we’ve got

you covered
pharmaceutical product
and solution guide
2/
we’ve got you covered
Helping to ensure the efficacy, integrity and usability of
pharmaceutical formulations
At Ashland, our number one goal is to help you apply pharmaceutical polymers in ways
that ensure the efficacy, integrity and usability of your formulations. Explore how our
molecular scientists, chemists, formulation development scientists and process engineers
can help advance formulation development, support the commercialization of complex
drug molecules, and reduce time to market. Our problem-solving team leverages a
diverse polymer portfolio to enable comprehensive solutions, so when you’re ready to
develop a formulation, we’ve got you covered.
Included here is an overview of Ashland’s pharmaceutical polymer offering along with
details about the properties of these technologies that form the basis of their extraordinary
functionality in finished dosage forms.

Application

Direct-compression
Tablet Film Coating

Drug Solubilization

Suspending Agent

Hot-melt Extrusion
Modified-release

Liquid Rheology

Crystallization
Tablet Binding

Disintegration
Matrix Former

Lyophilization

Modification
Tableting

Stabilizer

Stabilizer

Inhibitor
Product

Cellulosics – pages 3-6

Klucel™
    
hydroxypropylcellulose
Benecel™ methylcellulose
     
and hypromellose
Natrosol™ 250
 
hydroxyethylcellulose
AquaSolve™ hypromellose
  
acetate succinate

Aqualon™ ethylcellulose    

Aqualon and Blanose™

    
sodium carboxymethylcellulose

Cyclodextrins – page 7

CAVAMAX*, Cavitron™
  
and CAVASOL* cyclodextrins

Vinyl pyrrolidones – page 8

Plasdone™ S-630 copovidone     

Plasdone povidone
    
C grades
Plasdone™ povidone
   
K grades

Polyplasdone™ crospovidone  

Pharmasolve™

N-methyl-2-pyrrolidone

Film coating systems – pages 9-10

Aquarius™ film coating

 
systems

/3
 Klucel™ hydroxypropylcellulose AquaSolve™ hypromellose acetate
Klucel hydroxypropylcellulose (HPC) provides a succinate
remarkable set of physical properties for tablet AquaSolve hypromellose acetate succinate
binding, modified release, and film coating. It is (HPMCAS) is a cellulosic polymer with four
a surface active, thermoplastic polymer that is substituents randomly substituted on the available
soluble in both aqueous and organic solvents. hydroxyl groups with the following mass contents;
Low-viscosity E, L, and ELF types are widely used methoxyl, 12–18 wt%; hydroxypropoxy, 4–23 wt%;
for premier tablet binding at low-use levels (2–6%). acetyl, 2–16 wt% and succinoyl 4–28 wt%. It is
Regular particle size materials are used in wet white to yellowish white in color and has a faint
processing, and the X-grind material is used for acetic acid-like odor and a barely detectable
dry processing. taste.
The characteristics of Klucel HPC make AquaSolve HPMCAS is available in several grades
the low viscosity grades extremely useful varying in extent of substitution of acetyl and
in pharmaceutical film coatings, either for succinoyl groups, and in two particle sizes (fine or
application from aqueous (often preferred today) granular).
or organic solvent-based coating formulations.
The inherent compatibility with other commonly AquaSolve HPMCAS is used as a polymeric carrier
used polymers (such as HPMC) makes Klucel in solid dispersions for solubility enhancement of
HPC a useful formulation modifier to enhance poorly soluble active pharmaceutical ingredients
properties of the final coating formulation. Klucel (APIs). The amphiphilic nature, high glass-transition
HPC can also be a useful suspension stabilizer for temperature (Tg) and low viscosity in various
pigment dispersions that are used in color coating solvents of this polymer, are some of the unique
formulations. properties that make it ideal for use in spray-
dried dispersion formulations. Varying the level
Several high molecular weight grades are used of acetyl and succinoyl substitutions produces
for modified-release matrix systems. These grades polymers that can bond with either hydrophilic or
of HPC work by swelling and diffusion to retard hydrophobic APIs to help them solubilize.
drug release.
In oral pharmaceutical formulations, AquaSolve
Low molecular weight Klucel HPC polymers, due HPMCAS is commonly used as an enteric film
to their thermoplastic behavior and superior flow coating for tablets, capsules, or granules. For
properties, find applications in melt extrusion. aqueous film-coating purposes, a dispersion of
AquaSolve HPMCAS fine powder and a plasticizer
Klucel™ hydroxypropylcellulose (HPC) (such as triethyl citrate) in water is commonly
Weight Typical used. Organic solvents are also vehicles
Solution
Grade Average Brookfield
Concentration
for applying this polymer as a film coating.
(X = Fine) Molecular Viscosity AquaSolve HPMCAS can form films without the
(%)
Weight (mPa•s)
addition of water or solvents.
HF Pharm,
1,150,000 1,500–3,000 1
HXF Pharm Other pharmaceutical applications include its
MF Pharm,
850,000 4,000–6,500 2 use alone or in combination with other soluble or
MXF Pharm
insoluble binders in the preparation of granules
GF Pharm, with sustained-release properties, where the
370,000 150–400 2
GXF Pharm
release rate is pH dependent.
JF Pharm,
140,000 150–400 5
JXF Pharm
AquaSolve™ hypromellose acetate succinate
LF Pharm,
95,000 75–150 5 (HPMCAS)
LXF Pharm
EF Pharm, Weight Average Nominal Viscosity
80,000 300–600 10 Gradea
EXF Pharm Molecular Weight (mPa•s)b
ELF Pharm 40,000 150–225 10 L 114,700 2.4–3.6
M 103,200 2.4–3.6
H 75,100 2.4–3.6
Available in fine and coarse particle sizes
a

