMs) Medium Volume (

Aspirin/Dipyridamole Capsule I (Basket) 100 0.01 N HCl for first hour, 0.1 M 0-1 hrs: 9
Phosphate Buffer, pH 5.5, 900 mL th
thereafter

Aspirin/Hydrocodone Bitartrate Tablet II (Paddle) 75 Acetate Buffer, pH 4.5 900

Aspirin/Meprobamate Tablet I (Basket) 100 Water (deaerated) 900

Aspirin/Methocarbamol Tablet II (Paddle) 50 Water (deaerated) 900

Aspirin/Oxycodone HCl Tablet Refer to USP

Atazanavir Sulfate Capsule II (Paddle) 50 0.025 N HCl 1000

Atazanavir Sulfate/ Cobicistat Tablet II (Paddle) 75 0.05 M Citrate Buffer (pH 2.8) 1000

Atenolol Tablet Refer to USP

Atenolol/Chlorthalidone Tablet Refer to USP

Atomoxetine HCl Capsule II (Paddle) 50 0.1 N HCl 1000

Atorvastatin Calcium Tablet II (Paddle) 75 0.05 M Phosphate buffer, pH 900

6.8

Atorvastatin Calcium/Ezetimibe Tablet II (Paddle), with 75 Phosphate buffer, pH 6.8 with 900
option to use a 0.2% w/v Tween 80
sinker for 20/10
mg strength

Atovaquone Oral Suspension Develop a dissolution method

Atovaquone Tablet II (Paddle) 50 40% isopropanol buffered to pH 900

8.0 with potassium dihydrogen
phosphate

Atovaquone/Proguanil HCl Tablet II (Paddle) with 50 40% isopropranol buffered to 900

PEAK vessels pH 8.0 with potassium
dihydrogen phosphate

Atropine Sulfate/ Diphenoxylate Tablet Develop dissolution method(s)

HCl to characterize the dissolution
of both components

Auranofin Capsule II (Paddle) 50 Water (deaerated) 900

Avanafil Tablet II (Paddle) 50 Simulated gastric fluid without 900

pepsin.

Axitinib Tablet II (Paddle) 75 0.01 N HCl 900

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Drug Name Dosage Form USP Apparatus Speed (RPMs) Medium Volume (

Azacitidine Injectable Suspension Develop a dissolution method

Azathioprine Tablet Refer to USP

Azilsartan Kamedoxomil Tablet II (Paddle) 50 Phosphate Buffer, pH 7.8 900

(deaerated)

Azilsartan Tablet II (Paddle) 50 Phosphate Buffer, pH 6.8 900

Kamedoxomil/Chlorthalidone containing 1.0% Tween 80,

Azithromycin Tablet Refer to USP

Azithromycin Capsule Refer to USP

Azithromycin Oral Suspension II (Paddle) 50 Phosphate buffer, pH 6.0 900

Azithromycin Suspension (Extended II (Paddle) 50 Phosphate Buffer, pH 6.0 900

Release)

Baclofen Tablet (Orally II (Paddle) 25 50 mM Acetate Buffer, pH 4.5 500 mL (

Disintegrating) 1000 mL

Baclofen Tablet Refer to USP

Balsalazide Disodium Capsule II (Paddle) with 50 pH 6.8 buffer 900

sinker

Balsalazide Disodium Tablet II (Paddle) 100 Water (degassed) 1000

Bedaquiline Fumarate Tablet I (Basket) 150 0.01 N HCl 900

Benazepril HCl Tablet II (Paddle) 50 Water (deaerated) 500

Benazepril HCl/Hydrochlorothiazide Tablet I (Basket) 100 0.1 N HCl 500

Bendroflumethiazide/Nadolol Tablet Refer to USP

Benzonatate Capsule Refer to USP

Benzphetamine HCl Tablet II (Paddle) 50 Water 900

Bepridil HCl Tablet I (Basket) 100 0.1 N HCl 900

Betamethasone Injectable Suspension IV (Flow through Flow @ 8 mL/min 0.05% SLS, pH 3.0 or Develop
Acetate/Betamethasone Sodium cell) an in vitro release method
Phosphate using USP IV (Flow-Through
Cell), and, if applicable,
Apparatus II (Paddle) or any
other appropriate method, for
comparative evaluation by the
Agency

Bethanechol Chloride Tablet Refer to USP

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Drug Name Dosage Form USP Apparatus Speed (RPMs) Medium Volume (

Betrixaban Capsule II (Paddle) with 75 0.01 N HCl, (with addition of 900

sinker pepsin if gelatin crosslinking is
observed)

Bexarotene Capsule II (Paddle) 50 Tier 1 Medium: 0.5% HDTMA in 900

0.05 M phosphate buffer, pH
7.5 Tier 2 Medium: 0.5%
HDTMA in 0.05 M phosphate
buffer, pH 7.5 with 0.05 g/L
pancreatin enzyme

Bicalutamide Tablet II (Paddle) 50 1% SLS in water 1000

Bisacodyl/Polyethylene glycol Tablet (Delayed II (Paddle) 100 Acid stage: 0.1 N HCl: Buffer Acid stag
3350/ Potassium Chloride/Sodium Release), For Solution, stage: 0.05 M Phosphate Buffer sta
Bicarbonate/ Sodium Chloride buffer, pH 6.8, with 0.15% mL
sodium lauryl sulfate (SLS)
[only for Bisacodyl Tablets]

Bismuth Subcitrate Capsule II (Paddle) 75 Tetracycline and Metronidazole: 900

Potassium/Metronidazole 0.1 N HCl; Bismuth Subcitrate
/Tetracycline HCl Potassium: Water

Bisoprolol Fumarate Tablet Refer to USP

Bisoprolol Tablet II (Paddle) 75 0.1 N HCl 900

Fumarate/Hydrochlorothiazide

Boceprevir Capsule II (Paddle) with 50 50 mM phosphate buffer, pH 900

sinker 6.8 with 0.1% sodium dodecyl
sulfate

Bosentan Tablet II (Paddle) 50 1% SLS in water 900

Bosentan Tablet (For II (Paddle) 75 0.1 N HCl with 0.5% sodium 900
Suspension) dodecyl sulfate (SDS), pH 1.1

Bosutinib Monohydrate Tablet II (Paddle) 50 0.1 N HCl 900

Brexpiprazole Tablet II (Paddle) 50 0.05 M Acetate buffer, pH 4.3 900

Brigatinib Tablet II (Paddle) 70 50 mM Potassium Phosphate 900

Buffer, pH 7.2

Brimonidine Tartrate/Brinzolamide Ophthalmic Develop a method to

Suspension characterize in vitro release

Brinzolamide Ophthalmic Develop a method to

Suspension characterize in vitro release

Brivaracetam Tablet II (Paddle 50 Phosphate Buffer, pH 6.4 2.5 and 5

tablets: 5
25, 50, 75
mg tablet

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Drug Name Dosage Form USP Apparatus Speed (RPMs) Medium Volume (

Bromocriptine Mesylate Tablet Refer to USP

Budesonide Tablet (Extended II (Paddle) 100 Acid Stage: 0.1 M HCl Acid Stag
Release) containing 0.5% Macrogol ; Buffer S
Cetostearyl Ether; Buffer Stage: mL
pH 7.2 phosphate buffer
containing 0.5% Macrogol
Cetostearyl Ether.

Budesonide Capsule II (Paddle) with 75 Acid stage: 0.1 N HCl; Buffer Acid stag
sinker stage: Phosphate Buffer, pH Buffer sta
7.5

Bumetanide Tablet Refer to USP

Buprenorphine Film, Transdermal VI 50 0.9% Sodium Chloride at 32°C 600

(Extended Release) (Cylinder) with
adapter, if
needed

Buprenorphine HCl Tablet (Sublingual) I (Basket) 100 Water 500

Buprenorphine HCl Film (Buccal) I (Basket) 100 100 0.05M NaH2PO4.H2O 60

mL round Phosphate Buffer, pH 4.5
bottom vessel

Buprenorphine HCl Implant II (Paddle 50 Water 900

Buprenorphine HCl/Naloxone HCl Tablet (Sublingual) I (Basket) 100 Water 500

Buprenorphine HCl/Naloxone HCl Film (Sublingual) V (Paddle over 100 Acetate Buffer, pH 4.0 (12.5mM 900
Disk) with 56 Sodium acetate trihydrate and
mm, 40 mesh 60mM glacial acetic acid.
stainless steel Adjust the pH with glacial acetic
disk. acid or ammonium hydroxide).

Bupropion HCl Tablet Refer to USP

Bupropion HCl Tablet (Extended Refer to USP

Release)

Bupropion Hydrobromide Tablet (Extended I (Basket) 75 0.1 N HCl 900

Release)

Buspirone Hydrochloride Tablet Refer to USP

Busulfan Tablet II (Paddle) 50 Water (Deaerated) 500

Cabergoline Tablet II (Paddle) 50 0.1 N HCl 500

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Drug Name Dosage Form USP Apparatus Speed (RPMs) Medium Volume (

Cabozantinib S-Malate Tablet II (Paddle 75 0.01 N HCl with 0.375% Triton 900
X-100 (degassed)

Cabozantinib S-Malate Capsule II (Paddle) with 75 0.01 N HCl with 0.5% Triton 900
sinker X-100 (degassed)

Calcifediol Capsule (Extended II (Paddle) with 75 0.5% SDS in 5 mM Sodium 500

Release) sinker Dihydrogenphosphate
Monohydrate, pH 6.8

Calcitriol Capsule Develop a quantitative rupture

test

Calcium Acetate Tablet Refer to USP

Calcium Acetate Capsule II (Paddle) 50 Water 900

Canagliflozin Tablet II (Paddle) 75 0.75 % sodium lauryl sulfate 600

(SLS) in water

Canagliflozin (Can)/ Metformin HCl Tablet (Extended Met: I (Basket, Met: 100: Can:100 Met: Simulated Gastric Fluid Met: 900:
(Met) Release) 40 mesh): Can: [SGF] without enzyme, pH 1.2;
I (Basket, 10 Can: 0.1% (w/v) polysorbate 20
mesh [with in 0.05 M sodium phosphate
option of tablet buffer pH 6.8 ( 50 mg); 0.2%
holder]) (w/v) polysorbate 20 in 0.05 M
sodium phosphate buffer pH
6.8 (150 mg)

Canagliflozin/Metformin HCl Tablet II (Paddle) Canagliflozin: 75; Canagliflozin (50 mg): 0.025 % Canagliflo
Metformin: 50 Polysorbate 20; Canagliflozin mg): 900
(150 mg):0.075 % Polysorbate Canagliflo
20; Metformin: Phosphate mg): 900
buffer, pH 6.8 Metformin

Candesartan Cilexetil (16 mg, 8 mg Tablet II (Paddle) 50 0.35% Polysorbate 20 in 0.05 900
and 4 mg) M Phosphate Buffer, pH 6.5

Candesartan Cilexetil (32 mg) Tablet II (Paddle) 50 0.70% Polysorbate 20 in 0.05 900
M Phosphate Buffer, pH 6.5

Candesartan Tablet II (Paddle) 50 0.35% Polysorbate 20 in 900

Cilexetil/Hydrochlorothiazide phosphate buffer pH 6.5
(16/12.5 mg)

Candesartan Tablet II (Paddle) 50 0.70% Polysorbate 20 in 900

Cilexetil/Hydrochlorothiazide phosphate buffer pH 6.5
(32/12.5 mg and 32/25 mg)

Capecitabine Tablet Refer to USP

Captopril Tablet Refer to USP

Carbamazepine Suspension II (Paddle) 50 Water (deaerated) 900

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Drug Name Dosage Form USP Apparatus Speed (RPMs) Medium Volume (

Carbamazepine Tablet (Extended Refer to USP

Release)

Carbamazepine Capsule (Extended II (Paddle) 75 First 4 hours: Dilute Acid, pH First 4 h:

Release) 1.1. After 4 hours: Phosphate 4 h: 900
Buffer, pH 7.5 with 0.1%
sodium lauryl sulfate (SLS).

Carbamazepine Tablet Refer to USP

Carbamazepine Tablet (Chewable) II (Paddle 75 1% SLS in Water 900

Carbidopa Tablet I (Basket) 50 0.1 N HCl 750

Carbidopa/Entacapone/Levodopa Tablet I (Basket) Carbidopa and For both Carbidopa and Carbidop
Levodopa: 50; Levodopa: 0.1 N HCl, For Levodopa
Entacapone: 125 Entacapone: Phosphate buffer Entacapo
pH 5.5

Carbidopa/Levodopa Tablet (Extended II (Paddle) 50 0.1 N HCl 900

Release)

Carbidopa/Levodopa Tablet Refer to USP

Carbidopa/Levodopa Suspension (Enteral) II (Paddle) 25 0.05 M Sodium Acetate Buffer, 500

pH 4.5

Carbidopa/Levodopa Tablet (Orally II (Paddle) 50 0.1 N HCl 750

Disintegrating)

Carbidopa/Levodopa Capsule (Extended I (Basket) 75 Acid stage: Simulated Gastric Acid stag
Release) Fluid [SGF] without enzyme; [for 23.75
Buffer stage: pH 7.0, 50 mM strength],
Phosphate Buffer [other str
Buffer sta
[for 23.75
strength],
[other str

Carbinoxamine Maleate Suspension (Extended II (Paddle) 50 0.4 M Phosphate Buffer 900 [ 895
Release) Buffer +5
Suspensi

Carglumic Acid Tablet II (Paddle) 100 0.05M Phosphate Buffer, pH 750

6.8

Cariprazine HCl Capsule I (Basket) 100 Sodium Acetate Buffer, pH 5.0 500
(degas)

Carisoprodol Tablet Refer to USP

Carvedilol Tablet II (Paddle) 50 SGF without enzyme 900

Carvedilol Tablet Refer to USP

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Drug Name Dosage Form USP Apparatus Speed (RPMs) Medium Volume (

Carvedilol Phosphate Capsule (Extended II (Paddle) 100 0.1 N HCl 900

Release)

Carvedilol Phosphate Capsule (Extended II (Paddle) 100 0.1 N HCl 900

Release)

Cefaclor Capsule Refer to USP

Cefaclor Tablet (Chewable) Refer to USP

Cefaclor Tablet (Extended Refer to USP

Release)

Cefadroxil Tablet Refer to USP

Cefadroxil Capsule Refer to USP

Cefadroxil Suspension II (Paddle) 25 Water 900

Cefdinir Capsule II (Paddle) 50 Phosphate Buffer, pH 6.8 900

Cefdinir Suspension II (Paddle) 50 0.05 M Phosphate buffer, pH 900

6.8

Cefditoren Pivoxil Tablet II (Paddle) 75 Simulated Gastric Fluid without 900

enzyme

Cefixime Suspension II (Paddle) 50 0.05 M Phosphate buffer, pH 900

7.2

Cefixime Capsule I (Basket) 100 0.05 M Phosphate Buffer, pH 900

7.2

Cefixime Tablet Refer to USP

Cefixime Tablet (Chewable) II (Paddle 25 Phosphate Buffer, pH 7.2 900

Cefpodoxime Proxetil Suspension II (Paddle) 50 Glycine Buffer (0.04 M) pH 3.0 900

Cefpodoxime Proxetil Tablet Refer to USP

Cefprozil Tablet Refer to USP

Cefprozil Tablet Refer to USP

Cefprozil For Oral Suspension II (Paddle) 25 Water 900

Cefprozil Monohydrate Suspension II (Paddle) 25 Water (deaerated) 900

Ceftibuten Dihydrate Suspension II (Paddle) 50 0.05 M Phosphate Buffer, pH 1000

7.0

Cefuroxime Axetil Tablet Refer to USP

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Drug Name Dosage Form USP Apparatus Speed (RPMs) Medium Volume (

Celecoxib Capsule II (Paddle) 50 mg, 100 mg and Tier 1 Medium: 0.04 M tribasic Tier 1: 10
200 mg: 50 rpm; sodium phosphate (pH 12) with 2: 750 mL
400 mg: 75 rpm 1% SLS. Tier 2 Initial Medium: 1000 mL
750 mL of simulated gastric
fluid, USP (includes pepsin); At
20 minutes, while stirring, add
180 mL of appropriate
concentrations of SLS solution
(for a final concentration of 1%
SLS). Add about 70 mL of 1.2
N NaOH to adjust the pH to 12.

Cephalexin Suspension II (Paddle) 25 Water 900

Cephalexin Capsule Refer to USP

Ceritinib Capsule II (Paddle) 60 0.01 M HCl (degassed) 900

Cetirizine Capsule (Soft-Gelatin) II (Paddle) 50 25 mM pH 6.8 phosphate buffer 900

Cetirizine HCl Tablet (Regular & II (Paddle) 50 Water (deaerated) 900

Chewable)

Cetirizine HCl Tablet (Orally Refer to USP

Disintegrating)

Cetirizine HCl/Pseudoephedrine Tablet (Extended I (Basket) 100 0.1 N HCl 500

HCl Release)

Cevimeline HCL Capsule II (Paddle) with 50 0.1 N HCl 900

option to use a
sinker

Chlorambucil Tablet II (Paddle) 75 0.1 N HCl 900

Chlordiazepoxide HCl/ Clidinium Capsule Refer to USP (provide

Bromide individual unit data).

