Product Regulatory Information

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)
  • Japanese
  • European Pharmacopeia (Ph. Eur.)
  • Pharmaceutical Excipients (JPE) Listing (Based on customer request, Lubrizol certifies select lots of product against the JPE Carboxyvinyl Polymer Monograph)  

Additionally, Lubrizol supports its pharmaceutical ingredients with Drug Master Files (DMFs) in the United States and Europe. 

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: