Handbook of Pharmaceutical Additives, Third Edition (Ash, Handbook of Pharmaceutical Additives)

2995 Pages·2007·4.56 MB·English

Handbook of

Pharmaceutical
Additives
Third Edition
Handbook of
Pharmaceutical
Additives

Third Edition

Compiled by

Michael and Irene Ash

Synapse Information Resources
© Synapse Information Resources, Inc. 2007, 2008

All rights reserved. No part of this publication may be reproduced, stored in a retrieval system, or transmitted in any
form or by an means, electronic, mechanical, photocopying, recording, or otherwise without the prior permission of
Synapse Information Resources, Inc.

Published by
Synapse Information Resources, Inc.
1247 Taft Ave.
Endicott, NY 13760

Library of Congress Control Number: 2007922141

ISBN-13: 978-1-890595-93-7
ISBN-10: 1-890595-93-4

Printed in the U.S.A.
Contents

Preface ......................................................................................................................................................v
Abbreviations .....................................................................................................................................vii
Part I Trade Name Reference..............................................................................................15
Part II Chemical Component Cross-Reference.................................................................808
Part III Functional/Application Index................................................................................2260
Part IV Manufacturers Directory........................................................................................2608
Appendix .................................................................................................................................2761
CAS Number Index.................................................................................................2762
EINECS/ELINCS Number Index.............................................................................2853
FEMA Number Index..............................................................................................2910
Inactive Ingredient Guide: Approved Products...................................................2928
Inactive Ingredient Guide: Permanently Listed Color Additives.......................2965
USP and/or NF Compliant Chemicals...................................................................2968
BP Compliant Chemicals.......................................................................................2971
EP Compliant Chemicals.......................................................................................2975
Glossary..................................................................................................................2978
Bibliography...........................................................................................................2993
Preface

The Handbook of Pharmaceutical Additives, Third Edition has been extensively updated from the previous edition
which was published five years ago. This edition contains completely new trade name and generic chemical entries
as well as added information for previously listed excipients. The new edition reflects the many changes in the
manufacturers of both trade name and generic products. More than 5300 trade name products and 4000 generic
chemicals and materials, available from worldwide manufacturers are described in this reference.

Pharmaceutical additives are defined here as the secondary ingredients that are present in both prescription and
over-the-counter drug formulations and contribute in one or more of the following ways:
• improving consumption ease of the dosage form by masking unpleasant odor, improving palatibility or
appearance of the active ingredient.
• enabling or enhancing the delivery of the drug or medicine that is available in a variety of dosage forms (i.e., oral;
topical, ophthalmic, and otic; suppositories; injectables; inhalants) and thus improving its efficacy, control of
bioavailability, uniformity, and/or flow characteristics
• increasing the stability of active ingredients.
• acting as a filler or diluent so that an adequate amount of material is available to properly fill a dosage form.
• acting as an antimicrobial or antioxidant to extend the shelf life of the active ingredient.

Thus, the definition of pharmaceutical additives for the purpose of this book encompasses excipients, synergists, or
chemicals that substantively contribute to the effectiveness of the active ingredient. Entries for both trade names and
chemicals contain extensive information gathered from worldwide manufacturers, distributors, trade journals,
government documents, and other reference sources.

The Handbook of Pharmaceutical Additives, Third Edition centralizes and integrates information on these
chemicals and materials thereby serving as an essential guide to pharmaceutical product managers, formulation
scientists, quality controllers, ingredient chemists, pharmacists, physicians, and consumers.

This reference contains the following sections:

Part I
Trade Name Reference contains over 5300 alphabetical entries of trade name pharmaceutical additive products with
extensive profiles of each product listed.

Part II
Chemical Component Cross-Reference contains almost 4000 pharmaceutical chemicals/materials that are either
contained in the trade name products profiled in Part I or are generic chemicals used as pharmaceutical additive
ingredients. Each entry includes, wherever possible, its synonyms, CAS number, EINECS number/ELINCS, FEMA
number, UN/DOT number, molecular and empirical formulas, chemical properties, functions and applications,
toxicology, precautions, use levels, regulatory information, and manufacturers and distributors of the chemical. All
chemical/material synonyms are cross-referenced back to the main entry. The chemical monograph entries also
contain a listing of the trade name products that are either equivalent to the chemical entry or contain this chemical as
one of its ingredients

Part III
Functional/Application Index is a powerful tool for locating the trade names and chemicals based on their function
and application. By searching for key functional words related to pharmaceutical additives such as anticaking agents,
binders, colorants, disintegrants, emulsifiers, encapsulants, fillers, flavors, gellants, in specific application areas such
as tablets, capsules, inhalants, ointments, suppositories, etc., the user is directed to the trade names and/or
chemicals that have that specific functional/application attribute.

Part IV
Manufacturers Directory contains detailed contact information for the more than 3000 worldwide manufacturers and
their branches of trade name products and chemical components that are referenced in this handbook. Wherever
possible, telephone, telefax, toll-free numbers, e-mail and internet addresses, and complete mailing addresses are
included for each manufacturer.