Chlorothiazide Suspension Develop a dissolution method

Chlorpheniramine Maleate Tablet (Extended III 27 dpm Row 1: Test Fluid 1 (0.1N HCl) Row 1: 2
Release) (Reciprocating for 1st hour. Row 2: Test fluid 2 Row 2: 2
Cylinder) (Phosphate Buffer, pH 7.5) for
5th hour

Chlorpheniramine Maleate/Codeine Tablet (Extended II (Paddle) 50 Simulated gastric fluid (SGF) 900
Phosphate Release) without enzyme (pH 1.2)

Chlorpheniramine Tablet II (Paddle) 50 50 mM Potassium Phosphate 900

Maleate/Ibuprofen/Phenylephrine Buffer, pH 6.5 (degassed)
HCl

Chlorpheniramine Tablet II (Paddle) 50 0.05 M Phosphate Buffer, pH 900

Maleate/Ibuprofen 6.5
/Pseudoephedrine HCl

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Drug Name Dosage Form USP Apparatus Speed (RPMs) Medium Volume (

Chlorpheniramine Polistirex/ Suspension (Extended II (Paddle) 50 Acid Stage: 0.1 N HCl; Buffer Acid Stag
Codeine polistirex Release) Stage: pH 6.8 Phosphate Buffer Buffer Sta
[500 mL 0.1 N HCl for 1 hour, mL
followed by addition of 400 mL
of 0.2M NaH2P04 to pH 6.8]

Chlorpheniramine Capsule (Extended II (Paddle) 50 Simulated Intestinal Fluid 500

Polistirex/Hydrocodone Polistirex Release) without enzyme

Chlorpheniramine Extended Release Oral II (Paddle) 50 Simulated Gastric Fluid (SGF) 495
Polistirex/Hydrocodone Polistirex Suspension at 37ºC ± 0.5ºC

Chlorpromazine HCl Tablet Refer to USP

Chlorthalidone Tablet Refer to USP

Chlorzoxazone Tablet Refer to USP

Cholic Acid Capsule II (Paddle) with 100 Phosphate Buffer, pH 6.8 500 mL fo
sinker capsule;
250 mg c

Choline Fenofibrate Capsule (Delayed II (Paddle) 50 Acid Stage: 0.05M Sodium Acid stag
Release) Phosphate, pH 3.5 ± 0.05; Buffer sta
Buffer Stage: 0.05 M Sodium
Phosphate, pH 6.8 ± 0.05

Ciclopirox Topical Suspension Develop a method to

characterize in vitro release

Cilostazol Tablet II (Paddle) 75 0.3% SLS in water 900

Cinacalcet HCl Tablet II (Paddle) 75 0.05 N HCl 900

Ciprofloxacin Oral Suspension II (Paddle) 100 0.05 M Acetate Buffer with 900
0.025% Brij35 (polyoxyethylene
lauryl ether), pH 4.5

Ciprofloxacin Injectable Suspension IV (Flow through Flow @ 6 mL/min 50 mM Acetate Buffer, pH 4.5 480
[Otic] cell-closed loop) @37°C ± 0.5 [use glass beads;
/ 22 mm sample volume: 100 µl]

Ciprofloxacin HCl Tablet (Extended I (Basket) 100 0.1 N HCl 900

Release)

Ciprofloxacin HCl Tablet Refer to USP

Ciprofloxacin HCl/Hydrocortisone Otic Suspension Develop a method to

characterize in vitro release

Ciprofloxacin/Ciprofloxacin HCl Tablet (Extended II (Paddle) 50 0.1 N HCl 900

(AB) Release)

Ciprofloxacin/Dexamethasone Otic Suspension Develop a method to

characterize in vitro release

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Drug Name Dosage Form USP Apparatus Speed (RPMs) Medium Volume (

Citalopram HBr Tablet Refer to USP

Citalopram Hydrobromide Capsule II (Paddle) 50 0.1 N HCl 900

Clarithromycin Tablet (Extended Refer to USP

Release)

Clarithromycin Suspension II (Paddle) 50 0.05 M Phosphate Buffer, pH 900

6.8

Clarithromycin Tablet Refer to USP

Clindamycin HCl Capsule Refer to USP

Clobazam Tablet II (Paddle) 75 0.1 N HCl (degassed) 900

Clobazam Oral Suspension II (Paddle) 75 0.1 N HCl (degassed) 900

Clomiphene Citrate Tablet Refer to USP

Clomipramine HCl Capsule Refer to USP

Clonazepam Tablet Refer to USP

Clonazepam Tablet (Orally II (Paddle) 50 Water 900

Disintegrating)

Clonidine Transdermal Refer to USP

Clonidine ( 0.1 mg) Tablet (Extended II (Paddle) with 50 Acid stage: 0.01 N HCl; Buffer Acid stag
Release) sinker stage: Phosphate Buffer, pH Buffer sta
7.0

Clonidine ( EQ. 0.17 mg and EQ. Tablet (Extended II (Paddle) 50 500 mL 0.1N HCl for the 1st Acid stag
0.26 mg) Release) hour, then add 400 mL 0.27M Buffer sta
Sodium Phosphate (Dibasic)
buffer solution

Clonidine HCl Tablet Refer to USP

Clonidine HCl (0.1 mg & 0.2 mg) Tablet (Extended II (Paddle) with 50 Acid stage: 0.01 N HCl; Buffer Acid stag
Release) sinker stage: Phosphate Buffer, pH Buffer sta
7.0

Clopidogrel Bisulfate Tablet Refer to USP

Clorazepate Dipotassium Tablet Refer to USP

Clotrimazole Tablet (Vaginal) II (Paddle) 50 0.1 N HCl 900

Clotrimazole Lozenge Refer to USP

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Drug Name Dosage Form USP Apparatus Speed (RPMs) Medium Volume (

Clozapine Suspension II (Paddle) 50 Acetate Buffer (pH 4.0) 900

Clozapine Tablet Refer to USP

Clozapine Tablet (Orally II (Paddle 50 RPM (12.5 mg, pH 4.5 Acetate Buffer 900
Disintegrating) 25 mg and 100 mg);
75 RPM (150 mg
and 200 mg)

Cobicistat Tablet II (Paddle) 75 50 mM Sodium Acetate Buffer, 900

pH 4.5

Cobicistat (Cobi)/ Darunavir Tablet Cobi: II Cobi: 75; Drv:75 Cobi: 0.05 M Citrate Phosphate Cobi: 900
Ethanolate (Drv) (Paddle): Drv: II Buffer, pH 4.2; Drv: 0.05 M 900 mL
(Paddle) Sodium Phosphate Buffer, pH
3.0, 2% Tween 20

Cobicistat/Elvitegravir/ Tablet II (Paddle) 100 0.05 M sodium citrate buffer pH 1000

Emtricitabine/Tenofovir 5.5 containing 2.0% w/v
Alafenamide Fumarate polysorbate 80

Cobicistat/Elvitegravir/Emtricitabine Tablet II (Paddle) with 100 0.01 N HCl with 2% w/w 1000
/Tenofovir Disoproxil Fumarate sinker Polysorbate 80

Cobimetinib Fumarate Tablet II (Paddle) 50 50 mM Acetate Buffer, pH 4.5 900

Codeine Sulfate Tablet Refer to USP

Colchicine Capsule II (Paddle) 75 Deionized Water with 2% 500

Sodium Lauryl Sulfate (SLS)

Colchicine Tablet Refer to USP

Colesevelam HCl Tablet Disintegration Testing as per

USP <701> in various media
such as deionized water,
simulated gastric fluid and
simulated intestinal fluid.

Crizotinib Capsule I (Basket) 100 0.1N HCl (degassed) 900

Crofelemer Tablet (Delayed II (Paddle) 75 Acid stage: 0.1 N HCl; Buffer Acid stag
Release) stage: Sodium phosphate Buffer sta
buffer, pH 6.8

Cyclobenzaprine Capsule (Extended Refer to USP

Release)

Cyclobenzaprine HCl Tablet Refer to USP

Cyclophosphamide Tablet I (Basket) 100 Water (deaerated) 900

Cycloserine Capsule Refer to USP

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Drug Name Dosage Form USP Apparatus Speed (RPMs) Medium Volume (

Cyclosporine Capsule Refer to USP

Cyclosporine (100 mg) (AB1) Capsule (Liquid filled) II (Paddle) 75 0.1 N HCl containing 4 mg of 1000
N,N-dimethydodecylamine-
N-oxide per mL

Cyproheptadine HCl Tablet Refer to USP

Cysteamine Bitartrate Capsule I (Basket) 75 0.1 N HCl 900

Cysteamine Bitartrate Capsule (Delayed I (Basket) 75 Acid stage: 0.1N HCl; Buffer Acid stag
Release) stage: 0.05 M Sodium Buffer sta
Phosphate buffer, pH 6.8

Dabigatran Etexilate Mesylate Capsule I (Basket) for 75 100 0.01 N HCl (pH 2.0) 900
strength: I
(Basket with
modified
diameter of 24.5
mm) for 150 mg
strength:

Dabrafenib Mesylate Capsule II (Paddle) 65 0.2% Cetyl trimethylammonium 900

bromide (CTAB) in 0.1N HCl

Daclatasvir Dihydrochloride Tablet II (Paddle) 75 Phosphate Buffer, pH 6.8 with 1000

0.75% Brij 35

Dalfampridine Tablet (Extended II (Paddle) 50 Phosphate Buffer, pH 6.8 900

Release)

Danazol Capsule Refer to USP

Dantrolene Sodium For suspension II (Paddle) 50 0.5% Benzalkonium Chloride in 900

(Intravenous ) water

Dantrolene Sodium Capsule I (Basket) 100 0.5% Hyamine 10X in water, 900
adjust to pH 6.8 with 0.1 N
KOH or 0.1 N HCl

Dapagliflozin Propanediol Tablet II (Paddle) 60 Acetate Buffer, pH 4.5 1000

Dapagliflozin Propanediol/ Tablet (Extended I (Basket- 20 100 Phosphate Buffer, pH 6.8 1000
Metformin HCl Release) mesh)

Dapsone Gel (Topical) Develop a method to

characterize in vitro release

Dapsone Tablet Refer to USP

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Drug Name Dosage Form USP Apparatus Speed (RPMs) Medium Volume (

Darifenacin Hydrobromide Tablet (Extended I (Basket) 100 0.01N HCl Comparative 900
Release) dissolution data should also be
provided in 900 ml pH 4.5
buffer, pH 6.8 buffer, and water
using Apparatus I (Basket) at
100 RPM.

Darunavir Ethanolate Oral Suspension II (Paddle) 75 0.05% Polysorbate 20 in 0.05M 900

Phosphate Buffer, pH 6.8

Darunavir Ethanolate Tablet II (Paddle) 75 2% Tween-20 in 0.05 M 900

Sodium Phosphate Buffer, pH
3.0

Dasabuvir Na/ Tablet (Extended III 25 dpm 15 mM 250

Ombitasvir/Paritaprevir/Ritonavir Release) (Reciprocating hexadecyltrimethylammonium
Cylinder [40 bromide (CTAB) in 0.03M
mesh (for Sodium Phosphate Buffer, pH
bottom and top 6.8
of the inner
tube)]

Dasatinib Tablet II (Paddle) 60 pH 4.0 Acetate buffer 1000

containing 1% Triton X-100

Deferasirox Tablet (for Oral II (Paddle) 50 Phosphate buffer pH 6.8 with 900
Suspension) 0.5% Tween 20

Deferasirox Tablet II (Paddle) 75 0.5% Tween 20 in Phosphate 900

Buffer, pH 6.8

Deferasirox Granule II (Paddle) 75 Phosphate Buffer, pH 6.8 with 900

0.5% Tween 20

Deferiprone Tablet II (Paddle) 50 0.1 N HCl 1000

Delafloxacin Meglumine Tablet II (Paddle) 60 0.05 M Phosphate Buffer, pH 900

7.4 (degassed)

Delavirdine Mesylate Tablet II (Paddle) 50 0.05 M Phosphate Buffer, pH 900

6.0 containing 0.6% w/v SDS

Demeclocycline HCl Tablet Refer to USP

Demeclocycline HCl Capsule Refer to USP

Desipramine HCl Tablet Refer to USP

Desloratadine Tablet II (Paddle) 50 0.1 N HCl 500

Desloratadine Tablet (Orally II (Paddle) 50 0.1 N HCl 900

Disintegrating)

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Drug Name Dosage Form USP Apparatus Speed (RPMs) Medium Volume (

Desloratadine/Pseudoephedrine Tablet (Extended II (Paddle) 50 First hour: 0.1 N HCl; After 1 1000
Sulfate (2.5 mg/120 mg) Release) hour: 0.1M Potassium
Phosphate Buffer pH 7.5

Desloratadine/Pseudoephedrine Tablet (Extended II (Paddle) 50 First hour: 0.1 N HCl; After 1 1000
Sulfate (5 mg/240 mg) Release) hour: 0.1M Potassium
Phosphate Buffer pH 7.5

Desmopressin Acetate Tablet II (Paddle) 75 Water (deaerated) 500

Desogestrel/Ethinyl Estradiol Tablet Refer to USP

Desvenlafaxine Succinate Tablet (Extended I (Basket) 100 0.9% NaCl in water 900
Release)

Deutetrabenazine Tablet II (Paddle) over 75 pH 3.0 Acid Phthalate Buffer 500

a disk (62 mm
with 16 mesh)

Dexamethasone Tablet Refer to USP

Dexamethasone Implant (Intravitreal) VII (with 30 cycles per min Phosphate Buffered Saline 30
reciprocating 50 containing 0.05 g/L sodium
mesh baskets) dodecyl sulfate at 45 ± 0.5°C

Dexamethasone/Neomycin Sulfate/ Ophthalmic Develop a method to

Polymyxin B Sulfate Suspension characterize in vitro release

Dexamethasone/Tobramycin Ophthalmic Develop a method to

Suspension characterize in vitro release

Dexbrompheniramine Tablet (Extended III 12 dpm 0.02N HCl (2 hours) followed 250
Maleate/Pseudoephedrine Sulfate Release) (Reciprocating by 0.05M Phosphate Buffer pH
Cylinder) 7.5

Dexlansoprazole Capsule (Delayed I (Basket) 100 Acid Stage: 0.1 N HCl, Buffer Acid Stag
Release) Stage: pH 7.0 Phosphate Buffer Buffer sta
with 5 mM SLS

Dexlansoprazole Tablet (Delayed I (Basket -100 100 Acid Stage: 0.1 N HCl; Buffer Acid Stag
Release, Orally mesh) Stage: pH 7.2 Phosphate Buffer Buffer Sta
Disintegrating) with 5 mM Sodium lauryl sulfate mL

Dexmethylphenidate HCl Tablet I (Basket) 100 Water 900

Dexmethylphenidate HCl Capsule (Extended I (Basket) 100 First 2 hours: 0.01 N HCl, Acid: 500
Release) Hours 2-10: Phosphate Buffer, 500
pH 6.8

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Drug Name Dosage Form USP Apparatus Speed (RPMs) Medium Volume (

Dextroamphetamine Sulfate Tablet I (Basket) 100 Water 500

Dextroamphetamine Sulfate Capsule (Extended I ( Basket) 100 0.1 N HCl 500

Release)

Dextromethophan HBr/Guaifenesin Tablet (Extended I (Basket) 50 0.01 N HCl 900

Release)

Dextromethorphan Capsule I (Basket) 100 pH 1.2, Simulated Gastric Fluid 900

Hydrobromide/Quinidine Sulfate without enzyme

Dextromethorphan Polistirex Suspension (Extended II (Paddle) 50 0.1 N HCl 500

Release)

Diazepam Gel (Rectal) II (Paddle) 50 0.05 M Phosphate Buffer, pH 500

6.8

Diazepam Tablet Refer to USP

Diazoxide Oral suspension Develop a dissolution method

Diclofenac Capsule I (Basket) 100 10 mM Citrate Buffer pH 5.5 900

with 0.05% Sodium Dodecyl
Sulfate (SDS)

Diclofenac Epolamine Topical patch V (Paddle over 50 pH 6.8 phosphate buffer at 32 ± 500
Disk) with a 0.5°C
watchdish (a
diameter of 6
cm)

Diclofenac Potassium Powder for II (Paddle 75 0.05M phosphate buffer 400

Oral Solution (TriSodium Phosphate
Dodecahydrate in 0.1 N HCl
and pH adjusted to 6.8)

Diclofenac Potassium Capsule II (Paddle 50 50 mM Phosphate buffer pH 900

6.8

Diclofenac Potassium Tablet II (Paddle) 50 SIF without enzyme 900

Diclofenac Sodium Tablet (Extended Refer to USP

Release)

Diclofenac Sodium Tablet (Delayed Refer to USP

Release)

Diclofenac Sodium/Misoprostol Tablet (Delayed II (Paddle) 100 (diclo) 50 (miso) Diclofenac: Acid Stage: 0.1 N Diclo: Ac
Enteric Coated Release) (diclo) II HCl Buffer Stage: 750ml 0.1N Buffer:10
(Paddle) (miso) HCL+250ml 0.2M [Link], 500
pH 6.8 (Method A) Misoprostol:
Water (deaerated)

Dicloxacillin Sodium Capsule Refer to USP

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Dissolution Methods [Link]

Drug Name Dosage Form USP Apparatus Speed (RPMs) Medium Volume (

Didanosine Tablet (Chewable) II (Paddle) 75 Water (deaerated) 900

Didanosine Capsule (Delayed I (Basket) 100 Acid stage: 0.1 N HCl; Buffer 1000
Release Pellets) stage: 0.1 N HCl:0.2M Tribasic
Sodium Phosphate (3:1), pH
6.8

Dienogest/Estradiol Valerate Tablet II (Paddle) 50 0.4% SLS in water 900

Diethylpropion HCl Tablet (Extended I (Basket) 100 Water (deaerated) 900

Release)

Diflunisal Tablet Refer to USP

Digoxin Tablet Refer to USP

Diltiazem HCl Tablet (Extended II (Paddle) 100 Phosphate Buffer, pH 5.8 900
Release)

Diltiazem HCl (AB2) Capsule (Extended Refer to USP

Release)

Diltiazem HCl (AB3) Capsule (Extended Refer to USP

Release)

Diltiazem HCl (AB4) Capsule (Extended Refer to USP

Release)

Dimethyl Fumarate Capsule (Delayed II (Paddle) 100 Acid stage: 0.1 N HCl; Buffer Acid stag
Release) stage: pH 6.8 Phosphate Buffer Buffer sta

Dinoprostone Vaginal Suppository Develop a method to

characterize in vitro release

Dinoprostone Vaginal Insert II (Paddle) 50 Deionized Water 500

(Extended Release)

Diphenhydramine Citrate/Ibuprofen Tablet II (Paddle) 50 50 mM Phosphate Buffer, pH 900

6.5

Diphenhydramine HCl/Ibuprofen Capsule I (Basket) 100 200 mM Phosphate Buffer, pH 900

7.2

Dipyridamole Tablet Refer to USP

Disopyramide Phosphate Capsule (Extended Refer to USP

Release)

Disopyramide Phosphate Capsule Refer to USP

Disulfiram Tablet II (Paddle) 100 2% SDS 900

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Drug Name Dosage Form USP Apparatus Speed (RPMs) Medium Volume (

Divalproex Sodium Tablet (Extended Refer to USP

Release)

Divalproex Sodium Capsule (Delayed Refer to USP

Release)

Divalproex Sodium Tablet (Delayed Refer to USP

Release)

Dofetilide Capsule I (Basket) 100 0.001 M HCL 900

Dolasetron Mesylate Tablet Refer to USP

Dolutegravir Na/Rilpivirine HCl Tablet II (Paddle) 75 1.0 % Tween 20 in 0.01 M HCl, 900
pH 2.0

Dolutegravir Sodium (10 mg) Tablet II (Paddle) 50 0.01M pH 6.8 phosphate buffer 900

Dolutegravir Sodium (25 mg) Tablet II (Paddle) 50 0.01M pH 6.8 phosphate buffer 900
containing 0.15% w/v sodium
dodecyl sulfate (SDS)

Dolutegravir Sodium (50 mg) Tablet II (Paddle) 50 0.01M pH 6.8 phosphate buffer 900
containing 0.25% w/v sodium
dodecyl sulfate (SDS)

Donepezil HCl/Memantine HCl Capsule (Extended I (Basket) 100 pH 1.2 NaCl/HCl buffer 900
Release)

Donepezil HCl Tablet (Orally II (Paddle) 50 0.1 N HCl 900

Disintegrating (ODT))

Donepezil HCl Tablet Refer to USP

Donepezil HCl (23 mg) Tablet II (Paddle 50 0.05 M Phosphate Buffer, pH 900
6.8

Doxazosin Mesylate Tablet II (Paddle) 50 0.01 N HCl 900

Doxazosin Mesylate Tablet (Extended II (Paddle) 75 SGF without enzyme 900

Release)

Doxepin HCl Tablet II (Paddle) 50 Simulated Gastric Fluid w/o 900

enzyme (pH 1.1-1.3)

Doxepin HCl Capsule Refer to USP

Doxercalciferol Capsule Develop a quantitative rupture

test

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Drug Name Dosage Form USP Apparatus Speed (RPMs) Medium Volume (

Doxorubicin HCl Injectable (Liposomal) Develop a method to

characterize in vitro release,
starting at pH 6.00 ± 0.05 and
at 47ºC ± 0.5ºC. Replicate for
12 dosage vials.

Doxycycline Suspension II (Paddle) 25 0.01 N HCl 900

Doxycycline Capsule (Delayed II (Paddle) 75 Dilute HCl, pH 1.1 for 2 hours Acid stag
Release) and then add 200 mL of 0.1 N Buffer sta
NaOH in 200 mM Phosphate
Buffer. Adjust pH to 6.0 using 2
N HCl and/or 2N NaOH

Doxycycline Calcium Suspension Develop a dissolution method

Doxycycline Hyclate Tablet Refer to USP

Doxycycline Hyclate Capsule Refer to USP

Doxycycline Hyclate ( 120 mg and Tablet (Delayed I (Basket) 100 Acid stage: 0.06 N HCl; Buffer Acid stag
60 mg) Release) stage: Neutralized Phthalate Buffer sta
Buffer, pH 5.5 mL

Doxycycline Hyclate ( 150 mg and Tablet II (Paddle) 75 Water 900

75 mg)

Doxycycline Hyclate ( 200 mg, 150 Tablet (Delayed Refer to USP

mg, 100 mg, 80 mg and 75 mg) Release)

Doxycycline Hyclate ( 50 mg) Tablet (Delayed I (Basket) 100 Acid stage: 0.06 N HCl; Buffer 900
Release) stage: Neutralized Phthalate
Buffer, pH 5.5

Doxylamine Succinate/Pyridoxine Tablet (Extended II (Paddle) 100 Acid stage: 0.1 N HCl: Buffer Acid stag
HCl Release) stage: 0.2M sodium phosphate mL; Buffe
buffer pH 6.8 1000 mL

Dronabinol Capsule II (Paddle) 100 and 150 10% Labrasol in Water; (In 500
addition, the USP capsule
rupture test should also be
conducted)

Dronedarone HCl Tablet II (Paddle) with 75 pH 4.5 Phosphate buffer 1000

sinker

Drospirenone/Estradiol Tablet II (Paddle) 50 Water 900

Drospirenone/Ethinyl Estradiol Tablet Refer to USP

Drospirenone/Ethinyl Tablet II (Paddle) 50 Phosphate buffer pH 6.8, saline 900

Estradiol/Levomefolate Calcium with 0.03 % ascorbic acid

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Drug Name Dosage Form USP Apparatus Speed (RPMs) Medium Volume (

Droxidopa Capsule I (Basket) 100 0.1N HCl 900

Duloxetine HCl Capsule (Delayed Refer to USP

Release)

Dutasteride Capsule (Soft-Gelatin) II (Paddle) 50 Tier I: Dissolution Medium: 0.1 900

N HCI with 2% (w/v) sodium
dodecyl sulfate (SDS) (900 mL)
Tier II: Dissolution Medium: 0.1
N HCI with pepsin (as per USP)
(450 mL) for the first 25
minutes, followed by addition of
0.1 N HCI with SDS (4% w/v)
(450 mL) for the remainder of
the dissolution test.

Dutasteride/Tamsulosin HCl Capsule Dutasteride: II Dutasteride: 75 Dutasteride::Tier I: Dissolution Dutasteri

(Paddle) with Tamsulosin: 50 Medium: 1%w/v Tamsulos
sinker. cetyltrimethylammonium stage: 75
Tamsulosin: II bromide (CTAB) in 0.1 N HCl. stage: 10
(Paddle) Tier II: Dissolution Medium: 1%
w/v CTAB in 0.1 N HCl with
0.16% w/v pepsin. Tamsulosin::
Acid Stage (0-2 hrs): 0.1 N HCl.
Buffer stage: Add 250 mL of 0.2
M Sodium Phosphate Tribasic,
Dodecahydrate pH 6.8

Efavirenz Tablet II (Paddle) 50 2% SLS in water 1000

Efavirenz Capsule II (Paddle) A 50 1% Sodium Lauryl Sulfate in 900

sinker may be water
used with
justification if
necessary.

Efavirenz 600 mg; Emtricitabine Tablet II (Paddle) 100 2% SLS in water 1000
200 mg; Tenofovir Disoproxil
Fumarate 300 mg

Elbasvir/Grazoprevir Tablet I (Basket) 100 Phosphate Buffer, pH 6.8 with 900

0.45% (w/v) Polysorbate 80

Eletriptan Hydrobromide Tablet I (Basket) 100 0.1 N HCl 900

Eliglustat Tartrate Capsule II (Paddle) with 75 0.1 N HCl 900

sinker

Eltrombopag Olamine Tablet II (Paddle) 50 0.5% Polysorbate 80 in 900

Phosphate Buffer, pH 6.8

Eltrombopag Olamine Suspension II (Paddle) 50 50 mM potassium phosphate in 750

water, pH 6.8 with 0.2%
polysorbate 80

Eluxadoline Tablet I (Basket) 100 0.05M Phosphate Buffer, pH 900

4.5

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Dissolution Methods [Link]

Drug Name Dosage Form USP Apparatus Speed (RPMs) Medium Volume (

Elvitegravir Tablet II (Paddle) with 75 2.0% w/v Polysorbate 80 in 700 mL fo

sinker 0.01 N HCl (pH 2.0) at 37 ºC tablets; 1
150 mg ta
mL for 15
tablets

Empagliflozin Tablet II (Paddle) 75 0.05 M Phosphate Buffer, pH 900

6.8

Empagliflozin/ Metformin HCl Tablet (Extended I (Basket) 100 Phosphate Buffer, pH 6.8 900
Release)

Empagliflozin/Linagliptin Tablet II (Paddle) 50 pH 6.8 Phosphate Buffer 900

Empagliflozin/Metformin HCl Tablet II (Paddle) 50 Phosphate Buffer, pH 6.8 900

(degas)

Empagliflozin/Metformin Tablet II (Paddle) 50 Phosphate Buffer, pH 900

Hydrochloride 6.8 (deaerated)

Emtricitabine Capsule II (Paddle) 50 Tier 1: 0.1 N HCl Tier 2: 0.1 N 900

HCl containing Pepsin 750,000
USP units/L. Tier 2 is used after
failure of Tier 1 testing

Emtricitabine/Rilpivirine Tablet II (Paddle 75 Rilpivirine (RPV): 0.5% RPV: 100

HCl/Tenofovir Alafenamide Polysorbate 20 in 0.01 N HCl; and TAF:
Fumarate Emtricitabine (ETC) and
Tenofovir alafenamide (TAF):
50 mM Sodium Citrate, pH 5.5,

Emtricitabine/Rilpivirine Tablet II (Paddle) with 75 0.5%(w/w) polysorbate 20 in 1000

HCl/Tenofovir Disoproxil Fumarate sinker 0.01N HCl (pH 2.0)

Emtricitabine/Tenofovir Tablet II (Paddle 75 50 mM Sodium Citrate buffer, 500

Alafenamide Fumarate pH 5.5

Emtricitabine/Tenofovir Disoproxil Tablet II (Paddle) 50 0.01 N HCl 900

Fumarate

Enalapril Maleate Tablet Refer to USP

Entacapone Tablet II (Paddle) 50 Phosphate Buffer, pH 5.5 900

Entecavir Tablet II (Paddle) 50 Phosphate buffer pH 6.8 1000

(50mM)

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Dissolution Methods [Link]

Drug Name Dosage Form USP Apparatus Speed (RPMs) Medium Volume (

Enzalutamide Capsule II (Paddle) with 50 Tier 1 Medium: 0.3% cetyl 900

sinker trimethyl ammonium bromide
(CTAB) in 0.1 N HCl;Tier 2
Medium: 0.3% CTAB in 0.1 N
HCl containing Pepsin 600,000
USP units/L.

Eplerenone Tablet II (Paddle) 50 0.1 N HCl 1000

Eprosartan Mesylate Tablet II (Paddle) 75 0.2 M Phosphate Buffer, pH 7.5 1000

Eprosartan Tablet II (Paddle) 75 0.2 M Phosphate Buffer, pH 7.5 1000

Mesylate/Hydrochlorothiazide

Ergocalciferol Capsule II (Paddle) 100 0.5 N NaOH with 10% Triton- 500
X-100

Erlotinib HCl Tablet II (Paddle) 75 0.02% Tween 80 in 0.01 N HCl 1000

Erythromycin Tablet Refer to USP

Erythromycin Tablet (Delayed Refer to USP

Release)

Erythromycin Ethylsuccinate Suspension II (Paddle) 75 Monobasic Sodium Phosphate, 900

pH 6.8 Buffer with 1% SLS
Buffer w/ 1% SLS

Erythromycin Ethylsuccinate Oral granule Develop a dissolution method

Erythromycin Granules for Oral Develop a dissolution method

Ethylsuccinate/Sulfisoxazole Acetyl Suspension

Escitalopram Oxalate Capsule II (Paddle) 50 0.1 N HCl 900

Escitalopram Oxalate Tablet II (Paddle) 75 0.1 N HCl 900

Eslicarbazepine Acetate Tablet II (Paddle) 100 Acetate Buffer, pH 4.5 1000

Esomeprazole Magnesium Capsule (Delayed Refer to USP

Release Pellets)

Esomeprazole Magnesium Tablet (Delayed II (Paddle) 100 Acid stage: 0.1 N HCl; Buffer Acid stag
Release) stage: Phosphate Buffer, pH Buffer sta
6.8

Esomeprazole Magnesium For Oral Suspension II (Paddle 100 Acid stage: 0.1 N HCl; Buffer Acid stag
(Delayed Release) stage: Sodium Phosphate Buffer sta
Buffer, pH 6.8

Estazolam Tablet II (Paddle) 50 Water (deaerated) 900

Esterified Estrogens Tablet II (Paddle) 50 Water 900

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Drug Name Dosage Form USP Apparatus Speed (RPMs) Medium Volume (

Estradiol Vaginal Ring Incubator 130 0.9% Saline 250

shaker

Estradiol Vaginal Tablet I (Basket) 40 Phosphate Buffer, pH 4.75 ± 500

0.05

Estradiol (0.014 mg/24 hr) Film, Transdermal Develop a method to

(Extended Release) characterize in vitro release

Estradiol (0.025 mg/24 hr, 0.0375 Film, Transdermal Develop a method to

mg/24 hr, 0.05 mg/24 hr, 0.06 (Extended Release) characterize in vitro release
mg/24 hr, 0.075 mg/24 hr and 0.1
mg/24 hr)

Estradiol (Test 1) (0.025 mg/24 hr, Film, Transdermal VI 50 Water at 32 ± 0.5°C 0.025 mg
0.0375 mg/24 hr, 0.05 mg/24 hr, (Extended Release) (Cylinder) attach 0.0375 m
0.075 mg/24 hr and 0.1 mg/24 hr) the patch to a 500 mL; 0
disk at the hr, 0.075
bottom of the and 0.1 m
cylinder 900 mL

Estradiol (Test 2) (0.05 mg/24 hr Film, Transdermal V (Paddle over 50 Water at 32 ± 0.5°C 900
and 0.1 mg/24 hr) (Extended Release) Disk) with a
stainless steel
disk

Estradiol (Test 3) 0.0375 mg/24 hr, Film, Transdermal VI 50 Water at 32 ± 0.5°C 0.0375 m
0.05 mg/24 hr, 0.075 mg/24 hr and (Extended Release) (Cylinder) attach 500 mL; 0
0.1 mg/24 hr) the patch to the hr, 0.075
cylinder with and 0.1 m
double-sided 900 mL
tape

Estradiol/Norethindrone Acetate Tablet Refer to USP

Estradiol/Norgestimate Tablet II (Paddle) 50 0.3% SLS in water 500

(1mg/0.09mg)

Estramustine Phosphate Sodium Capsule I (Basket) 100 Water 900

Estrogens Conjugated Synthetic A Tablet I (Basket) 50 Water 900

Estrogens, Conjugated Tablet II (Paddle) with 50 EC: 0.02 M Na Acetate Buffer 900
(EC)/Medroxyprogesterone Acetate sinker (pH 4.5); MPA: 0.54% Sodium
(MPA) Lauryl Sulfate [SLS] in water

Estrogens, Conjugated Synthetic B Tablet II (Paddle) 50 Water 900

Eszopiclone Tablet II (Paddle) 50 0.1 N HCl 500

Ethacrynic Acid Tablet Refer to USP

Ethambutol HCl Tablet Refer to USP

Ethinyl Estradiol Tablet Refer to USP

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Dissolution Methods [Link]

Drug Name Dosage Form USP Apparatus Speed (RPMs) Medium Volume (

Ethinyl Estradiol/Ethynodiol Tablet II (Paddle) 75 0.25% Sodium Lauryl Sulfate 600

Diacetate (SLS) in Water

Ethinyl Estradiol/Etonogestrel Vaginal Ring Develop a method to

characterize in vitro release

Ethinyl Estradiol/Levonorgestrel Tablet Refer to USP

Ethinyl Estradiol/Levonorgestrel Tablet Refer to USP

(AB)

Ethinyl Estradiol/Levonorgestrel Tablet Refer to USP

(AB2)

Ethinyl Estradiol/Norethindrone Tablet (Chewable) II (Paddle) 75 0.09% Sodium Lauryl Sulfate in 500
0.1 N HCl

Ethinyl Estradiol/Norethindrone Tablet Refer to USP

Ethinyl Estradiol/Norethindrone Tablet Refer to USP

Acetate

Ethinyl Estradiol/Norethindrone Capsule II (Paddle) 100 Phosphate Buffer, pH 6.8, 900

Acetate containing 0.07% w/v Triton X
100

Ethinyl Estradiol/Norethindrone Tablet (Chewable) II (Paddle) 75 0.025 M Na Acetate Buffer with 500
Acetate [0.01mg,0.01 mg;1 mg] 0.15% Sodium Lauryl Sulfate
[SLS] (pH 5.0) [degassed]

Ethinyl Estradiol/Norethindrone Tablet (Chewable) II (Paddle) 75 0.025 M Sodium Acetate Buffer 600
Acetate [0.02mg;1mg] with 0.15% SLS, pH 5.0

Ethinyl Estradiol/Norgestimate Tablet II (Paddle) 75 0.05% Tween 20 in water 600

Ethinyl Estradiol/Norgestimate (AB) Tablet II (Paddle) 75 0.05% Tween 20 in water 600

Ethinyl Estradiol/Norgestrel Tablet II (Paddle) 75 Water with 5 ppm of Tween 80 500

Ethinyl Estradiol; Norelgestromin Film, Transdermal Modified USP 50 0.1% Hydroxypropyl-beta- 900
Type V (Paddle- cyclodextrin at 32º C
over-disk)

Ethionamide Tablet I (Basket) 75 0.1 N HCl 900

Ethosuximide Capsule Refer to USP

Etidronate Disodium Tablet Refer to USP

Etodolac Tablet (Extended Refer to USP

Release)

Etodolac Tablet Refer to USP

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Drug Name Dosage Form USP Apparatus Speed (RPMs) Medium Volume (

Etoposide Capsule Refer to USP

Etravirine (200 mg) Tablet II (Paddle) 70 1.0 % Sodium lauryl sulfate 1000 (ph
(SLS) in 0.01 M HCl in two 1800 (ph
phases: Phase 1: 1000 mL of
degassed 0.01 M HCl for 10
minutes. Phase 2: Add 800 mL
of 2.25% SLS in 0.01 M HCl.

Etravirine (25 and 100 mg) Tablet II (Paddle) 50 1.0 % Sodium lauryl sulfate 500 (pha
(SLS) in 0.01 M HCl in two (phase 2)
phases: Phase 1: 500 mL of
degassed 0.01 M HCl for 10
minutes. Phase 2: Add 400 mL
of 2.25% SLS in 0.01 M HCl.

Everolimus Tablet II (Paddle) 50 Water with 0.4% sodium 500

dodecylsulfate

Exemestane Tablet I (Basket) 100 0.5%(w/v) SLS Solution 900

Ezetimibe Tablet II (Paddle) 50 0.45% SLS in 0.05 M Acetate 500

Buffer, pH 4.5

Ezetimibe/Simvastatin Tablet II (Paddle) 50 0.01 M Sodium Phosphate, pH 900

7.0/0.5% SDS

Ezogabine Tablet II (Paddle) 75 0.01 N HCl 1000

Famciclovir Tablet II (Paddle) 50 0.1 N HCl 900

Famotidine Suspension II (Paddle) 25 and 50 0.1 M Phosphate buffer, pH 4.5 900

Famotidine Tablet (Orally II (Paddle) 50 0.1 M Phosphate Buffer, pH 900

Disintegrating) 4.5

Famotidine Tablet (Chewable) II (Paddle) 50 0.1 M Phosphate Buffer, pH 4.5 900

Famotidine Tablet Refer to USP

Famotidine/Calcium Tablet (Chewable) Develop a dissolution method

Carbonate/Magnesium Hydroxide

Famotidine/Ibuprofen Tablet II (Paddle) 50 0.05 M Phosphate Buffer, pH 900

7.2

Febuxostat Tablet II (Paddle) 75 0.05 M Phosphate Buffer, pH 900

6.0

Felbamate Suspension II (Paddle) 50 Water (deaerated) 900

Felbamate Tablet Refer to USP

Felodipine Tablet (Extended Refer to USP

Release)

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Dissolution Methods [Link]

Drug Name Dosage Form USP Apparatus Speed (RPMs) Medium Volume (

Fenofibrate Capsule (Micronized) II (Paddle) 75 0.025 M SLS in water 1000

Fenofibrate Capsule II (Paddle) 75 Phosphate Buffer w/ 2% Tween 900

80 and 0.1% pancreatin, pH 6.8

Fenofibrate (40 mg and 120 mg) Tablet II (Paddle 75 0.75% Sodium lauryl sulfate in 900
water

Fenofibrate (48 mg and 145 mg) Tablet II (Paddle 50 25 mM Sodium lauryl sulfate in 1000
water

Fenofibrate (54 mg and 160 mg) Tablet II (Paddle 50 0.05 M Sodium lauryl sulfate in 1000
water

Fenofibric Acid Tablet II (Paddle) 75 Phosphate buffer, pH 6.8 900

Fenoprofen Calcium Capsule Refer to USP

Fentanyl Transdermal VII 30 cycles per Equimolar mixture of 0.005 M 250 mL fo

(Reciprocating minute. amplitude of phosphoric acid solution, and and 100 m
holder)- about 2m. 0.005 M sodium phosphate, mL for th
cylinder. monobasic monohydrate (pH ~ mcg/hr an
2.6). at 32° C. Change the test for the 25
samples into fresh pre- mcg/hr do
equilibrated release medium at strength.
the time points indicated.
Remove the protective liner and
place the film onto a piece of
nylon netting with adhesive
facing the net. Secure the
netting and transdermal system
using nylon tie wraps at the top
and bottom of the cylinder on
the holder. The adhesive side
faces towards the media.