NF/EP/JP viscosity method

b

/4
Benecel™ methylcellulose and hypromellose
Benecel methylcellulose (MC) and hypromellose (hydroxypropylmethylcellulose or HPMC) are versatile
excipients with a variety of applications. Ashland offers various substitution low molecular weight types
and grades of HPMC hypromellose. High-viscosity grades of HPMC are widely used in hydrophilic to
retard the release of active pharmaceutical ingredients from matrix tablets.

Custom Intermediate-molecular Weight Grades for Controlled-release

Achieving a desired drug-release profile has traditionally involved blends of different molecular weights
of particular polymers. Blending, however, can increase release-profile variability. Benecel K250 PH
PRM, K750 PH PRM and K1500 PH PRM HPMC were developed to obviate the need for blending and
offer a potential solution to the problem of dissolution variability.

Directly Compressible Grades

Directly compressible (DC) grades enable the production of controlled-release formulations with the
convenience of the most widely used tablet-binding mechanism. These Benecel DC HPMC grades
offer good powder flow, content uniformity, and compressibility, making them well suited for direct
compression.

Benecel™ hypromellose (HPMC)

Weight Average Solution Nominal Viscosity
Substitution Type Grade
Molecular Weight Concentration (mPa•s)a
E4M Pharm,
400,000 2% 2,700–5,040
Hypromellose 2910 E4M Pharm CR
“E” types E10M Pharm,
746,000 2% 7,500–14,000
E10M Pharm CR
K100 LV PH PRM 164,000 2% 80–120
K250 PH PRM 200,000 2% 200–300
K750 PH PRM 250,000 2% 562–1050
K1500 PH PRM 300,000 2% 1,125–2,100
K4M Pharm,
400,000 2% 2,700–5,040
K4M Pharm CR
Hypromellose 2208
“K” types K15M Pharm,
K15M Pharm CR, 575,000 2% 13,500–25,200
K15M PH PRM
K35M Pharm 675,000 2% 26,250–49,000
K100M Pharm XR 1,000,000 2% 75,000–140,000
K200M Pharm,
1,200,000 2% 150,000–280,000
K200M Pharm CR
a
NF/EP/JP viscosity method

Benecel™ directly compressible hypromellose (HPMC)

