WEST-COAST Q.C.
DEPARTMENT
FINISHED PRODUCT SPECIFICATION
PRODUCTNAME: AMBROXOL Spec. No. : WC/QC/SP/0550 Supersedes : NIL
HYDROCHLORIDE SYRUP 15 MG/5 ML
Strength: 15MG/ 5 ML Effective Date : 01/01/2022
Page No. : 1 of 1
Specification : SPECIFICATION Revised Date : -----
SR. NO. TESTS SPECIFICATION
1. Description Clear colorless liquid
2. pH 6.0 TO 8.0
3. Weight per ml Not less than 1.000 gm/ml
4. Deliverable volume Not less than 100.0 ml
5. Identification The principal spot in the chromatogram obtained
with the test solution is similar in position and
size to the principal spot in the chromatogram
obtained with the reference solution.
6. Microbial limit test
For total aerobic microbial count Not more than 1000 cfu/gm
For yeast & mold Not more than 100 cfu/gm
E.coli Absent
Salmonella Absent
Ps.aeruginosa Absent
S.aureus Absent
7. Impurities
unspecified impurities Not more than 0.10 %
Total impurities Not more than 0.3 %
8. Assay
Ambroxol Hydrochloride BP (15 mg) 90 % to 110 % of the labeled amount
PREPARED BY CHECKED BY APPROVED BY
NAME SAHIL PANCHAL SMIT PATEL ANIL PARMAR
DESIGNATION Q.C CHEMIST Q.C SR CHEMIST Q.C INCHARGE
SIGNATURE
DATE 01/01/2022 01/01/2022 01/01/2022
WEST-COAST Q.C. DEPARTMENT
FINISHED PRODUCT METHOD OF ANALYSIS
PRODUCTNAME: AMBROXOL MOA. No. : Supersedes : NIL
HYDROCHLORIDE SYRUP 15 MG/5 ML WC/QC/MOA/0550
Strength: 15MG/ 5 ML Effective Date :
01/01/2022 Page No. : 1 of 4
Specification : SPECIFICATION Revised Date : -----
DESCRIPTION
Clear colorless liquid
pH
The pH value of a syrup is determined potentiometrically by means of a glass electrode, a reference
electrode and pH meter. The determination each carried out at a temperature of a 25°C ± 2°C operate the
pH meter according to the manufactures instrument. Calibrate the apparatus using pH 6.0 TO 8.0 buffer
solutionas the primary std immerse the electrodes in syrup and measure the pH
WEIGHT PER ML:
Select a thoroughly clean & dry pycnometer. Calibrate the pycnometer by filling it with recently boiled
and cooled water at 25° & weighing the contents assuming that the weight of 1 ml of water at 25° when
weighed in air of density 0.0012 gm per ml, is 0.99602 gm. Calculate the capacity of the pycnometer.
(Ordinary deviations in the density of air from the value given do not affect the result of a determination
significantly) Adjust the temperature of the substance to be examined, to about 20° and fill the pycnometer
with it. Adjust the temperature of the filled pycnometer to 25°, remove any excess of the substance and
weigh. Substract the tare weight of the pycnometer the filled weight of the pycnometer. Determine the
weight per milliliter dividing the weight in air, expressing of the quantity of liquid which fills the
pycnometer at the specified temperature by capacity expressed in ml, of the pycnometer at the same
temperature.
DELIVERABLE VOLUME:
Check the volume of 10 bottles using the calibrated measuring cylinder the variation in volume of
individual bottle should be not less than Label claim of sample
IDENTIFICATION
The principal spot in the chromatogram obtained with the test solution is similar in position and size to the
principal spot in the chromatogram obtained with the reference solution.
MICROBIAL LIMIT TEST
1. Start LAF at least 10 min before MLT testing. Nose mask & sterile apron should be used before
entering in MLT room.
2. Check U.V lamp, before cleaning of LAF bench. U.V. lamp should be "OFF" during cleaning & testing.
PREPARED BY CHECKED BY APPROVED BY
NAME SAHIL PANCHAL SMIT PATEL ANIL PARMAR
DESIGNATION Q.C CHEMIST Q.C SR CHEMIST Q.C INCHARGE
SIGNATURE
DATE 01/01/2022 01/01/2022 01/01/2022
WEST-COAST Q.C. DEPARTMENT
FINISHED PRODUCT METHOD OF ANALYSIS
PRODUCTNAME: AMBROXOL MOA. No. : Supersedes : NIL
HYDROCHLORIDE SYRUP 15 MG/5 ML WC/QC/MOA/0550
Strength: 15MG/ 5 ML Effective Date :
01/01/2022 Page No. : 2 of 4
Specification : SPECIFICATION Revised Date : -----
3. Hands should be disinfected with the help of 70% IPA solution. After IPA spraying rub your hands for
proper disinfection. After that wait some times for drying your hands.
4. After drying cover your hands with the help of sterile surgical gloves and disinfect your hands with
70% IPA and rub again for proper disinfection.
5. After disinfection wait for some times for drying purpose. Take sterile glass plate and mark with the
help of marker. Name of media, Date of analysis & Sampling location should be mentioned on the plate or
test tube.
For Total Aerobic Microbial Count
Take 1 ml sample and inoculate in 50 ml Soyabean Casein Digest Broth (SCDB) (1:50) and shake it
properly for proper mixing. After mixing, pipette 5 ml sample from SCDB and inoculate in 10 ml Normal
Sterile Saline (NSS) test tube(1:100) and mix properly. After mixing, SCDB and NSS tube keep in the test
tube stand for 1 hr. Take 1 ml sample from SCDB and inoculate in plate No.1 and take other 1ml sample
from NSS and inoculate in plate No.2. After inoculation pour approximately 15 ml to 18 ml Soyabean
Casein Digest Agar in plate1 and plate 2. Temp of SCDA should be less than 45°c. After Soyabean Casein
Agar get solidified incubate both plates at 37°c for 72 hrs in inverted position.
For Yeast & Mold
Take1 ml of sample and inoculate in 10ml Nutrient broth (NB) (1:10) and incubate the tube at 37°c for 24
hrs. After 24 hrs take 5 ml sample from Nutrient broth and inoculate in 10 ml Normal Sterile Saline
(NSS) (1:20). Take 1 ml from NB and inoculate in plate no1. Other 1 ml from NSS and inoculate in plate
no2. After inoculation pour approximately 15 ml to 18 ml Sabouraud Dextrose Agar (SDA). Temperature
of SDA should be less than 45°c. After SDA gets solidify incubate both plates at 20°c-25°c for 5 days at
inverted position.
Tests for specified micro-organisms
For Escherichia Coli
Take 1 ml sample and inoculate in 50 ml Nutrient broth(NB). After inoculating incubate the broth at 37°c
for 24 hrs. After 24 hrs pipette out 1ml sample from NB and inoculate in MacConkey's broth and incubate
tubes at 37°c for 48 hrs. Production of acid and gas indicates the presence of E.coli.
Confirmatory Test
Take 2.5 ml of MacConkey’s broth and 2.5 ml peptone water, add 0.5ml of kovac’s reagent. Shake well
and allow to stand for 1 min. If reddish pink colour ring is found at the junction means the presence of
E.coli.
PREPARED BY CHECKED BY APPROVED BY
NAME SAHIL PANCHAL SMIT PATEL ANIL PARMAR
DESIGNATION Q.C CHEMIST Q.C SR CHEMIST Q.C INCHARGE
SIGNATURE
DATE 01/01/2022 01/01/2022 01/01/2022
WEST-COAST Q.C. DEPARTMENT
FINISHED PRODUCT METHOD OF ANALYSIS
PRODUCTNAME: AMBROXOL MOA. No. : Supersedes : NIL
HYDROCHLORIDE SYRUP 15 MG/5 ML WC/QC/MOA/0550
Strength: 15MG/ 5 ML Effective Date :
01/01/2022 Page No. : 3 of 4
Specification : SPECIFICATION Revised Date : -----
For Salmonella
Take 1 ml of sample and inoculate in 50 ml Nutrient Broth. Incubate the broth at 37°c for 24 hrs. After
incubation period take 1 ml from Nutrient Broth and inoculate in 10 ml of Tetrathionate Broth. Incubate
the broth at 37°c for 48 hrs. After incubation take a loopful from Tetrathionate broth and streak on
Brilliant Green Agar plate. Incubate the plate at 37°c for 24 hrs. Presence of small, transparent and
colorless, pinkish or white colony surrounded by pink or red zone indicates the presence of Salmonella.