Fentanyl Citrate Lozenges II (Paddle) 175 0.1 M Phosphate Buffer, pH 4.5 500

Fentanyl Citrate Tablet (Sublingual) II (Paddle) 50 Phosphate Buffer, pH 6.8 500

Fentanyl Citrate (0.1 mg and 0.4 Tablet (Buccal) II (Paddle) small 100 Phosphate Buffered Saline 100
mg) volume solution, pH 7.0
dissolution
apparatus

Fentanyl Citrate (0.2 mg, 0.3 mg, Tablet (Buccal) II (Paddle) small 100 Phosphate Buffered Saline 200
0.6 mg and 0.8 mg) volume solution, pH 7.0
dissolution
apparatus

Fentanyl Citrate (0.2 mg, 0.4 mg, Film (Buccal) I (Basket) 100 100 25-mM Phosphate Buffer, pH 60
0.6 mg and 0.8 mg) mL dissolution 6.4
vessel

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Dissolution Methods [Link]

Drug Name Dosage Form USP Apparatus Speed (RPMs) Medium Volume (

Fentanyl Citrate (1.2 mg) Film (Buccal) I (Basket) 100 100 25-mM Phosphate Buffer, pH 100
mL dissolution 6.4
vessel

Ferric Citrate Tablet II (Paddle) 100 EDTA media ( 2.0 grams of 900
EDTA Na2 2H2O to 1000 mL of
purified water)

Ferrous Fumarate Tablet Refer to USP

Fesoterodine Fumarate Tablet (Extended II (Paddle) with 75 Phosphate Buffer, pH 6.8 900
Release) sinker

Fexofenadine HCl Tablet (Orally II (Paddle) 50 0.001 N HCl 500

Disintegrating)

Fexofenadine HCl Suspension II (Paddle) 50 0.001 N HCl 900

Fexofenadine HCl Tablet II (Paddle) 50 0.001 N HCl 900

Fexofenadine HCl Capsule II (Paddle) 50 Water (deaerated) 900

Fexofenadine Tablet (Extended Refer to USP

HCl/Pseudoephedrine HCl Release)

Fidaxomicin Tablet II (Paddle) 75 Water with 2% Tween 80 900

Finafloxacin Otic Suspension Develop a method to

characterize in vitro release

Finasteride Tablet Refer to USP

Fingolimod Capsule I (Basket) 100 0.1 N HCl with 0.2% SDS 500
(sodium dodecyl sulfate)

Flavoxate HCl Tablet I (Basket) 100 0.1 N HCl 900

Flecainide Acetate Tablet Refer to USP

Flibanserin Tablet II (Paddle) 50 Mcilvaine Buffer (Citric 900

Acid/Phosphate Buffer), pH 4.0

Fluconazole Tablet II (Paddle) 50 Water (deaerated) 900 (For

300 & 40
500 (For
mg tabs)

Fluconazole (200 mg/5 mL) Suspension II (Paddle) 50 Water (deaerated) 900

Fluconazole (50 mg/5 mL) Suspension II (Paddle) 50 Water (deaerated) 500

Flucytosine Capsule Refer to USP

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Dissolution Methods [Link]

Drug Name Dosage Form USP Apparatus Speed (RPMs) Medium Volume (

Fludarabine Phosphate Tablet II (Paddle) 50 Water 900

Fludrocortisone Acetate Tablet Refer to USP

Fluoxetine Capsules (Delayed Refer to USP

Release)

Fluoxetine HCl Capsule Refer to USP

Fluoxetine HCl Tablet Refer to USP

Fluoxetine/Olanzapine Capsule II (Paddle) 50 0.1 N HCl 900

Fluphenazine HCl Tablet Refer to USP

Flutamide Capsule Refer to USP

Fluvastatin Sodium Capsule Refer to USP

Fluvastatin Sodium Tablet (Extended I (Basket) 50 Water (deaerated) 1000

Release)

Fluvoxamine Maleate Capsule (Extended II (Paddle) 50 Phosphate Buffer, pH 6.8 900

Release)

Fluvoxamine Maleate Tablet II (Paddle) 50 Water (deaerated) 900

Fosamprenavir Calcium Tablet II (Paddle) 75 250 mM Sodium Acetate/Acetic 900

acid buffer pH 3.5

Fosamprenavir Calcium Oral Suspension II (Paddle) 25 10 mM HCl 900

Fosfomycin Tromethamine For Suspension Develop a dissolution method

Fosinopril Sodium Tablet II (Paddle) 50 Water (deaerated) 900

Fosinopril Tablet Refer to USP

Sodium/Hydrochlorothiazide

Frovatriptan succinate Tablet II (Paddle) 50 Phosphate Buffer pH 5.5 900

Furosemide Tablet Refer to USP

Gabapentin Tablet Refer to USP

Gabapentin Capsule Refer to USP

Gabapentin Enacarbil Tablet (Extended II (Paddle) 50 10 mM Phosphate buffer at pH 500 (for 3

Release) 7.4 with 1.0 % SLS 900 (for 6

Galantamine HBr Tablet Refer to USP

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Dissolution Methods [Link]

Drug Name Dosage Form USP Apparatus Speed (RPMs) Medium Volume (

Galantamine HBr Capsule (Extended II (Paddle) 50 50 mM potassium dihydrogen 900

Release) phosphate buffer pH 6.5
Comparative dissolution data
should also be provided in 900
ml pH 0.1 HCl, pH 4.5 buffer,
and water using Apparatus II
(Paddle) at 50 RPM.

Ganciclovir Capsule II (Paddle) 60 Water (deaerated) 900

Gefitinib Tablet II (Paddle) 50 Tween 80 (5% v/v) in water 1000

Gemfibrozil Tablet Refer to USP

Gemifloxacin Mesylate Tablet II (Paddle) 50 0.01 N HCl 900

Glimepiride Tablet II (Paddle) 75 Phosphate Buffer, pH 7.8 900

Glimepiride/Pioglitazone HCl Tablet II (Paddle) 75 For Pioglitazone: pH 2.0, HCl 900

Buffer. For Glimepiride: pH 6.8,
Sodium Phosphate Buffer with
0.2% sodium dodecyl sulfate

Glimepiride/Rosiglitazone Maleate Tablet II (Paddle) 75 0.01 M HCl with 0.5% Sodium 900
Dodecyl Sulfate

Glipizide Tablet (Extended II (Paddle) 50 Simulated Intestinal Fluid 900

Release) without pancreatin, pH 7.5

Glipizide Tablet Refer to USP

Glipizide/Metformin HCL Tablet Refer to USP

Glyburide (Micronized) Tablet II (Paddle) 50 0.05 M Phosphate Buffer, pH 900

7.5

Glyburide (Non-micronized) Tablet II (Paddle) 75 0.05 M Borate Buffer, pH 9.5 500

Glyburide/Metformin HCl Tablet Refer to USP

Glycopyrrolate Tablet Refer to USP

Goserelin Acetate Implant Prior to Swirl orbit of 50 mm Each implant should be 50

sampling, the jar at 205 rpm for 6 incubated in 50 mL of
is removed from seconds phosphate buffered saline, pH
incubation and 7.4, at 39°C (warmed overnight
mechanically before the implants are added),
swirled with in a 120-mL Wheaton jar.
digital orbital
shaker

Granisetron Injectable (Extended Develop a method to

Release) characterize in vitro release

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Dissolution Methods [Link]

Drug Name Dosage Form USP Apparatus Speed (RPMs) Medium Volume (

Granisetron Film, Transdermal VI (Cylinder) 50 80 microL /L phosphoric acid 1000

(Extended Release) (85%) at 32 ± 0.5°C

Granisetron HCl Tablet II (Paddle) 50 Phosphate buffer, pH 6.5 500

Griseofulvin Oral Suspension II (Paddle) 25 and 50 0.54% Sodium Lauryl Sulfate 1000
(SLS) in Water

Griseofulvin (Microcrystalline) Oral Suspension II (Paddle) 25 and 50 0.54% Sodium Lauryl Sulfate 1000
(SLS) in Water

Griseofulvin (Microcrystalline) Tablet Refer to USP

Griseofulvin (Ultramicrocrystalline) Tablet Refer to USP

Guaifenesin Tablet (Extended I (Basket) 75 0.1 N HCl 900

Release)

Guaifenesin/Pseudoephedrine Tablet (Extended I (Basket) 50 0.01 N HCl 900

Hydrochloride Release)

Guanfacine Tablet (Extended II (Paddle) 75 HCl Buffer, pH 2.2 900

Release)

Haloperidol Tablet Refer to USP

Homatropine Tablet Refer to USP

Methylbromide/Hydrocodone
Bitartrate

Hydralazine HCl Tablet Refer to USP

Hydrochlorothiazide Capsule I (Basket) 100 0.1 N HCl 900

Hydrochlorothiazide Tablet Refer to USP

Hydrochlorothiazide/Irbesartan Tablet II (Paddle) 50 0.1 N HCl 1000

Hydrochlorothiazide/Lisinopril Tablet II (Paddle) 50 0.1 N HCl 900

Hydrochlorothiazide/Losartan Tablet I (Basket) 100 Water (deaerated) 900

Potassium

Hydrochlorothiazide/Metoprolol Tablet (Extended II (Paddle) Hydrochlorothiazide: Hydrochlorothiazide: 0.1N HCl; Hydrochl

Succinate Release) 100; Metoprolol Metoprolol succinate: 500; Meto
succinate: 75 Phosphate Buffer, pH 6.8 succinate

Hydrochlorothiazide/Metoprolol Tablet Refer to USP

Tartrate

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Dissolution Methods [Link]

Drug Name Dosage Form USP Apparatus Speed (RPMs) Medium Volume (

Hydrochlorothiazide/Moexipril HCl Tablet II (Paddle) 50 0.1 N HCl 900

Hydrochlorothiazide/Olmesartan Tablet II (Paddle) 50 0.05 M Phosphate Buffer, pH 900

Medoxomil 6.8

Hydrochlorothiazide/Quinapril HCl Tablet I (Basket) 100 Water (deaerated) 900

Hydrochlorothiazide/Spironolactone Tablet Refer to USP

Hydrochlorothiazide/Telmisartan Tablet Refer to USP

Hydrochlorothiazide/Triamterene Tablet Refer to USP

Hydrochlorothiazide/Valsartan Tablet Refer to USP

Hydrochlorothizide/Triamterene Capsule Refer to USP

Hydrocodone Bitartrate Capsule (Extended I (Basket) 100 0.05 M Phosphate Buffer, pH 500
Release) 6.8

Hydrocodone Bitartrate Tablet (Extended I (Basket-10 100 Simulated gastric fluid (SGF) 900
Release) mesh) without enzyme (pH 1.2)

Hydrocodone Bitartrate/Ibuprofen Tablet II (Paddle) 50 Phosphate Buffer, pH 7.2 900

Hydrocortisone Tablet Refer to USP

Hydromorphone HCl Tablet Refer to USP

Hydromorphone HCl Tablet (Extended VII 30 cycles per min Water 50

Release) (Reciprocating
holder) (Sample
holder-Cage)

Hydroxyurea Capsule Refer to USP

Hydroxyzine HCl Tablet Refer to USP

Hydroxyzine Pamoate Capsule Refer to USP

Hydroxyzine Pamoate Suspension Develop a dissolution method

Ibandronate Sodium Tablet II (Paddle) 50 Water 500

Ibrutinib Capsule II (Paddle) 75 3.0% w/v Polysorbate 20 in 50 900

mM Phosphate Buffer, pH 6.8

Ibuprofen Tablet Refer to USP

Ibuprofen Capsule (Soft- I (Basket) 150 50mM Phosphate Buffer, pH 900

Gelatin/Liquid Fill) 7.2

Ibuprofen Tablet (Chewable) II (Paddle) 50 0.05 M Phosphate Buffer, pH 900

7.2

Ibuprofen Suspension Refer to USP

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Dissolution Methods [Link]

Drug Name Dosage Form USP Apparatus Speed (RPMs) Medium Volume (

Ibuprofen Suspension/Drop II (Paddle) 50 Phosphate Buffer, pH 7.2 900

Ibuprofen Potassium Capsule (Soft- I (Basket) 150 Phosphate Buffer, pH 7.2 900
Gelatin/Liquid Fill)

Ibuprofen Sodium Capsule I (Basket) 150 Phosphate Buffer, pH 7.2 900

Ibuprofen/Diphenhydramine Capsule I (Basket) 100 Phosphate Buffer (200 mM), 900

pH7.2

Ibuprofen/Oxycodone HCl Tablet I (Basket) 100 Phosphate buffer, pH 7.2 500

Ibuprofen/Phenylephrine HCl Tablet II (Paddle) 50 50 mM Potassium Phosphate 900

Buffer, pH 6.5, (degassed)

Ibuprofen/Pseudoephedrine HCl Capsule I (Basket) 150 Tier 1: 0.05 M phosphate buffer, 900
pH 7.2 Tier 2: 0.05 M
phosphate buffer, pH 7.2 with
NMT 1750 USP protease
units/L of 1 X USP pancreatin

Ibuprofen/Pseudoephedrine HCl Suspension II (Paddle) 50 0.05 M Phosphate Buffer, pH 900

7.2

Icosapent Ethyl Capsule Develop an in vitro release

method using USP IV (Flow-
Through Cell), and, if
applicable, Apparatus II
(Paddle) or any other
appropriate pharmacopoeial
apparatus, for comparative
evaluation by the Agency.

Idelalisib Tablet II (Paddle) 75 0.01 N HCl 750

Iloperidone Tablet II (Paddle) 50 0.1 N HCl 500

Imatinib Mesylate Tablet II (Paddle) 50 0.1 N HCl 1000

Imipramine HCl Tablet Refer to USP

Imipramine Pamoate Capsule I (Basket) 100 0.1 N HCl without pepsin and 900
with 0.3% pepsin (addition of
pepsin is recommended only
when significant slow
dissolution is observed)

Indapamide Tablet Refer to USP

Indinavir Sulfate Capsule II (Paddle) 50 0.1 M Citrate Buffer, pH 3.8 900

Indomethacin Capsule (Extended Refer to USP

Release)

Indomethacin (40 mg and 20 mg) Capsule I (Basket) 100 10 mM citric acid buffer, pH 750
5.75

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Drug Name Dosage Form USP Apparatus Speed (RPMs) Medium Volume (

Indomethacin (50 and 25 mg) Capsule Refer to USP

Irbesartan Tablet Refer to USP

Isavuconazonium Sulfate Capsule II (Paddle) with 75 Diluted McIlvaine Buffer [12.5 900
sinker mM disodium hydrogen
phosphate solution +6.25 mM
citric acid solution ] + 0.5 %
Sodium Lauryl sulfate (SLS)

Isocarboxazid Tablet II (Paddle) 50 0.1 N HCl 900

Isoniazid Tablet Refer to USP

Isosorbide Dinitrate Capsule (Extended Refer to USP

Release)

Isosorbide Dinitrate Tablet (Extended Refer to USP

Release)

Isosorbide Dinitrate Tablet Refer to USP

Isosorbide Dinitrate/Hydralazine Tablet I (Basket) 100 0.05 N HCl 900

HCl

Isosorbide Mononitrate Tablet II (Paddle) 50 Water (deaerated) 900

Isosorbide Mononitrate Tablet (Extended Refer to USP

Release)

Isotretinoin Capsule I (Basket, with 100 0.05 M Potassium Phosphate 900

20 mesh) Buffer, dibasic, pH 7.8,
containing 0.5% solid LDAO

Isradipine Capsule II (Paddle) 50 0.1% Lauryl Dimethylamine 500

Oxide (LDAO) in water

Isradipine (10 mg) Tablet (Extended II (Paddle) 50 0.2% Lauryl Dimethylamine 1000
Release) Oxide (LDAO) in water

Isradipine (5 mg) Tablet (Extended II (Paddle) 50 0.2% Lauryl Dimethylamine 500

Release) Oxide (LDAO) in water

Itraconazole Capsule II (Paddle) 100 SGF without Enzyme 900

Itraconazole Tablet II (Paddle) 75 0.1 N HCl 900

Ivabradine HCl Tablet Develop a dissolution method

Ivacaftor Tablet II (Paddle) with 65 50 mM Sodium Phosphate 900

sinker Buffer with 0.7% Sodium
Dodecyl Sulfate (SDS), pH 6.8

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Drug Name Dosage Form USP Apparatus Speed (RPMs) Medium Volume (

Ivacaftor/lumacaftor Tablet Lumacaftor: II Lumacaftor:65; Lumacaftor: 0.5% (w/v) CTAB Lumacaft

(Paddle); Ivacaftor: 65 in 50 mM Sodium Acetate Ivacaftor:
Ivacaftor: II Trihydrate buffer (pH 4.5);
(Paddle) Ivacaftor: 0.4% (w/v) SLS in 50
mM Sodium Phosphate buffer
(pH 6.8)

Ivacaftor/Tezacaftor [FDC: IVA+ Tablet/Tablet II (Paddle) with FDC: IVA: FDC: IVA: 50 mM Sodium FDC: IVA
TEZ]; Ivacaftor [IVA] (Copackage) option to use a 65/TEZ:75; IVA: 65 Phosphate Buffer with 0.4% 900; IVA:
sinker Sodium Dodecyl Sulfate (SDS),
pH 6.8/TEZ: 0.2 SDS% in 0.1 N
HCl; IVA: 50 mM Sodium
Phosphate Buffer with 0.7%
SDS, pH 6.8;

Ivermectin Tablet II (Paddle) 50 0.5% SDS in 0.01 M Monobasic 900

Sodium Phosphate, pH 7.0

Ixazomib Citrate Capsule I (Basket) 100 0.1 N HCl 500

Ketoconazole Tablet I (Basket) 100 Simulated gastric fluid w/o 800

pepsin

Ketoprofen Tablet II (Paddle) 50 SIF Buffer without enzyme, pH 900

7.4

Ketoprofen Capsule II (Paddle) 50 0.05 M Phosphate Buffer pH 1000

7.4

Ketorolac Tromethamine Tablet Refer to USP

Labetalol HCl Tablet Refer to USP

Lacosamide Tablet II (Paddle) 50 0.1 N HCl 900

Lamivudine Tablet Refer to USP

Lamivudine 150 mg/Zidovudine Tablet II (Paddle) 75 0.1 N HCl 900

300mg Tablets and Abacavir
Sulfate 300 mg Tablets-co-
packaged

Lamivudine/Raltegravir Ka Tablet II (Paddle) 75 Water 900

Lamivudine/Stavudine/Nevirapine Tablet II (Paddle) 75 0.1 N HCl 900

Lamivudine/Zidovudine Tablet Refer to USP

Lamivudine/Zidovudine + Efavirenz Tablet (Copackage) II (Paddle) Lamivudine and Lamivudine and Zidovudine: Lamivudi
Zidovudine: 75 0.1 N HCl Efavirenz: 2% SLS in Zidovudin
Efavirenz: 50 water Efavirenz

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Drug Name Dosage Form USP Apparatus Speed (RPMs) Medium Volume (

Lamivudine/Zidovudine + Tablet (Copackage) II (Paddle) 50 Lamivudine and Zidovudine: 900

Nevirapine water Nevirapine: 0.06 M HCl
(pH 1.2)

Lamivudine/Zidovudine/ Nevirapine Tablet II (Paddle) 50 0.01 N HCl 900

Lamotrigine Tablet (Regular) II (Paddle) 50 0.1 N HCl 900

Lamotrigine Tablet (Chewable II (Paddle) 50 0.1 N HCl 900

dispersible)

Lamotrigine Tablet (Extended Refer to USP

Release)

Lansoprazole Capsule (Delayed Refer to USP

Release)

Lansoprazole Tablet (Delayed II (Paddle) 75 Acid Stage: 0.1 N HCl; Buffer 500 (Acid
Release, Orally Stage: Phosphate Buffer, pH (Buffer)
Disintegrating) 6.8 with 5 mM Sodium Dodecyl
Sulfate

Lanthanum Carbonate Chewable Tablet Reciprocating 10 dpm (dip rate per 0.25 N HCl 900 (mod
Cylinder minute) the stand
(Apparatus 3 apparatu
modified) to achiev
condition

Lapatinib Ditosylate Tablet II (Paddle) 55 2% Polysorbate 80 in 0.1 N HCl 900

Ledipasvir/Sofosbuvir Tablet II (Paddle) 75 1.5% Polysorbate 80 in 10 mM 900

Potassium Phosphate Buffer
with 0.0075 mg/mL Butylated
Hydroxytoluene (BHT), pH 6.0

Leflunomide Tablet II (Paddle) 100 Water (deaerated) 1000

Leflunomide (100 mg) Tablet II (Paddle) 100 Water (deaerated) + 0.6% 1000
Polyoxyethylene Lauryl Ether

Lenalidomide Capsule II (Paddle) 50 0.01 N HCl 900

Lenvatinib Mesylate Capsule II (Paddle) 50 0.1 N HCl 900

Lesinurad Tablet II (Paddle) 75 pH 4.5 sodium acetate buffer 900

with 1% SLS

Letermovir Tablet II (Paddle) 75 25 mM Na Acetate Buffer, pH 900

4.5 with 0.6% Tween-80

Letrozole Tablet Refer to USP

Letrozole (LET); Ribociclib Tablet/Tablet II (Paddle) RIB: 50; LET: 75 RIB: 0.01 N HCl; LET: 0.1 N RIB: 900;
Succinate (RIB) (Copackage) HCl

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Drug Name Dosage Form USP Apparatus Speed (RPMs) Medium Volume (

Leucovorin Calcium Tablet Refer to USP

Leuprolide Acetate Injectable (Extended Develop a dissolution method

Release) using USP IV (Flow-Through
Cell), and, if applicable,
Apparatus II (Paddle) or any
other appropriate method, for
comparative evaluation by the
Agency

Levetiracetam Tablet, for Suspension II (Paddle) 50 Phosphate Buffer, pH 6.8 900

(degas)

Levetiracetam Tablet (Extended I (Basket) 100 0.05 M Phosphate Buffer, pH 900

Release) 6.0

Levetiracetam Tablet II (Paddle) 50 Water (deaerated) 900

Levocarnitine Tablet Refer to USP 900

Levocetirizine Dihydrochloride Tablet II (Paddle) 50 Water 900

Levofloxacin Tablet Refer to USP

Levomilnacipran HCl Capsule (Extended II (Paddle) 75 Water (deaerated) 1000

Release)

Levonorgestrel Tablet II (Paddle) 75 0.1 N HCl with 0.1% SLS 1000

Levonorgestrel Intrauterine Device Develop a method to

characterize in vitro release

Levothyroxine Sodium Tablet Refer to USP

Lidocaine Topical Patch Paddle over 50 Acetic acid/sodium acetate 500

Disk (Apparatus buffer, pH 4.0 at 32ºC
5)

Linaclotide Capsule I (Basket) 50 50 mM Phosphate Buffer, pH 500

4.5

Linagliptin Tablet I (Basket) 50 0.1 N HCl 900

Linagliptin/Metformin HCl Tablet II (Paddle) 50 0.1 N HCl 900

Linagliptin/Metformin HCl Tablet (Extended I (Basket) 100 Simulated Gastric Fluid (SGF) 900
Release) without enzyme (pH 1.2)
(degassed)

Linezolid Tablet II (Paddle) 50 0.05 M Phosphate Buffer, pH 900

6.8

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Drug Name Dosage Form USP Apparatus Speed (RPMs) Medium Volume (

Linezolid Suspension II (Paddle) 50 0.05 M Phosphate Buffer, pH 900

6.8

Liothyronine Sodium Tablet Refer to USP

Lisdexamfetamine Dimesylate Capsule II (Paddle) 50 0.1 N HCl 900

Lisinopril Tablet Refer to USP

Lithium Carbonate Tablet (Extended Refer to USP

Release)

Lithium Carbonate Tablet Refer to USP

Lithium Carbonate Capsule Refer to USP

Lomefloxacin HCl Tablet II (Paddle) 50 0.01 N HCl 900

Lomitapide Mesylate Capsule II (Paddle) 50 0.001 N HCl with 0.1% 500 mL (

Polysorbate 80 strength)
(10 and 2
strength)

Lomustine Capsule Develop a dissolution method

Loperamide HCl Capsule Refer to USP

Loperamide HCl Tablet Refer to USP (provide

individual unit data).

Loperamide HCl Oral Suspension II (Paddle) 25 0.01 N HCl 900

Loperamide HCl Tablet (Chewable) II (Paddle) 50 0.2 M Acetate Buffer, pH 4.7 500

Loperamide HCl/Simethicone Tablet II (Paddle) 75 0.1N HCl 500

Lopinavir/Ritonavir Capsule (Soft-Gelatin) II (Paddle) 50 Tier 1: 0.05 M Polyoxyethylene 900

10 Lauryl Ether with 10 mM
Sodium Phosphate monobasic
(pH 6.8); Tier II: same as above
with NMT 1750 USP units/L of
Pancreatin

Lopinavir/Ritonavir Tablet (Combination) Refer to USP

Loratadine Tablet (Orally I (Basket) 50 SGF without enzyme 900

Disintegrating)

Loratadine Capsule (Soft-Gelatin) II (Paddle) with 75 Tier I: 0.1N HCl with 0.1% 900
sinker Tween 20. Tier II: 0.1N HCl with
0.1% Tween 20 with addition of
pepsin (as per USP).

Loratadine Tablet (Chewable) II (paddle) 50 0.1 N HCl 500

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Drug Name Dosage Form USP Apparatus Speed (RPMs) Medium Volume (

Loratadine/Pseudoephedrine Tablet (Extended I (Basket) 75 900 mL 0.1 N HCl for one hour, 900
Sulfate (10 mg /240 mg) Release) then replace the medium with
900 mL 0.05 M phosphate
buffer at pH6.8 containing
0.01% sodium lauryl sulfate.

Loratadine/Pseudoephedrine Tablet (Extended II (Paddle) 50 900 mL 0.1 N HCl for one hour, 900
Sulfate (5 mg /120 mg) Release) then replace with 900 mL 0.05
M phosphate buffer at pH 8.2
containing 0.01% sodium lauryl
sulfate

Lorazepam Tablet Refer to USP

Lorcaserin HCl Tablet (Extended I (Basket) 100 0.1 N HCl (deaerated) 900
Release)

Lorcaserin HCl Tablet II (Paddle) 50 0.1 N HCl (deaerated) 900

Losartan Potassium Tablet Refer to USP

Losartan Potassium Tablet II (Paddle) 50 Water (deaerated) 900

Loteprednol Etabonate Ophthalmic Develop a method to

Suspension characterize in vitro release

Loteprednol Etabonate/Tobramycin Ophthalmic Develop a method to

Suspension characterize in vitro release

Lovastatin Tablet (Extended II (Paddle) 50 0.5% sodium lauryl sulfate 900

Release) (SLS) / sodium phosphate
buffer (0.01M), pH 6.5

Lovastatin/Niacin Tablet (Extended I (Basket) 100 For Niacin: Water; for 900
Release) Lovastatin: 0.05 M phosphate
buffer, pH 7.0 with 0.5% sodium
dodecyl sulfate

Lubiprostone Capsule (Soft-Gelatin) II (Paddle) 50 0.1 N HCl/1% HCO-40 900

(Polyoxyl 40 hydrogenated
castor oil)

Lurasidone HCl Tablet II (Paddle) 50 McIlvaine buffer, pH 3.8 [(0.025 900

M Citric acid Solution + 0.05M
Na2HPO4 solution
(3:2)] Measure the pH and
adjust to 3.8, if necessary.
Degas before use.

Macitentan Tablet II (Paddle) 75 Phosphate Buffer, pH 6.8 with 900

0.1% of Cetrimonium bromide
(CTAB)

Magnesium Hydroxide/Omeprazole Tablet (Chewable) II (Paddle) 150 pH 7.4 Phosphate Buffer with 900
/Sodium Bicarbonate 0.5% SDS

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Drug Name Dosage Form USP Apparatus Speed (RPMs) Medium Volume (

Magnesium Hydroxide/Omeprazole Tablet (Chewable) II (Paddle) 150 0.029 M sodium phosphate 900
/Sodium Bicarbonate buffer w/ 0.5% SDS, pH 7.4

Maraviroc Tablet I (Basket) 100 0.01 N HCl 900

Mebendazole Tablet (Chewable) II (Paddle) 75 0.1 N HCl containing 1% 900

Sodium Lauryl Sulfate

Mebendazole ( 500 mg) Tablet (Chewable) II (Paddle) 75 1% Sodium Lauryl Sulfate 900
(SLS) in 0.01 N HCl

Mecamylamine HCl Tablet Refer to USP

Meclizine HCl Tablet (Chewable) I (Basket) 100 0.01 N HCl 900

Meclizine HCl Tablet I (Basket) 100 0.01 N HCl 900

Medroxyprogesterone Acetate Injectable Suspension Test 1: IV (Flow Test 1: 17 mL/min; Test 1: 0.5 % SDS in water ; Test 1:us
through cell), Test 2: 50 rpm Test 2: 0.35 % SDS in water Mode: Te
22.6 mm cell, 13 (provide data with both tests) mL
g of 1 mm
beads; Test 2: II
(Paddle)

Medroxyprogesterone Acetate Tablet Refer to USP

Medroxyprogesterone Acetate Injectable Suspension Develop a method to

(104mg/0.65ml) characterize in vitro release

Mefenamic Acid Capsule Refer to USP

Mefloquine HCl Tablet I (Basket) 100 SGF without enzyme 900

Megestrol Acetate Oral Suspension Refer to USP

Meloxicam Suspension II (Paddle) 25 Phosphate buffer at pH 7.5 900

Meloxicam Tablet II (Paddle) 75 Phosphate Buffer, pH 7.5 900

Meloxicam Capsule I (Basket) 100 Phosphate Buffer, pH 6.1 with 500 mL (

0.1% Sodium Lauryl Sulfate 1000 mL
(SLS)

Melphalan Tablet Refer to USP

Memantine HCl Capsule (Extended I (Basket) 100 pH 1.2 NaCl/HCl Buffer (degas) 900
Release)

Memantine HCl Tablet I (Basket) 100 0.1 N HCl with NaCl (12 g NaCl 900
in 6 L water adjust pH to 1.2
with HCl)

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Drug Name Dosage Form USP Apparatus Speed (RPMs) Medium Volume (

Menthol/Methyl Salicylate Topical Patch VI (Cylinder) 50 Neutralized phthalate buffered 900

solution (0.2 M potassium
biphthalate) with pH of 5.0 at 32
± 0.5°C

Meprobamate Tablet Refer to USP

Mercaptopurine Tablet II (Paddle) 50 0.1 N HCl 900

Mercaptopurine Oral Suspension II (Paddle) 50 0.1N HCl 900

Mesalamine Capsule (Delayed II (Paddle) Phase 1 & 2: 100 Phase 1: 0.1N HCl (degas); Phase 1:
Release) rpm; Phase 3: 50 Phase 2: pH 6.0 Buffer (degas); Phase 2:
rpm Phase 3: pH 7.2 Buffer Phase 3:

Mesalamine Suppository II (Paddle) with 75 (for 500 mg) & For 500 mg strength: 0.2 M 900
option to use a 125 (for 1000 mg) Phosphate buffer, pH 7.5 at 37
sinker deg. C For 1000 mg strength:
0.2 M Phosphate buffer, pH 7.5
at 40 deg. C

Mesalamine (1.2 gram) Tablet (Delayed II (Paddle) 100 Acid stage (A): 100 mM HCl Acid stag
Release) Buffer stage (B): Phosphate mL; Buffe
Buffer, pH 6.4 Buffer stage (C): (B): 950 m
Phosphate Buffer, pH 7.2 stage (C)

Mesalamine (250 mg and 500 mg) Capsule (Extended Refer to USP

Release)

Mesalamine (375 mg) Capsule (Extended I (Basket) 100 Acid Stage: 0.1N HCl Buffer Acid stag
Release) stage: Phosphate Buffer, pH Buffer sta
6.8 mL

Mesalamine (400 mg and 800 mg) Tablet (Delayed Refer to USP

Release)

Mesalamine Enema Rectal Enema II (Paddle) 50 Phosphate Buffer, pH 7.2 900

Mesna Tablet II (Paddle) 50 0.06 N HCl 500

Mestranol/Norethindrone Tablet Refer to USP

Metaxalone Tablet Refer to USP

Metformin HCl Tablet Refer to USP

Metformin HCl Tablet (Extended Refer to USP

Release)

Metformin HCl/Pioglitazone HCl Tablet II (Paddle) 50 pH 2.5 McIlvaine buffer (0.1 M 900
Citric acid adjusted to pH 2.5
with 0.2 M Na2HPO4)

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Drug Name Dosage Form USP Apparatus Speed (RPMs) Medium Volume (

Metformin HCl/Saxagliptin Tablet (Extended I (Basket) 100 Phosphate Buffer, pH 6.8 1000
Release)

Metformin HCl/Sitagliptin Tablet II (Paddle) 75 0.025 M NaCl 900

Phosphate

Metformin/Repaglinide Tablet II (Paddle) 50 Citric acid/phosphate buffer, pH 900

5.0

Methadone HCl Tablet Refer to USP

Methazolamide Tablet II (Paddle) 100 pH 4.5 Acetate Buffer 900

Methenamine Hippurate Tablet Refer to USP

Methimazole Tablet Refer to USP

Methocarbamol Tablet Refer to USP

Methotrexate Sodium Tablet Refer to USP

Methoxsalen Capsule Refer to USP

Methscopolamine Bromide Tablet Refer to USP

Methylergonovine Maleate Tablet Refer to USP

Methylnaltrexone Bromide Tablet II (Paddle) 50 0.1 N HCl 1000

Methylphenidate Capsule (Extended II (Paddle) 50 Water 500

Release)

Methylphenidate Transdermal Patch VI (Cylinder) 50 0.01 N HCl at 32ºC 900

Methylphenidate Tablet (Extended II (Paddle) 75 Acid Stage: 0.1 N HCl; Buffer Acid Stag
Release, Orally Stage: Phosphate Buffer, pH Buffer Sta
Disintegrating ) 6.8 mL

Methylphenidate Tablet (Extended Refer to USP

Release)

Methylphenidate (BX) Capsule (Extended I (Basket) 75 0-2 hrs:0.01 N HCl. 2-10 hrs: 0-2 hrs: 5
Release) Phosphate Buffer, pH 6.8. hrs:500

Methylphenidate HCl Tablet Refer to USP (provide

individual unit data).

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Dissolution Methods [Link]

Drug Name Dosage Form USP Apparatus Speed (RPMs) Medium Volume (

Methylphenidate HCl Tablet (Extended II (Paddle) 75 0.4M KH2PO4 solution (degas) 900
Release, Chewable)

Methylphenidate HCl Powder for Suspension II (Paddle) 75 0.4 M Phosphate Buffer, pH 4.5 900
(Extended Release)

Methylphenidate HCl Tablet (Chewable) I (Basket) 100 Water 900

Methylphenidate HCl Capsule (Extended I (Basket) 100 Acid Stage:(First 2 hours) 0.01 Acid: 500
Release) N HCl; Buffer Stage (2-10 Buffer: 50
hours): Phosphate Buffer, pH
6.0

Methylprednisolone Tablet Refer to USP

Methylprednisolone Acetate Injectable Suspension IV (Flow- 0.55 % SDS

Through Cell-
Open system)

Methyltestosterone Capsule Refer to USP

Methyltestosterone Tablet II (Paddle) 50 Water 900

Metoclopramide HCl Tablet Refer to USP

Metoclopramide HCl Tablet (Orally I (Basket) 50 Water 900

Disintegrating)

Metolazone Tablet II (Paddle) 75 2% SLS in 0.05 M Sodium 900

Phosphate Buffer, pH 7.5

Metoprolol Succinate Tablet (Extended Refer to USP

Release)

Metoprolol Tartrate Tablet Refer to USP

Metronidazole Capsule I (Basket) 100 0.1 N HCl 900

Metronidazole Tablet Refer to USP

Metronidazole Capsule Refer to USP

Metyrosine Capsule Refer to USP

Miconazole Tablet (Buccal) I (Basket) 60 0.5% SDS (Sodium 1000

dodecylsulfate) in water-pH
adjusted to 6.5 ± 0.5

Miconazole Nitrate Suppository (Vaginal) I (Basket) 100 0.45% SLS in water 900

Midodrine HCl Tablet II (Paddle) 50 0.1 N HCl 900

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Drug Name Dosage Form USP Apparatus Speed (RPMs) Medium Volume (

Midostaurin Capsule II (Paddle) 50 Tier 1:Deionized water with 900

0.5% Polysorbate 20; Tier 2:
Deionized water with 0.5%
Polysorbate 20 containing
pepsin

Mifepristone Tablet II (Paddle) 75 0.01 N HCl 900

Mifepristone [300 mg] Tablet II (Paddle) 50 pH 1.8 KCl Buffer 900

Miglitol Tablet II (Paddle) 75 Water 900

Miglustat Capsule I (Basket) 100 0.1 N HCl 1000

Milnacipran HCl Tablet II (Paddle) 50 0.1 N HCl 900

Miltefosine Capsule II (Paddle) 50 0.1 N HCl 750

Minocycline HCl Capsule (Extended I (Basket- 10 100 0.1 N HCl 900

Release) mesh)

Minocycline HCl ER Tablets I (Basket) 100 0.1 N HCl 900

Minocycline HCl Capsule Refer to USP

Minocycline HCl Tablet Refer to USP

Minocycline HCl (135 mg and 105 Tablet (Extended I (Basket) 100 pH 2.1 Buffer (Degassed) 900
mg) Release)

Minoxidil Tablet Refer to USP

Mirabegron Tablet (Extended I (Basket) 100 Phosphate Buffer, pH 6.8 900

Release)

Mirtazapine Tablet II (Paddle) 50 0.1 N HCl 900

Mirtazapine Tablet (Orally II (Paddle) 50 0.1 N HCl 900

Disintegrating (ODT))

Misoprostol Tablet II (Paddle) 50 Water (deaerated) 500

Mitotane Tablet Refer to USP

Modafinil Tablet II (Paddle) 50 0.1 N HCl 900

Moexipril HCl Tablet II (Paddle) 50 Water (deaerated) 900

Molindone HCl Tablet Refer to USP

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Drug Name Dosage Form USP Apparatus Speed (RPMs) Medium Volume (

Montelukast Granule I (Basket) (100 50 0.5% w/v SDS in Water 900

mesh)

Montelukast Sodium Tablet (Chewable) II (Paddle) 50 0.5% SDS in water 900

Montelukast Sodium Tablet II (Paddle) 50 0.5% SDS in water 900

Morphine Sulfate Capsule (Extended Refer to USP

Release)

Morphine Sulfate Tablet (Extended I (Basket) 100 Simulated Gastric Fluid [SGF] 900
Release) without enzyme

Morphine Sulfate Tablet II (Paddle) 50 Deionized Water 900

Morphine Sulfate (AB) Tablet (Extended I (Basket) 50 Water (deaerated) 900

Release)

Morphine Sulfate (AB2) Capsule (Extended II (Paddle) 50 Phosphate Buffer, pH 6.8 900
Release)

Morphine Sulfate (BC) Tablet (Extended I (Basket) 100 Water 500

Release)

Morphine Sulfate/Naltrexone HCl Capsule (Extended II (Paddle) 50 Acid stage: 0.1 N HCl; Buffer Acid stag
Release) stage: 0.05 Phosphate Buffer, Buffer sta
pH 7.5

Moxifloxacin Tablet II (Paddle) 50 0.1 N HCl 900

Mycophenolate Mofetil Suspension II (Paddle) 40 0.1 N HCl 900

Mycophenolate Mofetil Capsule II (Paddle) 40 0.1 N HCl 900

Mycophenolate Mofetil Tablet II (Paddle) 50 0.1 N HCl 900

Mycophenolic acid Tablet (Delayed II (Paddle) 50 Acid Stage: 0.1 N HCl; Buffer 750 (Acid
Release) Stage: Buffer Solution, pH 6.8 (Buffer)
(After initial 120 mins., 250 mL
of 0.2 M sodium phosphate
solution is added to acid stage
medium. The pH of the mixture
is adjusted to 6.8 using 0.2 M
sodium phosphate, 2 N sodium
hydroxide, or concentrated HCl
acid solution if necessary.)

Nabilone Capsule II (Paddle) 50 0.1% Tween 80 solution 1000

Nabumetone Tablet Refer to USP

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Drug Name Dosage Form USP Apparatus Speed (RPMs) Medium Volume (

Nadolol Tablet Refer to USP

Naldemedine Tablet II (Paddle) 50 Mixture of pH 6.8 phosphate 500

buffer [25 mM disodium
hydrogen phosphate] solution
and water (1:1)

Naloxegol Oxalate Tablet II (Paddle) 50 0.1 N HCl 500

Naltrexone Injectable Suspension Phosphate buffered saline with

0.02% Tween 20 and 0.02%
Sodium azide, pH 7.4 (final
osmolality should be 270 ± 20
mOsm), or any other
appropriate medium, at 37°C.
Develop an in vitro release
method using USP IV (Flow-
Through Cell), and, if
applicable, Apparatus II
(Paddle) or any other
appropriate method, for
comparative evaluation by the
Agency

Naltrexone HCl Tablet Refer to USP

Naltrexone HCl / Oxycodone HCl Capsule (Extended Develop a dissolution method

Release)

Naltrexone HCl/Bupropion HCl Tablet (Extended II (Paddle) 50 Water (degassed) 900

Release)

Naproxen Suspension Develop a dissolution method

Naproxen Tablet Refer to USP

Naproxen Tablet (Delayed Refer to USP

Release)

Naproxen Sodium Tablet Refer to USP

Naproxen Sodium Capsule II (Paddle) 75 Sodium Phosphate Buffer, pH 900

7.4 ± 0.05

Naproxen Sodium Tablet (Extended II (Paddle) 50 Phosphate Buffer, pH 7.5 900

Release)

Naproxen Tablet II (Paddle) 75 0.1M Sodium Phosphate buffer, 900

Sodium/Diphenhydramine HCl pH 7.4 (deaerated)

Naproxen Tablet II (Paddle) 75 0.1M Sodium Phosphate Buffer, 900

Sodium/Diphenhydramine HCl pH 7.4

Naproxen Sodium/Sumatriptan Tablet I (Basket) 75 Phosphate Buffer, pH 6.8 900

Succinate

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Drug Name Dosage Form USP Apparatus Speed (RPMs) Medium Volume (

Naproxen/Esomeprazole Tablet (Delayed II (Paddle) with Naproxen::50 rpm Naproxen:: Acid Stage: 0.1M Naproxen
Magnesium Release) sinkers Esomeprazole::75 HCl; Buffer Stage: 0.05M Stage: 10
rpm Phosphate buffer, pH 6.8. Stage: 10
Sampling for Acid stage: Esomepr
Transfer the un-dissolved tablet
& sinker to the vessel
containing the buffer stage
medium. Add, 10 mL of 10 M
NaOH to each vessel of the
remaining acid stage medium.
Continue rotation at 100 rpm for
30 minutes, withdraw aliquot
and analyze. Esomeprazole
(second set of tablets)(without
pre-exposure to acid stage)::
0.05M Phosphate buffer, pH 7.4

Naratriptan HCl Tablet Refer to USP

Nateglinide Tablet II (Paddle) 50 0.01 N HCl with 0.5% (w/v) SLS 1000

Nebivolol HCl Tablet II (Paddle) 50 0.01 N HCl 900

Nebivolol/Valsartan Tablet I (Basket) 100 67 mM Phosphate Buffer pH 900

6.8 with 0.5% SDS

Nefazodone HCl Tablet II (Paddle) 50 0.1 N HCl 900

Nelfinavir Mesylate Tablet II (Paddle) 50 0.1 N HCl 900

Nelfinavir Mesylate Powder for Suspension II (Paddle) 50 0.1 N HCl 900

Neomycin Sulfate Tablet II (Paddle) 50 0.05 M Phosphate Buffer, pH 900

6.8

Nepafenac Ophthalmic Develop a method to

Suspension characterize in vitro release

Netupitant/Palonosetron HCl Capsule II (Paddle) Netupitant:100; Netupitant: 0.07M Phosphate Netupitan

Palonosetron: 75 buffer pH 6.8 containing 1% Palonose
sodium SDS ; Palonosetron:
0.01 N HCl

Nevirapine Tablet (Extended I (Basket) 75 0.04 M Sodium phosphate 900

Release) buffer pH 6.8 containing 2%
sodium lauryl sulfate

Nevirapine Suspension II (Paddle) 25 0.1 N HCl 900

Nevirapine Tablet Refer to USP

Niacin Tablet (Extended I (Basket) 100 Water 900

Release)

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Drug Name Dosage Form USP Apparatus Speed (RPMs) Medium Volume (

Niacin/Simvastatin Tablet (Extended Niacin: I (40 100 Niacin: Water; Simvastatin: 0.5 900
Release) mesh rotating % SDS in 0.01 M Sodium
Basket); Phosphate, pH 7.0
Simvastain: I
(10 mesh
rotating Basket)

Nicardipine HCl Capsule II (Paddle) 50 0.033 M Citric Acid Buffer, pH 900

4.5

Nicardipine HCl Capsule (Extended II (Paddle) 50 0.1 N HCl 1000

Release)

Nicotine Film, Transdermal Refer to USP

(Extended Release)

Nicotine Polacrilex Chewing Gum Chewing 60 cycles (chews) Phosphate Buffer, pH 7.4 or or 20
Machine as per minute any other appropriate buffer
desribed in and conditions
European
Pharmacopoeia
(2.9.25)

Nicotine Polacrilex Lozenge (Mini) III 20 dpm Phosphate buffer pH 7.4 250
(Reciprocating
Cylinder)

Nicotine Polacrilex Lozenge I (Basket) 100 Phosphate Buffer, pH 7.4 900

Nifedipine Capsule Refer to USP

Nifedipine Tablet (Extended Refer to USP

Release)

Nilotinib Hydrochloride Capsule I (Basket) 100 0.1 N HCl 1000

Monohydrate

Nilutamide Tablet Develop a dissolution method

Nimodipine Capsule II (Paddle) 50 0.5% SDS in water 900

Nintedanib Esylate Capsule II (Paddle) with 100 0.1 N HCl 900

sinker

Niraparib Capsule II (Paddle) with 50 Tier 1: 0.08M Sodium Acetate 900

sinker Buffer, pH 4.0; Tier 2: 0.08M
Sodium Acetate Buffer, pH 4.0
containing pepsin (750,000
units/L)

Nisoldipine Tablet (Extended II (Paddle) with 50 HCl with SLS (32.5 ± 0.1 g 900
Release) option to use a Sodium Lauryl Sulfate in 6489
sinker mL of purified water containing
17.0 mL HCl, pH adjusted to
1.20 ± 0.05 with HCl)

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Drug Name Dosage Form USP Apparatus Speed (RPMs) Medium Volume (

Nitazoxanide Oral Suspension II (Paddle 100 Phosphate buffer at pH 7.5 with 900
6% hexadecyltrimethyl
ammonium bromide, bath
temperature at 25ºC

Nitazoxanide Tablet II (Paddle) 75 Phosphate buffer at pH 7.5 with 900

6% hexadecyltrimethyl
ammonium bromide, bath
temperature at 25ºC

Nitisinone Capsule II (Paddle) with 50 Phosphate Buffer, pH 6.8 1000

sinker

Nitisinone Tablet II (Paddle) 50 Phosphate Buffer, pH 6.8 2 mg tabl

mL; 5 mg
mg tablet

Nitisinone Suspension II (Paddle) 50 pH 1.2 HCl Buffer (degassed) 1000

Nitrofurantoin Capsule Refer to USP

Nitrofurantoin Suspension II (Paddle) 50 Phosphate Buffer, pH 7.2 900

Nitroglycerin Tablet (Sublingual) II (Paddle) 50 Phosphate Buffer, pH 6.5 500

Nitroglycerin Film, Modified USP 100 Deionized Water at 32º C 900

Transdermal (Extended Type V (Paddle-
Release) over-disk)

Nizatidine Capsule Refer to USP

Norethindrone Tablet Refer to USP

Norethindrone Acetate Tablet Refer to USP

Nortriptyline HCl Capsule Refer to USP

Nystatin Tablet II (Paddle) 75 Water with 0.1% SLS 900

Nystatin Oral Suspension II (Paddle) 25, 50 and 75 0.1 % and 0.2% SLS in water 900

Obeticholic Acid Tablet II (Paddle) 75 0.08% polysorbate 80 in 50mM 900

sodium phosphate dibasic
buffer, pH 6.8

Octreotide Injection Injectable (Extended Develop a dissolution method

Release) using USP IV (Flow-Through
Cell), and, if applicable,
Apparatus II (Paddle) or any
other appropriate method, for
comparative evaluation by the
Agency

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Drug Name Dosage Form USP Apparatus Speed (RPMs) Medium Volume (

Ofloxacin Tablet I (Basket) 100 0.1 N HCl 900

Olanzapine Tablet Refer to USP

Olanzapine Tablet (Orally Refer to USP

Disintegrating)

Olanzapine Pamoate For Intramuscular IV (Flow through Flow @ 3 mL/min 1% SLS in pH 6.8 Phosphate use Open
Suspension (Extended cell), 22.6 mm Buffer
Release) cell

Olaparib Capsule II (Paddle) 100 1% Polysorbate 80 in Water 1000

Olmesartan Medoxomil Tablet Refer to USP

Olsalazine Sodium Capsule I (Basket) 100 Phosphate Buffer, pH 7.5 900

Ombitasvir/ Paritaprevir/ Ritonavir Tablet II (Paddle) 75 Ombitasvir, paritaprevir, 900

and Dasabuvir Sodium ritonavir: 0.05 M sodium
phosphate buffer, pH 6.8 with
0.3% polyoxyethylene 10 lauryl
ether; Dasabuvir sodium: 0.05
M Sodium Phosphate buffer,
pH 6.8 with 15 mM cetyl
triethylammonium bromide
(CTAB)

Ombitasvir/Paritaprevir/Ritonavir Tablet II (Paddle) with 75 0.05M Sodium Phosphate 900

sinker Buffer, pH 6.8 with 0.3% (w/v)
Polyoxyethylene 10 Lauryl
Ether (POE10LE)

Omega-3-Acid Ethyl Esters Capsule Develop an in vitro release

method using USP IV (Flow-
Through Cell), and, if
applicable, Apparatus II
(Paddle) or any other
appropriate pharmacopoeial
apparatus, for comparative
evaluation by the Agency.

Omeprazole Capsule (Delayed Refer to USP

Release)

Omeprazole OTC Tablet (Delayed II (Paddle) 100 Tablets are pre-exposed to 750 Acid stag
Release) ml of 0.1M HCL for 2 hrs and Buffer sta
then 250 ml of 0.2M Na3PO4 is
added to the medium to give
1000 ml with pH 6.8

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Drug Name Dosage Form USP Apparatus Speed (RPMs) Medium Volume (

Omeprazole (Orally Disintegrating) OTC Tablet (Delayed II (Paddle) 100 Tablets are pre-exposed to 500 Acid stag
Release) ml of 0.1M HCL for 2 hrs and Buffer sta
then 400 ml of 0.235M
Na2HP04 is added to the
medium. Adjust if necessary
with 2 N HCI or 2 N NaOH to a
pH of 6.8

Omeprazole Magnesium For suspension II (Paddle) 100 Pre-exposed to 300 mL of 0.1M Acid stag
(Delayed Release) HCl for 2 hrs and then 700 mL Buffer sta
of 0.086 M Na2HPO4 is added
to the medium to give 1000 mL
with pH 6.8

Omeprazole Magnesium OTC Tablet (Delayed II (Paddle) 100 Tablets are pre-exposed to 300 300 ml fo
Release) mL of 0.1M HCL for 2 hrs and stage; 10
then 700 mL of 0.086 M the buffer
Na2HPO4 is added to the
medium containing the capsule
to give 1000 mL with pH 6.8

Omeprazole Sodium Bicarbonate Powder for suspension II (Paddle) 50 0.25 mM Sodium Phosphate 900
(Immediate Release) Buffer, pH 7.4

Omeprazole Sodium Bicarbonate Capsule II (Paddle) 75 Phosphate Buffer, pH 7.4 900

Ondansetron Tablet (Orally Refer to USP

Disintegrating)

Ondansetron Film (Oral) V (Paddle over 50 0.1 N HCl 900

Disk) with a
stainless steel
disk (120 mesh
screens)

Ondansetron HCl Tablet II (Paddle) 50 Water (deaerated) 500

Orlistat Capsule II (Paddle) 75 3% SLS in 0.5% Sodium 900

Chloride, pH 6.0

Orphenadrine Citrate Tablet (Extended Refer to USP

Release)

Oseltamivir Phosphate Capsule II (Paddle) 50 0.1 N HCl 900

Oseltamivir Phosphate Oral Suspension II (Paddle) 25 0.1 N HCl 900

Osimertinib Mesylate Tablet II (Paddle) 50 0.2 % NaCl solution in water 900

[adjust to pH 1.3]

Ospemifene Tablet II (Paddle) 50 2% Sodium Dodecyl Sulfate 900

(SDS) in Water

Oxaprozin Tablet Refer to USP

Oxcarbazepine Suspension II (Paddle) 75 1% SDS in water 900

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Drug Name Dosage Form USP Apparatus Speed (RPMs) Medium Volume (

Oxcarbazepine Tablet (Extended II (Paddle) with 75 1.0% SDS in Deionized Water 900
Release) sinker (degassed)

Oxcarbazepine (150 mg) Tablet II (Paddle) 60 0.3% SDS in water 900

Oxcarbazepine (300 mg) Tablet II (Paddle) 60 0.6% SDS in water 900

Oxcarbazepine (600 mg) Tablet II (Paddle) 60 1% SDS in water 900

Oxybutynin Trans-dermal Paddle over 50 Phosphate Buffer, pH 4.5 @ 900

Disk (Apparatus 32oC
5)

Oxybutynin Chloride Tablet (Extended Refer to USP

Release)