Weight Average Solution Nominal Viscosity
Substitution Type Grade
Molecular Weight Concentration (mPa•s)a
K4M PH DC1 400,000 2% 2,700–5,040
Hypromellose 2208 “K”
K15M PH DC1 575,000 2% 13,500–25,200
types
K100M PH DC1 1,000,000 2% 75,000–140,000
a
NF/EP/JP viscosity method 1
These grades are co-processed with silica at <1 %

Benecel™ methylcellulose (MC) and methylhydroxyethylcellulose (MHEC)

Substitution Type Grade Nominal Viscosity (mPa•s)a
A15 LV PH PRM 12–18
A4C Pharm 300–560
Methylcellulose
A15C Pharm 1,312–2,450
A4M Pharm 2,700–5,040
Methylhydroxyethylcellulose ME 233 P Pharm 3,100–5,700
a
NF/EP/JP viscosity method
CR grades available
1

5/
 Aqualon or Blanose™ sodium carboxymethylcellulose
Aqualon or Blanose sodium carboxymethylcellulose (CMC) is made by reacting sodium
monochloroacetate with alkali cellulose under rigidly controlled conditions. The resultant anionic
polymer is purified and dried. A variety of CMC grades is available, with varying degrees of
substitution, viscosities, and particle sizes. Typical uses for CMC are in ointments, creams, and lotions,
as a stabilizer, thickener and film-former; in jellies and salves, as a thickener, gelling agent, protective
colloid and film-former; in syrups and suspensions, as a thickener and suspending aid; in bulk laxatives,
as a physiologically inert water-binding agent; in mucoadhesives for its absorbency and sustained-
released properties. High-viscosity grades of CMC can also be used in hydrophilic matrix tablets.
Bioburden and endotoxin tested (BET) grades are available.
Ashland provides sodium carboxymethylcellulose to the pharmaceutical market under the trade
names Aqualon or Blanose, depending on the region. These products are produced to USP-NF 1078
and IPEC-PQC GMP guidelines for excipients.

Aqualon™ sodium carboxymethylcellulose (CMC)

Weight Average Viscosity Solution Degree of Substitution

Molecular Weight (mPa•s) Concentration 0.7 0.9 1.2
725,000 1,500–3,000 1% 7HF PH
725,000 1,000–2,800 1% 7H3SF PH
725,000 1,000–2,800 1% 7HOF PH
395,000 1,500–3,100 2% 9M31F PH
395,000 800–3,100 2% 12M31P
250,000 400–800 2% 7MF PH
250,000 400–800 2% CMC 7MF PH BET
250,000 400–800 2% 7M8SF PH
250,000 400–800 2% 9M8F PH
90,500 25–50 2% 7LF PH
90,500 25–50 2% CMC 7LF PH BET
49,000 50–200 4% 7L2P
49,000 50–200 4% CMC 7L2P BET

Blanose™ sodium carboxymethylcellulose (CMC)

Weight Average Viscosity Solution Degree of Substitution

Molecular Weight (mPa•s) Concentration 0.7 0.9 1.2
725,000 2,500–4,500 1% 7H4XF PH 9H4XF PH
725,000 1,500–2,500 1% 7HF PH
725,000 1,000–2,800 1% 7H3SF PH
725,000 1,000–2,800 1% 7HOF PH
395,000 1,500–3,100 2% 7M31F PH 9M31F PH 12M31P
395,000 200–800 2% 7M8SF PH
395,000 1,200–1,800 2% 9M20F PH
395,000 400-800 2% 12M8P
250,000 400–600 2% 7MF PH
250,000 50–100 2% 7M1F PH
90,500 25–50 2% 7LP EP

