Global Regulatory Status of Lubrizol’s Polymers

Lubrizol’s pharmaceutical grade 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        
  1. Based on customer request, Lubrizol certifies select lots of product against the JPE Carboxyvinyl Polymer Monograph.
  2. Lubrizol certifies select lots of product shipped to China against the ChP Carbomer Homopolymer Monograph
  3. 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.