Appendixes
CAS Number Index contains CAS number entries followed by a listing of their trade name product and chemical
Handbook of Pharmaceutical Additives, Third Edition v
Preface
equivalents in alphabetical order. The chemical name is in boldfaced type.

EINECS/ELINCS Number Index contains EINECS/ELINCS number entries followed by a listing of their trade name
product and generic chemical equivalents in alphabetical order. The chemical name is in boldfaced type.

FEMA Number Index orders chemicals (that have assigned FEMA numbers) contained in this reference by these
numbers. These numbers have been assigned by the Flavor and Extract Manufacturers Association).

Glossary contains definitions of terminology associated with the pharmaceutical industry.

Chemicals in Compliance with Pharmaceutical Standards:
Inactive Ingredient Guide: Approved Products
Inactive Ingredient Guide: Permanently Listed Color Additives
USP/NF Chemical Listing
British Pharmacopoeia Chemical Listing
European Pharmacopoeia Chemical Listing

M. & I. Ash
Handbook of Pharmaceutical Additives, Third Edition vi
Abbreviations

abs. absolute BGA Federal Republic of Germany Health
ABS acrylonitrile-butadiene-styrene Dept. certification
absorp. absorption BgVV Bundesinsititut fŸr Gesundheitlichen
ACGIH American Conference of Verbraucherschutz und
Governmental Industrial Hygienists VeterinŠrmedizin (Federal Institute for
ACN acrylonitrile Consumer Health Protection and
act. active Veterinary Medicine) (Germany)
ADI acceptable daily intake (FAO/WHO) BHA butylated hydroxyanisole
ADR adverse drug reactions BHT butylated hydroxytoluene
AEL acceptable exposure limit biochem. biochemical
adsorp. adsorption biodeg. biodegradable
agric. agricultural bldg. building
agrochem. agrochemical blk. black
a.i. active ingredient BMC bulk molding compound
AIHA American Industrial Hygiene BOD biochemical oxygen demand
Association BP British Pharmacopeia
alc. alcohol b.p. boiling point
Am., Amer. American BR butadiene rubbers, polybutadienes
amts. amounts B&R Ball & Ring
anhyd. anhydrous br., brn. brown
ANSI American National Standards Institute brnsh. brownish
AOC assimilable organic carbon BS British Standards
APHA American Public Health Association B/S butadiene/styrene
API Active Pharmceutical Ingredients BSI British Standards Institute
applic(s). application(s) BSS British Standard Sieve
aq. aqueous Btu British thermal unit
AS acrylonitrile-butadiene-styrene B.U. Brabender units (viscosity)
ASA acrylic-styrene-acrylonitrile BVC British Veterinary Codex
ASBC Am. Society of Brewing Chemists BVO brominated vegetable oil
ASTM American Society for Testing and byprod. byproduct(s)
Materials C degrees Centigrade
ATH alumina trihydrate CAA Clean Air Act
atm atmosphere CAB cellulose acetate butyrate
at.wt. atomic weight calcd. calculated
autoignit. autoignition cap. capillary
aux(s). auxiliary, auxililaries CAS Chemical Abstracts Service
avail. available CC closed cup
avg. average cc cubic centimeter(s)
a.w. atomic weight CCFAC Codex Committee on Food Additives
BAC biological activated carbon and Contaminants
BATF Bureau of Alcohol, Tobacco, and CCl carbon tetrachloride
4
Firearms (U.S.) CD completely denatured
BDG butyl diglycol CDA completely denatured alcohol
BDOC biodegradable dissolved organic CEL corporate exposure limit
carbon CERCLA Comprehensive Environmental
BfArM Bundesinstitut fŸr Arzneimittel und Response, Compensation, & Liability
Medizinprodukte (Federal Institute for Act (U.S.)
Drugs and Medical Devices, CFC chlorofluorocarbon
Germany) CFN Council on Food & Nutrition (Am.
Medical Assoc.)
Handbook of Pharmaceutical Additives, Third Edition vii
Abbreviations
CFR Code of Federal Regulations (U.S.) DEA diethanolamide, diethanolamine
cfu colony-forming units dec. decomposes
cGMP current good manufacturing practice decomp. decomposition
(U.S. FDA) DEG diethylene glycol
ch. Chapter deliq. deliquescent
char. characteristic, characterized dens. density
chel. chelation deriv(s). derivative(s)
chem(s). chemical(s) descrip. description
CI Color Index dg decigram(s)
CIIR chlorobutyl rubber DI deionized
CIR Cosmetic Ingredient Review diam. diameter
cks centistoke(s) dielec. dielectric
cl clear dil. dilute
CL ceiling concentration DIN Deutsches Institut fuer Normung
cm centimeter(s) (German Standards Organization)
cm3 cubic centimeter(s) disp. dispersible, dispersion
CMC carboxymethylcellulose dissip. dissipation
CMC critical Micelle concentration dist. distilled
c.m.p. capillary melting point distort. distortion
CNS central nervous system distrib. distributor