6/
Aqualon™ ethylcellulose CAVAMAX*, CAVASOL* and Cavitron™
Aqualon ethylcellulose is soluble in a wide range cyclodextrins
of organic solvents. Typically, ethylcellulose is used The molecular structure of cyclodextrins creates
as a nonswellable, insoluble component in matrix a bucket-like cavity that can complex with
or coating systems. Ethylcellulose can be used to molecules or functional groups on molecules to
coat one or more active ingredients of a tablet to improve solubility of poorly soluble compounds.
prevent them from reacting with other materials The same mechanism makes these excipients
or with one another. It can prevent discoloration capable of masking unpleasant taste/odor and
of easily oxidized substances, such as ascorbic stabilizing APIs that are prone to degradation.
acid. Ethylcellulose can be used on its own or in
combination with water-soluble components to
prepare sustained-release film coatings that are CAVAMAX* native cyclodextrins
frequently used for the coating of microparticles, The number of glucose units in the ring
pellets, and tablets. Aqualon T10 Pharm determines the internal diameter of the cavity
ethylcellulose was developed for optimized and its volume, as the height of the cyclodextrin
compactability (with high ethoxyl content and cavity is the same for all the native cyclodextrin
low viscosity) and good powder flow. grades. CAVAMAX cyclodextrins are compatible
with a wide range of ingredients commonly used
Aqualon™ ethylcellulose (EC) in pharmaceutical applications.
Weight Typical
Grade
Ethoxyl
Substitution
Average Brookfield
Solution
Concentration
CAVASOL* and Cavitron
(%)
Molecular
Weight
Viscosity
(mPa•s)1
(%) hydroxypropyl-ß- or hydroxypropyl-γ-
T10 Pharm 49.6–51.0 75,000 8–11 5
cyclodextrins (HPBCD or HBGCD)
N7 Pharm 48.0–49.5 65,000 6–8 5 The substitution of hydroxyl groups on native
N10 Pharm 48.0–49.5 75,000 8–11 5 cyclodextrins to make hydroxypropyl-ß- or
N14 Pharm 48.0–49.5 120,000 12–16 5 hydroxypropyl-γ-cyclodextrins (HPBCD or
N22 Pharm 48.0–49.5 140,000 18–24 5
HBGCD) significantly enhances their solubility.
Both CAVASOL HPBCD and HPGCD are primarily
N50 Pharm 48.0–49.5 160,000 40–52 5
used to increase solubility of poorly soluble
N100 Pharm 48.0–49.5 215,000 80–105 5
compounds in oral drug-delivery systems.
Viscosity measured in 80:20 mixture of toluene/ethanol
1
Cavitron cyclodextrins are manufactured and
Natrosol™ 250 hydroxyethylcellulose tested to meet low bioburden and endotoxin
specifications.
Natrosol 250 hydroxyethylcellulose (HEC) is a
nonionic water-soluble cellulose ether. Natrosol Cyclodextrin derivatives
250 HEC is easily dispersed in cold or hot water
to give solutions of varying viscosities and desired Product and Weight Average Typical Degree of
Grade Molecular Weight Substitution
properties, though it is insoluble in organic
CAVASOL* W7 HP
solvents. It is used in solutions and gels to control 1,410 4.1–5.1
Pharma
rheology, in emulsions for high-salt tolerance
Cavitron™ W7 HP5
and surfactant compatibility and in modified- Pharma
1,410 4.1–5.1
release matrix tablets, where high-viscosity grades Cavitron W7 HP7
1,520 6.0–8.0
provide effective diffusion-limiting release of Pharma
active pharmaceutical ingredients (API) with low CAVASOL* W8 HP
1,574 3.5-4.9
water solubility. Pharma
*
Registered trademark owned by Wacker Chemie AG. Ashland acts as a worldwide
distributor for Wacker.
Natrosol™ 250 hydroxyethylcellulose (HEC)
Weight Typical Native cyclodextrins
Grade Average Brookfield Solution
(X = Fine,
Molecular Viscosity Concentration Product and Weight Average
W = Superfine) Cyclodextrin Type
Weight (mPa•s) Grade Molecular Weight
HHX Pharm, CAVAMAX* W6
1,300,000 3,500–5,500 1% 973 α-cyclodextrin
HHW Pharm Pharma
HX Pharm, CAVAMAX* W7
1,000,000 1,500–2,500 1% 1,135 β-cyclodextrin
H Pharm Pharma
M Pharm 720,000 4,500–6,500 2% CAVAMAX* W8
1,297 γ-cyclodextrin
Pharma
G Pharm 300,000 250–400 2%
*
Registered trademark owned by Wacker Chemie AG. Ashland acts as a worldwide
L Pharm 90,000 75–150 5% distributor for Wacker.