Oxycodone Capsule (Extended I (Basket) 100 22 mM Sodium Acetate buffer, 900

Release) pH 4.5 with 0.03% Tween 20

Oxycodone HCl Capsule II (Paddle) 50 0.1 N HCl 500

Oxycodone HCl Tablet (Extended Refer to USP

Release)

Oxycodone HCl Tablet Refer to USP

Oxycodone HCl/ Naloxone HCl Tablet (Extended II (Paddle) 50 Simulated Gastric Fluid [SGF, 900
Release) pH 1.2] without enzyme

Oxymorphone HCl Tablets II (Paddle) 50 0.1 N HCl 900

Oxymorphone HCl Tablet (Extended II (Paddle) with 50 45 mM Phosphate Buffer, pH 900

Release) sinker 4.5

Palbociclib Capsule II (Paddle) with 50 0.1 N HCl 900

sinker

Paliperidone Tablet (Extended II (Paddle) 50 Modified SGF, pH 1.0 [NaCl 500

Release) (0.2% w/w) in 0.0825N HCl]

Paliperidone Palmitate Intramuscular II (Paddle) 50 0.489% (w/v) Polysorbate 20 in 900

Suspension (Extended 0.001 N HCl @25.0 °C.
Release)

Paliperidone Palmitate [3-month Intramuscular II (Paddle) 50 0.489% (w/v) Polysorbate 20 in 900

injection] Suspension (Extended 0.001 N HCl @25.0 °C.
Release)

Palonosetron HCl Capsule II (Paddle) 75 0.1 N HCl 500

Pancrelipase Capsule (Delayed Refer to USP

Release)

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Drug Name Dosage Form USP Apparatus Speed (RPMs) Medium Volume (

Pancrelipase Tablet II (Paddle) 50 Phosphate Buffer, pH 4.5 900

Panobinostat Lactate Capsule I (Basket) 100 0.01 N HCl 900

Pantoprazole Sodium Delayed Release II (Paddle) 100 Acid Stage: 0.1 N Hydrochloric Acid stag
Granules for Oral Acid; Buffer Stage: 0.05 M Buffer sta
Suspension Tribasic Sodium Phosphate
(Add 250 mL of 0.2 mM
Tribasic Sodium Phosphate
after completion of acid stage);
pH 6.8 (Method B)

Pantoprazole Sodium Tablet (Delayed Refer to USP

Release)

Paricalcitol Capsule I (Basket) 100 4 mg/mL (0.4%) 500

Lauryldimethylamine N-oxide
(LDAO)

Paromomycin Sulfate Capsule I (Basket) 50 0.05 M Phosphate Buffer, pH 900

6.8

Paroxetine Tablet (Extended Refer to USP

Release)

Paroxetine HCl Tablet Refer to USP

Paroxetine HCl Suspension II (Paddle) 100 SGF without enzyme 900

Paroxetine Mesylate Tablet II (Paddle) 60 Simulated Gastric Fluid (SGF) 900

without enzymes

Paroxetine Mesylate Capsule II (Paddle) with 75 Simulated Gastric Fluid without 900
wire sinker enzyme , pH 1.2+0.05

Pazopanib HCl Tablet II (Paddle) 75 50 mM Sodium Acetate buffer, 900

pH 4.5, containing 0.75% SDS

Pemoline Tablet II (Paddle) 75 Water (deaerated) 900

Penbutolol Sulfate Tablet Refer to USP

Penicillamine Capsule Refer to USP

Penicillin V Tablet Refer to USP

Penicillin V Potassium Tablet Refer to USP

Pentosan Polysulfate Sodium Capsule I (Basket) 50 Water 900

Pentoxifylline Tablet (Extended Refer to USP

Release)

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Drug Name Dosage Form USP Apparatus Speed (RPMs) Medium Volume (

Perampanel Suspension II (Paddle) 50 0.1 N HCl 900 [890

HCl + 10
perampa
suspensi

Perampanel Tablet II (Paddle) 50 0.1 N HCl 900

Pergolide Mesylate Tablet II (Paddle) 50 Simulated gastric fluid TS with 500

cysteine without enzymes

Perindopril Erbumine Tablet II (Paddle) 50 0.1 N HCl 900

Perphenazine Tablet Refer to USP

Phendimetrazine Tartrate Capsule Refer to USP

Phendimetrazine Tartrate Capsule (Extended II (Paddle) 50 1 hour - SGF w/o Enzymes; 900
Release) after 1 hour - SIF w/o Enzymes

Phendimetrazine Tartrate Tablet Refer to USP

Phenelzine Sulfate Tablet II (Paddle) 50 Simulated Gastric Fluid without 900

enzymes, pH 1.2

Phenoxybenzamine HCl Capsule Refer to USP

Phentermine HCl Tablet II (Paddle) 50 Water 900

Phentermine HCl Capsule Refer to USP (provide

individual unit data).

Phentermine HCl Tablet Refer to USP

Phentermine HCl Tablet (Orally II (Paddle) 50 Water 500 mL (

Disintegrating) 900 mL (
37.5 mg)

Phentermine HCl/Topiramate Capsule (Extended I (Basket) 100 Water (deionized and 750
Release) degassed)

Phenytoin Suspension Refer to USP

Phenytoin Tablet (Chewable) Refer to USP

Phenytoin Sodium Capsule Refer to USP

Phytonadione Tablet Develop a dissolution method

Pilocarpine HCl Tablet II (Paddle) 50 0.1 N HCl 500

Pimavanserin Tartrate Tablet I (Basket) 100 0.1 N HCl 900

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Drug Name Dosage Form USP Apparatus Speed (RPMs) Medium Volume (

Pimozide Tablet Refer to USP

Pindolol Tablet Refer to USP (provide

individual unit data).

Pioglitazone HCl Tablet II (Paddle) 75 HCl-0.3 M KCl Buffer, pH 2.0 900

Pirfenidone Capsule II (Paddle) with 50 Water (Deionized) 1000

sinker

Pirfenidone Tablet II (Paddle) 50 Water 1000

Piroxicam Capsule Refer to USP

Pitavastatin Calcium Tablet I (Basket) 35 0.05 M Phosphate Buffer, pH 900

6.8

Pomalidomide Capsule II (Paddle) 50 0.1 N HCl 900

Ponatinib HCl Tablet I (Basket) 50 pH 2.1, KCl/HCl buffer 900

(degassed)

Posaconazole Tablet (Delayed II (Paddle) 75 Acid Stage: 0.01 N HCl: Buffer Acid Stag
Release) Stage: 50 mM phosphate Buffer Sta
buffer, pH 6.8 with 0.37 % mL
Polysorbate 80 (after 120
minutes, to the acid stage, add
250 mL of 0.2M Phosphate
Buffer, 1.46% Polysorbate 80)

Posaconazole Oral Suspension II (Paddle) 25 0.3% SLS 900

Potassium Chloride Tablet (Extended Refer to USP

Release)

Potassium Chloride Capsule (Extended Refer to USP

Release)

Potassium Citrate Tablet Refer to USP

Pramipexole Dihydrochloride Tablet (Extended I (Basket) 100 0.05 M phosphate buffer, pH 500
Release) 6.8

Pramipexole Dihydrochloride Tablet II (Paddle) 50 0.023 M Citrate/0.155 M 500

Phosphate Buffer, pH 6.8

Prasugrel HCl Tablet II (Paddle) 75 Citrate-Phosphate buffer 900

(0.023M Citric acid+0.026M
Sodium Phosphate, Dibasic),
pH 4.0

Pravastatin Sodium Tablet II (Paddle) 50 Water (deaerated) 900

Praziquantel Tablet Refer to USP

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Drug Name Dosage Form USP Apparatus Speed (RPMs) Medium Volume (

Prednisolone Tablet Refer to USP

Prednisolone Acetate Ophthalmic Develop an in vitro release

Suspension method

Prednisolone Sodium Phosphate Tablet (Orally II (Paddle) 50 22 mM Sodium Acetate Buffer, 500
Disintegrating) pH 4.5

Prednisone Tablet (Delayed II (Paddle) with 100 Water 500

Release) sinker

Prednisone Tablet Refer to USP

Pregabalin Capsule II (Paddle) with 50 0.06 N HCl 900

sinker

Pregabalin Tablet (Extended II (Paddle) 50 0.06 M HCl 900

Release)

Primaquine Phosphate Tablet Refer to USP

Primidone Tablet Refer to USP

Procarbazine HCl Capsules II (Paddle) 50 Water 900

Prochlorperazine Rectal Suppository I (Suppository, 100 0.1 N HCl at 38° C 900

dissolution
baskets,
palmieri type)

Progesterone Capsule Develop a quantitative rupture

test

Progesterone Vaginal Insert II (Paddle) 50 0.25% sodium dodecyl sulfate 900

(SDS) in DI water

Promethazine HCl Tablet Refer to USP

Promethazine HCl Rectal Suppository Develop a method to

characterize in vitro release

Propafenone HCl Tablet Refer to USP

Propafenone HCl Capsule (Extended Refer to USP

Release)

Propranolol HCl Capsule (Extended Refer to USP

Release)

Propranolol HCl Tablet Refer to USP

Propylthiouracil Tablet Refer to USP

Protriptyline HCl Tablet Refer to USP

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Drug Name Dosage Form USP Apparatus Speed (RPMs) Medium Volume (

Pseudoephedrine HCl Tablet (Extended Refer to USP

Release)

Pseudoephedrine HCl/Triprolidine Tablet Refer to USP

HCl

Pyrazinamide Tablet Refer to USP

Pyridostigmine Bromide Tablet Refer to USP

Pyridostigmine Bromide Tablet (Extended II (Paddle) 50 Water 900

Release)

Pyrimethamine Tablet Refer to USP

Quetiapine Fumarate Tablet II (Paddle) 50 Water (deaerated) 900

Quetiapine Fumarate Tablet (Extended I (Basket, with 200 0.05M citric acid and 0.09 N 900 [solu
Release) 20 mesh) NaOH (pH 4.8) [solution A]. At 1000 [fina
5 hrs, pH adjusted to 6.6 by
addition of 100 mL of 0.05M
dibasic sodium phosphate and
0.46N NaOH [solution B]

Quinapril HCl Tablet Refer to USP

Quinine Sulfate Capsule Refer to USP

Rabeprazole Sodium Tablet (Delayed II (Paddle) 100 700 mL 0.1 N HCl (Acid stage), Acid stag
Release) after two hours add 300 mL of Buffer sta
0.6 M Tris buffer; adjust to pH
8.0 (Buffer stage) with 2 N HCl
or 2 N NaOH . Stabilize the
samples with the addition of 0.5
N NaOH

Rabeprazole Sodium Capsule (Delayed II (Paddle) Acid Stage: 75 rpm; Acid Stage:0.1 N HCl; Buffer Acid Stag
Release) Buffer Stage: 60 Stage: 0.05 M Phosphate Buffer Sta
rpm Buffer, pH 6.8 (After Acid
Stage, add 250 mL of 0.2 mol/L
trisodium phosphate solution).

Raloxifene HCl Tablet II (Paddle) 50 0.1% Polysorbate 80 in water 1000

Raltegravir Potassium Tablet II (Paddle) with 100 Water (Deaerated) 900

option to use a
sinker

Raltegravir Potassium Tablet (Chewable) II (Paddle) 50 Water(deareated) 900

Ramelteon Tablet II (Paddle) 50 Water 900

Ramipril Capsule II (Paddle) 50 0.1 N HCl 500

Ramipril Tablet II (Paddle) 50 0.1 N HCl 500

Ranitidine HCl Tablet Refer to USP

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Drug Name Dosage Form USP Apparatus Speed (RPMs) Medium Volume (

Ranitidine HCl Capsule II (Paddle) 50 Water (deaerated) 900

Ranitidine HCl Tablet (Effervescent) Develop a dissolution method

Ranolazine Tablet (Extended Develop a dissolution method

Release)

Rasagiline Mesylate Tablet II (Paddle) 50 0.1 N HCl 500

Regorafenib Tablet II (Paddle) 75 Acetate Buffer pH 4.5 with 900

0.1% Sodium Dodecyl Sulfate
(SDS)

Repaglinide Tablet Refer to USP

Ribavirin Tablet II (Paddle) 50 Water (deaerated) 900

Ribavirin Capsule I (Basket) 100 Water (deaerated) 900

Ribociclib Tablet II (Paddle) 50 0.01N HCl (Degassed) 900

Rifabutin Capsule Refer to USP

Rifampin Capsule Refer to USP

Rifapentine Tablet II (Paddle) 50 0.8% SLS in Phosphate Buffer, 900

pH 7.0

Rifaximin (200 mg) Tablet II (Paddle) 75 0.1M sodium phosphate buffer 1000
pH 7.4 containing 0.45%
Sodium Lauryl Sulfate

Rifaximin (550 mg) Tablet II (Paddle) 75 0.1M sodium phosphate buffer 1000
pH 7.4 containing 0.8% Sodium
Lauryl Sulfate

Rilpivirine HCl Tablet II (Paddle) 75 0.5% Polysorbate 20 in 0.01N 900

HCl (pH=2.0)

Riluzole Tablet II (Paddle) 50 0.1 N HCl 900

Rimantadine HCl Tablet II (Paddle) 50 Water 900

Rimexolone Ophthalmic Develop a method to

Suspension characterize in vitro release

Riociguat Tablet II (Paddle) 75 pH 6.8 Phosphate Buffer with 900

0.1% Sodium Lauryl Sulfate
[SLS]

Risedronate Sodium Tablet (Delayed II (Paddle) 75 Acid stage: 0.1 N HCl; Buffer Acid stag
Release) stage: Phosphate buffer, pH 6.8 Buffer sta

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Drug Name Dosage Form USP Apparatus Speed (RPMs) Medium Volume (

Risedronate Sodium Tablet Refer to USP

Risedronate Sodium/Calcium Tablet (Copackaged) For Risedronate Tablets: Refer

Carbonate to USP; For Calcium Carbonate
Tablets: Refer to USP.

Risperidone Injectable Develop a dissolution method

using USP IV (Flow-Through
Cell), and, if applicable,
Apparatus II (Paddle) or any
other appropriate method, for
comparative evaluation by the
Agency

Risperidone Tablet II (Paddle) 50 0.1 N HCl 500

Risperidone Tablet (Orally II (Paddle) 50 0.1 N HCl 500

Disintegrating)

Ritonavir Powder I (Basket -100 100 0.1 N HCl 900

mesh)

Ritonavir Tablet Refer to USP

Ritonavir Capsule Refer to USP

Rivaroxaban (10 mg) Tablet II (Paddle) 75 Acetate Buffer pH 4.5, 0.2% 900
sodium dodecyl sulfate (SDS)

Rivaroxaban (15 and 20 mg) Tablet II (Paddle) 75 Acetate Buffer pH 4.5, 0.4% 900
SDS

Rivaroxaban (2.5 mg) Tablet II (Paddle) 75 Acetate Buffer pH 4.5 900

Rivastigmine Film, Transdermal Modified USP 50 0. 9 % NaCl at 32º C 500

Type VI
(cylinder)

Rivastigmine Tartrate Capsule II (Paddle) 50 Water (deaerated) 500

Rizatriptan Benzoate Tablet (Orally II (Paddle) 50 Water (deaerated) 900

Disintegrating)

Rizatriptan Benzoate Tablet II (Paddle) 50 Water (deaerated) 900

Roflumilast Tablet II (Paddle) 50 1.0% SDS (sodium dodecyl 1000

sulfate) in Phosphate Buffer, pH
6.8

Rolapitant HCl Tablet II (Paddle) 50 0.05 M Sodium Acetate buffer, 900

pH 4.0

Ropinirole HCl Tablet (Extended II (Paddle) 100 pH 4.0 Citrate-THAM Buffer 500
Release)

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Drug Name Dosage Form USP Apparatus Speed (RPMs) Medium Volume (

Ropinirole HCl Tablet Refer to USP

Rosiglitazone Maleate Tablet II (Paddle) 50 0.01M Acetate Buffer, pH 4.0 900

Rosuvastatin Calcium Tablet II (Paddle) 50 0.05 M Sodium Citrate Buffer 900

pH 6.6 ± 0.05

Rotigotine Transdermal Paddle over 50 Phosphate Buffer, pH 4.5 at 900

Disk (Apparatus 32°C
5)

Rucaparib Tablet II (Paddle) 75 0.01 N HCl 900

Rufinamide Suspension II (Paddle) 50 2.0% SDS (sodium dodecyl 900

sulfate) in water

Rufinamide Tablet Refer to USP

Ruxolitinib Phosphate Tablet II (Paddle) 75 0.1 N HCI 900

Sacubitril/Valsartan Tablet I (Basket) 75 Phosphate Buffer, pH 900

6.8[degassed]

Safinamide Mesylate Tablet II (Paddle) 100 0.1 N HCL with Sodium 900
Chloride [2% (wt/vol) solution],
pH 1.2

Sapropterin Dihydrochloride Powder for II (Paddle) 50 0.1 N HCl 900

Oral Solution

Sapropterin Dihydrochloride Tablet II (Paddle) 50 0.1 N HCl 900

Saquinavir Mesylate Tablet II (Paddle) 50 Citrate Buffer (pH 3.0) 900

Saquinavir Mesylate Capsule Refer to USP

Saxagliptin HCl Tablet II (Paddle) 50 0.1 N HCl 900

Scopolamine Transdermal Reciprocating Stroke depth: 2-3 Distilled Water 25 × 150

disk (Apparatus cm; 30-60 cycles tubes con
7) per minute mL

Secnidazole Granule I (Basket) 50 Phosphate Buffer, pH 6.8 900

Selegiline HCl Capsule Refer to USP

Selegiline (20 mg/20 cm2 and 30 Transdermal Paddle over 50 0.1 M Phosphate buffer, 500
mg/30 cm2) Disk (Apparatus monobasic, pH 5 at 32°C
5)

Selegiline (40 mg/40 cm2) Transdermal Rotating 50 0.1 M Phosphate buffer, 1000
Cylinder monobasic, pH 5 at 32°C
(Apparatus 6)

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Drug Name Dosage Form USP Apparatus Speed (RPMs) Medium Volume (

Selegiline HCl Tablet (Orally I (Basket) 50 Water 500

Disintegrating)

Selexipag Tablet II (Paddle) 50 Phosphate Buffer, pH 6.8 900

Sertraline HCl Tablet II (Paddle) 75 0.05 M Sodium Acetate Buffer, 900

pH 4.5

Sevelamer Carbonate Tablet Disintegration Testing in 0.1 N

HCl as per USP <701>

Sevelamer HCl Capsule Disintegration Testing in 0.1 N

HCl as per USP <701>

Sevelamer HCl Tablet Disintegration Testing in 0.1 N

HCl as per USP <701>

Sibutramine HCl Capsule II (Paddle) 50 0.05 M Acetate Buffer, pH 4.0 500

Sildenafil Citrate Tablet I (Basket) 100 0.01 N HCl 900

Sildenafil Citrate Suspension II (Paddle) 50 McIlvaine Buffer, pH 5.0 500

Silodosin Capsule II (Paddle) with 50 0.1 N HCl 900

sinker

Simeprevir Sodium Capsule II (Paddle) 75 0.05 M Phosphate Buffer, pH 900

6.8 with 1.0% polysorbate 20

Simvastatin Tablet (Orally II (Paddle) 75 0.15% SDS Buffer, pH 6.8 900

Disintegrating)

Simvastatin Suspension II (Paddle) 50 Phosphate Buffer, pH 7.0, with 900

0.14% sodium dodecyl sulfate
(SDS)

Simvastatin Tablet Refer to USP

Sirolimus Tablet Basket (20 120 0.4% SLS in water 500

mesh)

Sitagliptin Phosphate Tablet I (Basket) 100 Water 900

Sitagliptin Phosphate/Simvastatin Tablet II (Paddle) with 100 10 mM Sodium phosphate 900

stainless steel buffer containing 1% Tween 80
stationary with 50 µg/mL Butylated
quadrangular hydroxyanisole
hanging basket

Sodium Iodide I-123 Capsule I (Basket) 100 Water (deaerated) 500

Sodium Phenylbutyrate Powder for Oral II (Paddle) 75 Simulated Intestinal Fluid 900

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Drug Name Dosage Form USP Apparatus Speed (RPMs) Medium Volume (

Sodium Phosphate Dibasic Tablet II (Paddle) 100 Water (deionized) 900

Anhydrous/Sodium Phosphate
Monobasic Monohydrate

Sofosbuvir Tablet II (Paddle) 75 0.05 M Phosphate Buffer, pH 900

6.8

Sofosbuvir/Velpatasvir Tablet II (Paddle) 75 50 mM sodium acetate 900

buffer,pH 5.0, with 0.5% w/v
Cetyltrimethyl ammonium
bromide (CTAB)

Solifenacin Succinate Tablet II (Paddle) 50 Water 900

Sonidegib Phosphate Capsule II (Paddle) with 75 Tier 1: 0.1 M HCl with 1.0% Tier 1: 90
sinker SDS; Tier II: Stage 1: 850 mL Stage 1:
of 0.1 N HCl solution with Stage 2:
pepsin [250’000 units/L]. Stage
2: After 10 minutes add 50 mL
of 18% SDS in 0.1 N HCl

Sorafenib Tosylate Tablet II (Paddle) 75 0.1 M HCl with 1% SDS 900

Spironolactone Tablet Refer to USP

Stavudine Capsule Refer to USP

Succimer Capsule II (Paddle) 50 0.01 N Phosphoric Acid 900

Sucralfate Suspension II (Paddle) 75 0.1N HCl/0.067 M KCl, pH 1.0 900

Sucralfate Tablet II (Paddle) 75 0.1 N HCl/0.067 M KCl, pH 1.0 900

Sucroferric Oxyhydroxide Tablet (Chewable) II (Paddle) 50 0.1 N HCl 900

Sulfadiazine Tablet Refer to USP

Sulfamethoxazole/Trimethoprim Tablet Refer to USP

Sulfamethoxazole/Trimethoprim Suspension II (Paddle) 50 1 mL of 0.2 N HCl in water 900

Sulfasalazine Tablet Refer to USP

Sulfasalazine Tablet (Delayed Refer to USP

Release)

Sulfisoxazole Acetyl Oral Suspension II (Paddle) 30 1% SLS in 0.1N HCl 900

(Pediatric)

Sumatriptan Succinate Tablet II (Paddle) 30 0.01 N HCl 900

Sunitinib Malate Capsule II (Paddle) 50 0.1 N HCl 900

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Drug Name Dosage Form USP Apparatus Speed (RPMs) Medium Volume (

Suvorexant Tablet II (Paddle) with 75 0.4% Sodium Lauryl Sulfate in 900

sinker Water

Tacrolimus Capsule II (Paddle) 50 Hydroxypropyl Cellulose 900

Solution (1 in 20,000). Adjust to
pH 4.5 by Phosphoric Acid

Tacrolimus Tablet (Extended II (Paddle) 100 0.005% HPC in Water with 900
Release) 0.50% SLS adjusted to pH 4.5

Tadalafil Tablet II (Paddle) 50 0.5% Sodium Lauryl Sulfate 1000

Tamoxifen Citrate Tablet Refer to USP

Tamsulosin HCl Capsule II (Paddle) 100 0-2 hours: 0.003% polysorbate 500
80, pH 1.2 2-8 hours:
phosphate buffer, pH 7.2

Tapentadol HCl Tablet (Extended II (Paddle) with 100 0.05 M Phosphate Buffer of pH 900
Release) sinker 6.8, Simulated intestinal fluid
(without enzyme)

Tapentadol HCl Tablet I (Basket) 75 0.1 N HCl 900

Tasimelteon Capsule II (Paddle) with 50 0.1 N HCl 500

sinker

Tedizolid Phosphate Tablet II (Paddle) 60 0.05 M phosphate buffer pH 6.8 900

Telaprevir Tablet II (Paddle) 50 1% SLS in Water 900

Telbivudine Tablet II (Paddle) 50 0.1 N HCl 900

Telithromycin Tablet II (Paddle) 50 0.1 N HCl 900

Telmisartan Tablet Refer to USP

Temazepam Capsule Refer to USP

Temozolomide Capsule I (Basket) 100 Water 500 (for 5

ml (for ot
strengths

Tenofovir Alafenamide Fumarate Tablet II (Paddle) 75 50 mM Sodium Acetate buffer 500

pH 4.5

Tenofovir Disoproxil Fumarate Tablet II (Paddle) 50 0.1 N HCl 900

Tenofovir Disoproxil Fumarate Powder for Oral II (Paddle) 100 0.2% polysorbate 80 in 0.01 M 900
HCl

Terazosin HCl Tablet II (Paddle) 50 Water (deaerated) 900

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Drug Name Dosage Form USP Apparatus Speed (RPMs) Medium Volume (

Terazosin HCl Capsule II (Paddle) 50 Water (deaerated) 900

Terbinafine HCl Tablet II (Paddle) 50 Citrate Buffer, pH 3.0 adjusted 500

with HCl

Terconazole Suppository (Vaginal) I (with Palmieri 100 0.12 N HCl with 1% SLS 900
type basket)

Teriflunomide Tablet II (Paddle) 50 0.05 M Phosphate Buffer, pH 1000

6.8

Testosterone Buccal Tablet II (Paddle, may 60 1% sodium dodecyl sulfate in 1000

(Extended Release) use sinker) double distilled water

Testosterone Pellet Implant Develop a dissolution method

Testosterone Film, Transdermal V (Paddle over 50 0.1 M sodium chloride 900

(Extended Release) disk). Paddle 25 containing 2.5% (v/v) of Tween
mm above the 40 at 32 ± 0.5°C. Delivery
film on the disk. surface faces upwards towards
the media.

Tetrabenazine Tablet II (Paddle) 50 0.1 N HCl 900

Tetracycline HCl Capsule Refer to USP

Tetracycline HCl Tablet Refer to USP

Thalidomide Capsule II (Paddle) 100 1.5% (w/v) SLS (pH 3.0, adj w/ 900
HCl)

Theophylline Capsule (Extended Refer to USP 900

Release)

Theophylline (100 mg and 200 mg) Tablet (Extended II (Paddle) 50 SGF without Enzyme, pH 1.2 900
Release) during 1st hour. Phosphate
Buffer at pH 7.5 from end of
hour 1 through the duration of
testing

Theophylline (300 mg and 450 mg) Tablet (Extended II (Paddle) 50 SGF without Enzyme, pH 1.2 900
Release) during 1st hour. Phosphate
Buffer at pH 7.5 from end of
hour 1 through the duration of
testing

Theophylline (600 mg and 400 mg) Tablet (Extended I (Basket) 100 SGF without enzyme, pH 1.2 900
Release) during 1st hour. SIF without
enzyme from end of hour 1
through the duration of the
testing

Thioguanine Tablet Refer to USP

Tiagabine HCl Tablet II (Paddle) 50 Water 900

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Drug Name Dosage Form USP Apparatus Speed (RPMs) Medium Volume (

Ticagrelor Tablet II (Paddle) 75 0.2% w/v Polysorbate 80 in 900

water

Ticlopidine HCl Tablet II (Paddle) 50 Water (deaerated) 900

Timolol Maleate Tablet Refer to USP

Tinidazole Tablet I (Basket) 100 Water (Deaerated) 900

Tiopronin Tablet I (Basket) 100 0. 08N HCl containing 0.2% w/v 900
NaCl

Tipiracil HCl/Trifluridine Tablet II (Paddle) 50 0.1 N HCl 900

Tipranavir Capsule II (Paddle) 50 0.05 M phosphate buffer pH 6.8 900

Tizanidine HCl Capsule II (Paddle) 50 0.01 N HCl 500

Tizanidine HCl Tablet I (Basket) 100 0.1 N HCl 500

Tofacitinib Citrate Tablet (Extended II (Paddle) with 50 Phosphate Buffer, pH 6.8 900
Release) option to use a
sinker

Tofacitinib Citrate Tablet I (Basket) 100 0.1N HCl 900

Tolcapone Tablet Refer to USP

Tolterodine Tartrate Tablet II (Paddle) 50 SGF without enzymes, pH 1.2 900

Tolterodine Tartrate Capsule (Extended I (Basket) 100 Phosphate buffer (pH 6.8) 900
Release)

Tolvaptan Tablet II (Paddle) 50 0.22% Sodium Lauryl Sulfate 900

(SLS) in Water

Topiramate Capsule (Extended II (Paddle) 50 0.05 M Phosphate Buffer, pH 750

Release) 7.5

Topiramate Capsule (Sprinkle) II (Paddle) 50 Water (deaerated) 900

Topiramate Tablet II (Paddle) 50 Water (deaerated) 900

Topiramate Capsule (Extended I (Basket) 100 50 mM Tris buffer, pH 7.2 900

Release)

Topotecan HCl Capsule II (Paddle) 50 Acetate Buffer with 0.15% SDS, 500
pH 4.5

Toremifene Citrate Tablet II (Paddle) 50 0.02 N HCl 1000

Torsemide Tablet II (Paddle) 50 0.1 N HCl 900

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Drug Name Dosage Form USP Apparatus Speed (RPMs) Medium Volume (

Tramadol Capsule (Extended I (Basket) 100 Water (Deaerated ) 900

Release)

Tramadol HCl Tablet I (Basket) 100 0.1 N HCl 900

Tramadol HCl Tablet (Extended I (Basket) 75 0.1 N HCl 900

Release)

Trametinib Dimethyl Sulfoxide Tablet II (Paddle) 60 pH 4.5, 50 mM Sodium Acetate 500

with 0.75% Sodium Lauryl
Sulfate [SLS]

Trandolapril Tablet II (Paddle) 50 Water (deaerated) 500

Trandolapril/Verapamil HCl Tablet (Extended II (Paddle) 50 For Trandolapril: Water; For For Trand
Release) Verapamil: 0-1 hour Gastric 500; For
Fluid w/o Pepsin pH=1.2, 1-8 900
hour Intestinal Fluid w/o
Pancreatin

Tranexamic Acid Tablet II (Paddle 50 Water 900

Tranylcypromine Sulfate Tablet Refer to USP

Trazodone HCl Tablet Refer to USP

Trazodone HCl Tablet (Extended II (Paddle) 50 Water 900

Release)

Treprostinil Diolamine Tablet (Extended I (Basket) 100 0.05 M Phosphate Buffer, pH 500
Release) 6.8 (deaerated)

Tretinoin Capsule I (Basket) 100 0.5% solid 900

Lauryldimethylamine-oxide
(LDAO) in 0.05M Phosphate
Buffer, pH 7.8

Triamcinolone Acetonide Injectable Suspension Develop a dissolution method

using USP IV (Flow-Through
Cell), and, if applicable,
Apparatus II (Paddle) or any
other appropriate method, for
comparative evaluation by the
Agency

Triamcinolone Acetonide Intra-Articular, For II (Paddle) 75 0.3% SDS in 10 mM phosphate 1000

Suspension (Extended buffer, pH 7.2 + 0.02% sodium
Release) azide @35°C

Triamterene Capsule Refer to USP

Trientine HCl Capsule Refer to USP

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Drug Name Dosage Form USP Apparatus Speed (RPMs) Medium Volume (

Trimethoprim Tablet Refer to USP

Trimipramine Maleate Capsule I (Basket) 100 Water (deaerated) 1000

Triptorelin Pamoate Injectable Suspension II (Paddle) 200 Water-Methanol (95:5); 500

Reconstitute vial in 2 mL Water
for Injection, add to 500 mL
medium at 37°C

Triptorelin Pamoate For Intramuscular II (Paddle) 75 50 mL of methanol to 950 mL of 950

Suspension (Extended water
Release)

Trospium Chloride Tablet II (Paddle) 50 0.1 N HCl 1000

Trospium Chloride Capsule (Extended II (Paddle) with 50 0.1 N HCl, pH 1.1 for 2 hrs and 0-2 hrs: 7
Release) sinker then add 200 mL of 0.1 N After 2 hr
NaOH in 200 mM Phosphate
Buffer. Adjust pH to 7.5 using 2
N HCl and/or 2N NaOH

Ulipristal Acetate Tablet II (Paddle) 50 0.1 N HCl 900

Ursodiol Capsules Refer to USP

Ursodiol Tablet Refer to USP

Valacyclovir Hydrochloride Tablet II (Paddle) 50 0.1 N HCl 900

Valbenazine Capsule II (Paddle) with 50 Tier 1: 0.1N HCl; Tier 2: 0.1N 900
sinker HCl containing pepsin (750,000
units per 1000 mL)

Valganciclovir HCl Tablet Refer to USP

Valproic Acid Capsule Refer to USP

Valsartan Capsule II (Paddle) 50 0.067 M Phosphate Buffer, pH 1000

6.8

Valsartan Tablet Refer to USP

Vancomycin hydrochloride Capsule Refer to USP

Vandetanib Tablet II (Paddle) 50 pH 1.2 Buffer [0.05 M KCl in 1000

water, adjust the pH with HCl or
NaOH]

Vardenafil HCl Tablet II (Paddle) 50 0.1 N HCl 900

Vardenafil HCl Tablet (Orally II (Paddle) 50 0.1 N HCl 900

Disintegrating)

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Drug Name Dosage Form USP Apparatus Speed (RPMs) Medium Volume (

Varenicline Tartrate Tablet I (Basket) 100 0.01 N HCl 500

Vemurafenib Tablet II (Paddle) 75 1% 900

hexadecyltrimethylammonium
bromide (HTAB) in 0.05 M
Phosphate Buffer, pH 6.8

Venetoclax Tablet III 20 dpm Phosphate Buffer, pH 6.8 with 250

(Reciprocating 0.4% sodium dodecyl sulfate
Cylinder) (SDS) [3 small drops of
[Bottom Screen: antifoaming agent may be
200 mesh used]
stainless steel]

Venlafaxine HCl Tablet II (Paddle) 50 Water (deaerated) 900

Venlafaxine HCl Capsule (Extended I (Basket) 100 Water 900

Release)

Venlafaxine HCl Tablet (Extended II (Paddle) 50 Water (deaerated) 900

Release)

Verapamil HCl Capsule (Extended Refer to USP

Release)

Verapamil HCl Tablet (Extended Refer to USP

Release)

Verapamil HCl Tablet Refer to USP

Verteporfin Injectable Develop a method to

characterize in vitro release.

Vigabatrin Tablet II (Paddle) 50 Water 900

Vilazodone HCl Tablet II (Paddle) 60 0.1% v/v Glacial acetic acid 1000
solution (pH 3.1)

Vismodegib Capsule II (Paddle) 75 0.01 N HCl with 1.0% sodium 900

lauryl sulfate (SLS)

Vorapaxar Sulfate Tablet II (Paddle) 50 41 mM Na2HPO4, 1.5% Citric 900

Acid, pH 3.0 ± 0.5

Voriconazole Tablet II (Paddle) 50 0.1 N HCl 900

Voriconazole Suspension II (Paddle) 50 0.1 N HCl 900

Vorinostat Capsule II (Paddle) with 100 2% Tween 80 in Water 900

sinker

Vortioxetine HBr Tablet II (Paddle) 50 0.1 N HCl 900

Warfarin Sodium Tablet Refer to USP

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Drug Name Dosage Form USP Apparatus Speed (RPMs) Medium Volume (

Zafirlukast Tablet II (Paddle) 50 1% w/v Aqueous Sodium 1000

Dodecyl Sulfate

Zalcitabine Tablet Refer to USP 900

Zaleplon Capsule II (Paddle) 75 Deionized Water 900

Zidovudine Tablet Refer to USP

Zidovudine Capsule Refer to USP

Zileuton Tablet II (Paddle) 50 0.05 M SLS in water 900

Zileuton Tablet (Extended II (Paddle) with 75 0.1 M SDS (sodium dodecyl 900
Release) sinker sulfate) in water

Zinc Acetate Capsule II (Paddle) 50 0.1 N HCl 900

Ziprasidone HCl Capsule II (Paddle) 75 Tier I: 0.05 M Na phosphate 900

buffer, pH 7.5 + 2% SDS (w/w)
Tier II: 0.05 M Na phosphate
buffer, pH 7.5 (700ml) + 1%
pancreatin. After 15 min.
incubation, add 200 mL of
phosphate buffer containg 9%
SDS

Zolmitriptan Tablet II (Paddle) 50 0.1 N HCl 500

Zolmitriptan Tablet (Orally II (Paddle) 50 0.1 N HCl 500

Disintegrating)

Zolpidem Tartrate Tablet (Extended Refer to USP

Release)

Zolpidem Tartrate Tablet II (Paddle) 50 0.01 N HCl, pH 2.0 900

Zolpidem Tartrate (1.75 and 3.5 Tablet (Sublingual) II (Paddle) 50 Simulated intestinal fluid 500
mg) (without enzyme), pH 6.8,
(deaerated)

Zolpidem Tartrate (5 and 10 mg) Tablet (Sublingual) II (Paddle) 75 Phosphate Buffer, pH 6.8 900

Zonisamide Capsule II (Paddle) 50 Water (deaerated) 900

Showing 1 to 1,325 of 1,325 entries

Dissolution Methods Disclaimer ([Link])

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