Confirmatory Test
Take a suspected colony and streak on the slope of Triple Sugar Iron slant and stab the colony on the TSI
slant, incubate the slant at 37°c for 18 to 24 hrs. The formation of acid and gas in the stab with or without
blackening and the absence of acidity from the surface growth indicate the presence of Salmonella.
For Pseudomonas Aeruginosa
Take 1 ml of sample and inoculate in 50 ml Soyabean Casein Digest Broth (SCDB) & incubate at 37°cfor
24 to 48 hrs. After incubation take a loopful from SCD Broth and streak on Cetrimide agar Plate. After
incubation period the presence of greenish colony indicates the presence of Ps. Aeruginosa.
Confirmatory Test
Take a suspected colony and place 2 to 3 drops of freshly prepared N,N,N’,N’-tetra-methyl-4-
phenylenediamine dihydrochloride on filter paper and smear with the colony. The development of Pink
colour changing to purple indicates the presence of Ps.aeruginosa.
For Staphylococcus Aureus
Take 1 ml of sample and inoculate in 50 ml of Soyabean Casein Digest Broth. Incubate the broth at 37°c
for 18 to 24 hrs. After incubation take a loopful and streak on Vogel-Johnson Agar plate. Incubate the
plate at 37°c for 24 to 48 hrs. The presence of black coloured colony surrounded by yellow zone indicates
the presence of S.aureus.
Confirmatory Test
If growth occurs, carry out coagulase test. Take a suspected colony to individual tubes containing 0.5 ml
of mammalian plasma with or without additives. Incubate the tubes at 37°c for 3 hrs, subsequently at
suitable intervals up to 24 hrs. If coagulation in any degree is observed then the sample meets the presence
of S.aureus.
PREPARED BY CHECKED BY APPROVED BY
NAME SAHIL PANCHAL SMIT PATEL ANIL PARMAR
DESIGNATION Q.C CHEMIST Q.C SR CHEMIST Q.C INCHARGE
SIGNATURE
DATE 01/01/2022 01/01/2022 01/01/2022
WEST-COAST Q.C. DEPARTMENT
FINISHED PRODUCT METHOD OF ANALYSIS
PRODUCTNAME: AMBROXOL MOA. No. : Supersedes : NIL
HYDROCHLORIDE SYRUP 15 MG/5 ML WC/QC/MOA/0550
Strength: 15MG/ 5 ML Effective Date :
01/01/2022 Page No. : 4 of 4
Specification : SPECIFICATION Revised Date : -----
IMPURITIES
Unspecified impurities Not more than 0.10 %, Total impurities Not more than 0.3 %.
ASSAY
Each 5 ml contains:
Ambroxol Hydrochloride 15 mg
Column C18 (250 cm x 4.6 mm ),5 micron
Mobile phase 800 mg of potassium dihydrogen orthophosphate in
dilute to 500 ml volumetric Flask and dissolve
and filter with 0.2 micron filter paper and add 500
ml of acetonitrile and mix and sonicate for 15
minutes and filter the mobile phase
Flow rate 1.0 ml/minute
Detector Wavelength 248 nm
Injection volume 20 microlite
Standard solution: Weigh accurately 30 mg of Ambroxol Hcl working std in 50 ml volumetric flask and
add 20 ml of mobile phase and sonicate for completely dissolve it and make volume 50 ml with mobile
phase and further dilute 20 ml to 50 ml with mobile phase
Test preparation: take accurately 5 ml syrup in 50 ml volumetric flask and make volume with mobile
phase and then make further dilution 20 ml to 50 ml to mobile phase.
Procedure: Separately inject equal volumes (about 20μl) of the Standard solution and the Test solution
into the chromatograph, record the chromatograms, and measure the peak responses.
Calculation formula of Ambroxolol Hcl:
Test Area Std.Wt 20 50 50 Potency 100 5
= X X X X X X X
Std.Area 50 50 5 20 100 Label 1
PREPARED BY CHECKED BY APPROVED BY
NAME SAHIL PANCHAL SMIT PATEL ANIL PARMAR
DESIGNATION Q.C CHEMIST Q.C SR CHEMIST Q.C INCHARGE
SIGNATURE
DATE 01/01/2022 01/01/2022 01/01/2022