7/
 Plasdone S-630 copovidone Polyplasdone™ crospovidone
Plasdone S-630 copovidone (PVP/VA) is a tablet Polyplasdone crospovidone superdisintegrants
binder, matrix polymer for solid-dispersion are synthetic, insoluble but rapidly swellable,
formulations and film-former for topical crosslinked homopolymers of N-vinyl-2-
applications. It is commonly used to enhance pyrrolidone. Crospovidone provides rapid
the solubility of APIs and increase bioavailability disintegration and dissolution to oral solid-dosage
of poorly water-soluble APIs through the forms. Polyplasdone crospovidone particles
formation of melt-extruded or spray-dried solid are granular and porous compared with other
dispersions. It is a linear, random, water-soluble superdisintegrants. The high surface area
copolymer of N-vinylpyrrolidone and vinyl combined with unique chemistry results in high
acetate that combines a unique set of properties interfacial activity that enhances the dissolution
for application in a wide variety of dosage of poorly water-soluble active pharmaceutical
forms. Reduced hygroscopicity makes it useful in ingredients (APIs) in a way that is not possible with
moisture-sensitive formulations. other disintegrant technologies.

Plasdone™ copovidone Polyplasdone™ crospovidone

Weight Average Peroxide
Grade K-Value Viscosity Typical Average Particle
Molecular Weighta Grade Specification
Size (Microns)
S-630 47,000 25.0–31.0 (ppm)
Ultra1 110–140 30 Max
a
Absolute molecular weight (SEC/MALLS)
XL1 110–140 400 Max

Plasdone™ povidone Ultra-102 25–40 50 Max

XL-102 25–40 400 Max
Ashland offers a comprehensive range of
Ph. Eur. crospovidone monograph type A
Plasdone povidone (PVP). Plasdone povidones
1

2 Ph. Eur. crospovidone monograph type B

are a family of water-soluble polymers based on
N-vinylpyrrolidone that combine a unique set Pharmasolve™ N-methyl-2-pyrrolidone
of properties for application in a wide variety
Pharmasolve N-methyl-2-pyrrolidone (NMP) is a
of dosage forms. Plasdone povidones are
water-miscible polar aprotic solvent with high
commonly used as binders for the development
interfacial activity. It is used as a solubilizer and
of tablet formulations, whether manufactured
penetration enhancer in human parenteral and
by wet granulation, dry granulation, or direct
topical-dosage forms, as well as parenteral and
compression. Plasdone K polymers are used in
topical veterinary products.
solid-dispersion formulations to enhance the
solubility of active pharmaceutical ingredients
and increase bioavailability. Plasdone K grades
are also used to inhibit recrystallization in liquid
soft gels. Plasdone C polymers can inhibit
crystallization in injectable dosage forms are
produced to meet low pyrogen specifications.

Plasdone™ povidone
Weight Average
Gradea K-Value Viscosity
Molecular Weightb
K-12 4,000 10.2–13.8
K-17 10,000 16.0–17.5
K-25 34,000 24–26
K-29/32 58,000 29–32
K-90 1,300,000 85–95
C-12 4,000 10.2–13.8
C-17 10,000 16.0–17.5
C-30 58,000 29.0–32.0
a
C grades have low pyrogen levels
b
Absolute molecular weight (SEC/MALLS)

/8
Aquarius™ film coating systems
Fully formulated, easily dispersed and ready-to-use, Aquarius film coating systems provide a range of
functions to suit almost any core. A wide range of film coating offerings enable us to supply an optimal
coating for your formulation.

