Lubrizol’s pharmaceutical grade acrylic acid-based polymers are all manufactured according to cGMP standards in ISO 9001 certified facilities. Lubrizol cGMP compliant facilities are located in Calvert City, Kentucky and Kallo, Belgium.

Lubrizol works with all relevant regulatory bodies in order to establish and maintain the global pharmacopeial status of its pharmaceutical ingredients. Lubrizol’s pharmaceutical grade carbomers are listed in monographs of the following international compendia:

U.S. Pharmacopeia/National Formulary (USP/NF)
European Pharmacopeia (Ph. Eur.)
Japanese Pharmaceutical Excipients (JPE) Listing (Based on customer request, Lubrizol certifies select lots of product against the JPE Carboxyvinyl Polymer Monograph)
Chinese Pharmacopeia (ChP) (Lubrizol certifies select lots of product shipped to China against the ChP Carbomer Homopolymer Monograph)
India Pharmacopeia (IP)

Additionally, Lubrizol supports its pharmaceutical ingredients with Drug Master Files (DMFs) in the United States and China. Regulatory excipient dossiers may be available to support drug applications in Europe and other regions.

Pharmacopoeia Monograph Compendial Name
Product Trade Name	Polymerization Solvent	United States (USP/NF)	Europe (Ph. Eur.)	Japan¹ (JPE)	China (ChP)²	India (IP)
Carbopol^® Polymers (homopolymers)
71G NF	Ethyl acetate	Carbomer Homopolymer Type A	Carbomers	Carboxyvinyl Polymer	Carbomer Homopolymer	Carbomers
971P NF	Ethyl acetate	Carbomer Homopolymer Type A	Carbomers	Carboxyvinyl Polymer	Carbomer Homopolymer	Carbomers
974P NF	Ethyl acetate	Carbomer Homopolymer Type B	Carbomers	Carboxyvinyl Polymer	Carbomer Homopolymer	Carbomers
980 NF	Cosolvent³	Carbomer Homopolymer Type C	Carbomers	Carboxyvinyl Polymer	Carbomer Homopolymer	Carbomers
981 NF	Cosolvent³	Carbomer Homopolymer Type A	Carbomers	Carboxyvinyl Polymer	Carbomer Homopolymer	Carbomers
5984 EP	Cosolvent³	Carbomer Homopolymer Type B	Carbomers	Carboxyvinyl Polymer	Carbomer Homopolymer	Carbomers
Carbopol^® Polymers (benzene grade)
934 NF	Benzene	Carbomer 934		Carboxyvinyl Polymer
934P NF	Benzene	Carbomer 934P		Carboxyvinyl Polymer
940 NF	Benzene	Carbomer 940		Carboxyvinyl Polymer
941 NF	Benzene	Carbomer 941		Carboxyvinyl Polymer
1342 NF	Benzene	Carbomer 1342
Carbopol^® Polymers (interpolymers)
ETD 2020 NF	Cosolvent³	Carbomer Interpolymer Type B
Ultrez 10 NF	Cosolvent³	Carbomer Interpolymer Type A
Pemulen™ Polymers
TR-1 NF	Cosolvent³	Carbomer Copolymer Type B
TR-2 NF	Cosolvent³	Carbomer Copolymer Type A
Noveon^® Polycarbophil
AA-1 USP	Ethyl acetate	Polycarbophil

Based on customer request, Lubrizol certifies select lots of product against the JPE Carboxyvinyl Polymer Monograph.
Lubrizol certifies select lots of product shipped to China against the ChP Carbomer Homopolymer Monograph
Cosolvent system made using cyclohexane and ethyl acetate

The USP/NF Carbomer Homopolymer, Copolymer, and Interpolymer monographs include three categories of carbomers (Type A, Type B and Type C) which differ by viscosity range

Lubrizol does not recommend the use of a benzene polymerized carbomer in a pharmaceutical formulation. The following table shows recommended substitutes for the benzene grade Carbopol products based on viscosity criteria. The substitute products are polymerized in either ethyl acetate or a cosolvent mixture of ethyl acetate and cyclohexane. If a substitution is made in a pharmaceutical formulation, it is recommended that key performance properties be ascertained, and regulatory considerations be taken into account. Depending on the desired dosage requirements, other Carbopol polymers may be suitable alternatives.

Benzene Grade Carbopol^® Polymers	Recommended Non-Benzene Grade Carbopol^® or Pemulen™ Polymers
934 NF Polymer^®Carbopol	Carbopol^® 974P NF and Carbopol^® 5984 EP Polymers
Carbopol^® 934P NF Polymer	Carbopol^® 974P NF and Carbopol^® 5984 EP Polymers
Carbopol^® 940 NF Polymer	Carbopol^® 980 NF Polymer
Carbopol^® 941 NF Polymer	Carbopol^® 971P NF and Carbopol^® 981 NF Polymers
Carbopol^® 1342 NF Polymer	Pemulen™ TR-1 NF Polymer

Global Regulatory Status

US FDA Inactive Ingredients Status

Global Regulatory Status of Lubrizol’s Carbopol®, Pemulen™, and Noveon® Polymers