USP/NF Listing of Lubrizol Polymers

When Lubrizol's "traditional" polymers were originally proposed to the U.S. Pharmacopeia/National Formulary (USP/NF), mucilage viscosity and residual solvent levels differentiated the various compendial products. These traditional polymers were all polymerized in benzene solvent. However, over time Lubrizol has expanded its product offering to include products polymerized in more toxicologically preferred solvents such as ethyl acetate or a cosolvent mixture of ethyl acetate and cyclohexane.

When the toxicologically preferred solvent products were first introduced, USP agreed that Lubrizol could utilize the same generic compendial name that was initially used for the benzene grade products. Since the traditional and toxicologically preferred solvent polymers have the identical raw materials and nearly identical performance, only a product trade name change was needed, but not a compendial name change. The nomenclature difference between the compendial and product trade name has been a source of confusion because the NF Carbomer designation has historically applied to more than one Carbopol® product where chemical similarities exist (e.g. Carbomer 940 applied to Carbopol® 940 NF polymer and Carbopol® 980 NF polymer).

In order to minimize this confusion, umbrella monographs have been developed to separate Carbomer products that are manufactured without the use of benzene as a polymerization solvent. Lubrizol's pharmaceutical grade products are currently listed in USP/NF with the following designations:

 

USP/NF Compendial Name Lubrizol Product Trade Name Comments
Carbomer 934 Carbopol® 934 NF polymer The monographs called Carbomer XXX are assigned to Lubrizol products manufactured with the use of benzene.
Carbomer XXX refers to the Carbopol® polymer product number designation. For example, Carbopol® 940 polymer is currently listed in theUSP/NF as Carbomer 940.
Carbomer 934P Carbopol® 934P NF polymer
Carbomer 940 Carbopol® 940 NF polymer
Carbomer 941 Carbopol® 941 NF polymer
Carbomer 1342 Carbopol® 1342 NF polymer
Carbomer Homopolymer
Type A Carbopol® 71G NF polymer
Carbopol® 971P NF polymer
Carbopol® 981 NF polymer
On January 1, 2006 the Carbomer Homopolymer monograph became effective in USP 29-NF 24. It is one of the umbrella monographs that separates the Carbomer products based on polymer structure and applies to homopolymer products that are not polymerized in benzene.
As noted in USP 29-NF 24, the monograph includes a delayed implementation date up to January 1, 2011. Prior to January 1, 2011 the current practice of labeling products as Carbomer 941, Carbomer 934P, Carbomer 934 or Carbomer 940 may be continued.
The Carbomer Homopolymer monograph includes three categories of carbomers (Type A, Type B and Type C) which differ by viscosity range.
Type B Carbopol® 974P NF polymer
Carbopol® 5984 EP polymer
Type C Carbopol® 980 NF polymer
Carbomer Copolymer
Type A Pemulen™ TR-2 NF polymer In April, 2002 the Carbomer Copolymer monograph became effective in USP 25-NF 20. It is one of the umbrella monographs that separates the Carbomer products based on polymer structure and applies to copolymer products that are not polymerized in benzene.
The Carbomer Copolymer monograph includes three categories of carbomers (Type A, Type B and Type C) which differ by viscosity range.
Type B Pemulen™ TR-1 NF polymer
Type C No commercial product currently offered
Carbomer Interpolymer
Type A Carbopol® Ultrez 10 NF polymer In April, 2002 the Carbomer Interpolymer monograph became effective in USP 25-NF 20. It is one of the umbrella monographs that separates the Carbomer products based on polymer structure and applies to interpolymer products that are not polymerized in benzene.
The Carbomer Interpolymer monograph includes three categories of carbomers (Type A, Type B and Type C) which differ by viscosity range.
Type B Carbopol® ETD 2020 NF polymer
Type C No commercial product currently offered
Polycarbophil Noveon® AA-1 Polycarbophil USP