Aquarius Preferred film coating -- Capability to address common film coating

systems problems

High-solids loadings, such as the Aquarius -- Disperse easily in water

Preferred series serve to maximize the efficiency
-- Immediate release
of the coating application process. By reducing
coating time, productivity is increased, while Aquarius Prime LS film coating
overall manufacturing cost is reduced. High-solids
cellulosic or high-solids copovidone formulations
systems
improve film adhesion to all substrates, especially Ashland’s LS series of Aquarius Prime film coatings
those that present challenges in aqueous film are made from hypromellose (HPMC) and
coating. The benefits of Aquarius Preferred lactose and are intended to be qualitatively,
systems include: quantitatively, and functionally equivalent to
competitive lactose-based film coating systems.
-- High-solids coatings The benefits of LS film coatings include:
-- Immediate-release -- A significant improvement in film adhesion
-- Disperse easily in water capabilities compared with standard HPMC-
based film coating systems
-- Applicable to both pharmaceutical and
nutraceutical solid dosage forms -- Spray at up to 20% w/w solids but, more
realistically, at 17–18% w/w solids
-- Can be tailored to meet exacting requirements
Aquarius Protect film coating system
Aquarius Prime film coating systems
Aquarius Protect is the premium multi-functional
Film coatings for immediate-release tablet- barrier coating system that effectively reduces
coating applications are typically comprised of
moisture uptake and masks against offensive
a polymer, a plasticizer, and optional pigment/
taste and odor.
opacifier. Aquarius Prime film coating systems
are available off the shelf in clear and white -- More natural, protective film coating
formulations. The benefits of these coating
systems include: -- Protection from moisture, odors or offensive
tastes in oral solid dosage forms
-- Cellulosic polymer composition (typically HPMC -- A water-based coating system
and HPC, and combinations thereof)
-- A range of choices - clear, white, and
-- Designs that meet general film coating pigmented variations (Clears: 10–12% solids;
requirements (typically sprayable at 10–15% White and colors can be sprayed up to 20%
w/w solids, producing coatings with good solids, remain non-tacky, and enable significant
film strength and moderate film adhesion process savings)
characteristics)

Aquarius™ film coating systems

Grade Descriptor Detail Class
Preferred HSC High-solids coatings based on cellulosic polymers
Aesthetic

High-solids coatings based on copovidone with cellulosic polymers for significant improvements in
Preferred HSP
adhesion and sprayable solids
Prime - Coatings based on traditional cellulosic polymers
Prime LS Coatings based on lactose
Protect - Label-friendly moisture, odor and taste guard
Functional

Control ENA Delayed-release (enteric) coatings based on methacrylic acid-ethyl acrylate copolymer

Control SRX Sustained-release coatings based on ethylcellulose

/9
 Aquarius Control ENA film coating systems
The ENA series of Aquarius Control film coatings are
designated for use in delayed-release (enteric) coatings.
The benefits of these systems include:
-- Protection of active pharmaceutical ingredients (APIs)
that degrade in gastric fluid
-- Prevention of the API release that may irritate the gastric
mucosa
-- Provision of stable dissolution profiles over a wide pH
range
-- Production of stable release profiles over periods of up to
12 months

Aquarius Control SRX film coating systems

The SRX series of Aquarius Control film coatings are
designated for use in sustained-release coatings wherein
APIs are most effective when released over time. The
benefits of these systems include:
-- Solvent-dispersible ethylcellulose coatings for
multiparticulates, potentially modified with
hydroxypropylcellulose as a pore former
-- Variable porosities can be matched to active
pharmaceutical ingredient solubility and/or desired
release profile
-- Produces coatings that do not require curing after
application
These film coating systems produce predictable and
controllable release profiles, are custom formulated
based on solubility and desired release profile, and do not
require a coalescence step.
For more information about Aquarius film coating systems,
please visit our film coating troubleshooting guide online
at filmcoating-troubleshooting.com.

10 /
Technical Capabilities
We offer a range of technical capabilities to meet the needs of the pharmaceutical and nutraceutical
industries. Through a global network of technical service laboratories, we provide assistance with
formulation development, problem-solving and analytical support. Our facilities are located in
Wilmington, Del., USA; São Paulo, Brazil; Mexico City, Mexico; Buenos Aires, Argentina; Düsseldorf,
Germany; Hyderabad, India; Istanbul, Turkey; and Shanghai, China;
Our scientists support the pharmaceutical industry with formulation and process development in solid
dispersion technology (hot-melt extrusion and spray drying), granulation technologies (fluid bed,
high shear, hot-melt extrusion) and controlled-release technologies (release-profile prediction and
simulation, melt extrusion, particle and pellet coating, drug layering, matrix tablets).
Additional capabilities include compaction simulation, tablet production and film coating, and
stability studies. Ashland also has considerable expertise in characterization of powder properties (flow,
particle size, surface area, and morphology).

Analytical and testing capabilities include: Pilot manufacturing capabilities include:

-- Advanced powder flow and segregation testing -- Fluid beds with capacity up to 5 kg
-- Dissolution USP I, II and III -- Several sizes of tablet coaters
-- Differential scanning calorimetry and -- Numerous tablet presses and MEDELPHARM
thermogravimetric analysis StylOne Evolution and Stylcam compaction
simulators
-- Melt rheology
-- Extrusion/spheronization
-- Microscopy—scanning electron, polarized light,
and high resolution digital -- Hot-melt extruders
-- Kinetic dissolution -- Spray dryers
-- Advanced mechanical testing -- Formulation design
-- Size exclusion chromatography -- Oral solid dosage forms
-- Karl Fischer titration
-- Coulometry
-- Nuclear magnetic resonance
-- High-performance liquid chromatography and
gas chromatography
-- Infrared and ultraviolet spectroscopy
-- X-ray powder diffraction
-- Laser diffraction
-- ASTREE electronic tongue taste masking
analyzer

Regulatory Information

The regulatory compliance information for all Ashland products varies by product family and grade. Certain Ashland products
are harmonized monographs in the NF, Ph. Eur. and JP. Because the compendia allow for non-harmonized attributes by region, for
specific data about the grade you are interested in, please refer to our Excipient Information Package or the Certificate of Analysis.

Our staff is very involved in regulatory advocacy activities and trade associations. Among other areas of participation, Ashland was
a founding member of the International Pharmaceutical Excipients Council (IPEC) Americas and participates on many committees.
We are also active participants in IPEC Europe, IPEC China, IPEC India and SINDUSFARMA in Brazil. In addition, we are active in the
ASTM International D01.36 Cellulose subcommittee.

/ 11
GLOBAL HEADQUARTERS The information contained in this brochure and
the various products described are intended
Ashland Inc. for use only by persons having technical skill
and at their own discretion and risk after
50 East RiverCenter Blvd. they have performed necessary technical
Covington, KY 41012-0391 U.S.A. investigations, tests and evaluations of the
Tel: +1 859 815 3333 products and their uses. Certain end uses of
these products may be regulated pursuant to
rules or regulations governing medical devices,
REGIONAL CENTERS drug uses, or pesticidal or antimicrobial uses. It
is the end user’s responsibility to determine the
Europe — Switzerland applicability of such regulations to its products.
Tel: +41 52 560 55 00 All statements, information, and data presented
herein are believed to be accurate and reliable,
India — Maharashtra but are not to be taken as a guarantee of fitness
for a particular purpose, or representation,
Tel: +91 22 61489696 express or implied, for which seller assumes
legal responsibility. No freedom to use any
patent owned by Ashland, its subsidiaries, or its
Asia Pacific — Singapore suppliers is to be inferred.
Tel: +65 6775 5366

Middle East, Africa — Dubai, U.A.E.

Tel: +971 4 3818515

Middle East, Africa — Istanbul Turkey

Tel: +90 216 538 08 00

Latin America — Mexico

Tel: +52 55 52 76 6121

ashland.com/contact
®
Registered trademark, Ashland or its subsidiaries,
registered in various countries
™
Trademark, Ashland or its subsidiaries, registered in
various countries
©
2016, Ashland / PHA17-1001