CO carbon monoxide dk. dark
COC Cleveland Open Cup DMF dimethyl formamide
COD chemical oxygen demand DMF Drug Master Files
coeff. coefficient DO dissolved oxygen
COF coefficient of friction D.O. dissolved oxygen
compat. compatible DOC dissolved organic carbon
compd(s). compound(s) DOM dissolved organic matter
compr. compression DOP dioctyl phthalate
conc(s). concentrated, concentration(s) DOT Department of Transportation (U.S.)
conduct. Conductive, conductivity DPG diphenyl guanidine, dipropylene glycol
const. constant DSB dry solids basis
contg. containing DSI Canadian Provisional Domestic
cosolv. cosolvent Substance list
CP Canadian Pharmacopeia DTUL deflection temperature under load
cp centipoise(s) DVB divinylbenzene
CPE chlorinated polyethylene DW distilled water, deionized water
cps centipoise(s) DWV drainage, waste and vent
CPVC chlorinated polyvinyl chloride eb, EB electron beam
CR chloroprene rubber, polychloroprene EC European Community
cryst. crystalline, crystallization EC50 environmental concentration, 50%
cs centistoke(s) EDTA ethylenediamine tetraacetic acid
cSt centistoke(s) EE epoxy equivalent
CTFA Cosmetic, Toiletry and Fragrance EEC European Economic Community
Association EED environmental endocrine disrupter
ctks centistoke(s) EEW epoxide equivalent weight
CWA Clean Water Act e.g. for example
cwt hundred weight EGC Epoxide Group Content
DAB Deutsche. Arzneibuch (German EINECS European Inventory of Existing
Pharmacopoeia) Commercial Chemical Substances
DAC Deutscher Arneimittel Codex (German elec. electrical
Pharmacopoeia Codex) ELINCS European List of Notified Chemical
D&C Drugs & Cosmetics Substances
dc direct current elong. elongation
DE dextrose equivalent EMI electromagnetic interference
Handbook of Pharmaceutical Additives, Third Edition viii
Abbreviations
EMS electromagnetic shielding g gram(s)
ENB 5-ethylidene-2-norbornene gal gallon(s)
EO ethylene oxide g/d gram/dyne
EP European Pharmacopoeia GFRP glass fiber-reinforced plastic
EP extreme pressure G-H Gardner-Holdt
EPA Environmental Protection Agency GI gastro-intestinal
(U.S.) glac. glacial
EPDM ethylene-propylene-diene rubber, GLP good laboratory practice
ethylene-propylene terpolymer GLY glycine
EPR ethylene-propylene rubber GMP good manufacturing practice
EPS expandable polystyrene gpd gallons per day
equip. equipment gpm gallons per minute
equiv. equivalent GPPS general purpose polystyrene
ESCR environmental stress crack resistance gpt gallons per ton
ESD electrostatic discharge gr. gravity
ESO epoxidized soybean oil gran. granules, granular
ESP electrostatic protection GRAS generally regarded as safe
esp. especially grn(sh). green. greenish
EU European Union GRP glass-reinforced plastics, glass-
Eur.Ph. European Pharmacopeia reinforced polyester
EVA ethylene vinyl acetate GVS Gardner varnish scale (color)
evap. Evaporation GWP Global warming potential
exc. excellent h hour(s)
F degrees Fahrenheit HAF high abrasion furnace carbon black
FA fatty acid HALS hindered amine light stabilizer
FAO Food and Agriculture Organization HAP hazardous air pollutant
(United Nations) HAPS hazardous air pollutants
FAP Food Additive Petition (U.S.) HAP's hazardous air pollutants
FCC Food Chemicals Codex HB horizontal burning
FCC fluorochlorocarbon HC hydrocarbon
FDA Food and Drug Administration (U.S.) HCFC hydrochlorofluorocarbon
FD&C Foods, Drugs, and Cosmetics HCl hydrochloride, hydrochloric acid
FEMA Flavor and Extract Manufacturers’ HDPE high-density polyethylene
Association (U.S.) HDT heat distortion (deflection) temp.
FEP fluorinated ethylene propylene HFC hydrofluorocarbon
FFA free fatty acid Hg mercury
FFDCA Federal Food, Drug, and Cosmetic Act HIPS high-impact polystyrene
FG food grade HLB hydrophilic lipophilic balance
FIFRA Federal Insecticide, Fungicide, and HMIS Hazardous Material Identification
Rodenticide Act (U.S. EPA) System
FKM fluoroelastomer hr hour(s)
fl fluid HTST high temperature short-time
flamm. flammable, flammability pasteurization
flex. flexural HEUR hydrophobically modified ethoxylate
FNB Food and Nutrition Board urethane
f.p. freezing point HVAC heating, ventilation, air conditioning
FP French Pharmacopoeia HVP hydrolyzed vegetable protein
FR flame retardant hyd. hydroxyl
FR-ABS flame retardant ABS hydrog. hydrogenated
FRP fiberglass-reinforced plastics Hz hertz
F-T Fischer-Tropsch IARC International Agency for Research on
ft foot, feet Cancer (United Nations)
f.w. formula weight i.b.p. initial boiling point
G giga
Handbook of Pharmaceutical Additives, Third Edition ix