Carbopol® 981 NF Polymer

Carbomer Homopolymer Type A USP NF

Applicable synonyms for Carbopol^® 981 NF polymer: Carbomer, carboxypolymethylene

Polymerization/residual solvent: Cosolvent mixture of ethyl acetate and cyclohexane

Key Features

• Emulsion and suspension stabilizer

Additional Features

• Bioadhesive agent
• Thickener and rheology modifier 

Recommended for Use in the Following Dosage Forms

• Semisolids & gels
  

Recommended for Use in the Following Markets / Routes of Administration

• Topical drug delivery
• Ophthalmic drug delivery
  

Carbopol® 981 NF polymer meets the limits cited in the current edition of the following monographs: 

• United States Pharmacopeia/National Formulary (USP/NF) monograph for Carbomer Homopolymer Type A
• European Pharmacopeia (Ph. Eur.) monograph for Carbomers
• India Pharmacopeia (IP) monograph for Carbomers
• China Pharmacopeia (ChP) monograph for Carbomer Homopolymer
• Japanese Pharmaceutical Excipients (JPE) Monograph for Carboxyvinyl Polymer 
  

Usage Levels 

• Topical 0.5-3 wt%
  

Note on Toxicity Testing

The toxicity of carbomers has been summarized by the Cosmetic Ingredient Review Expert Panel in their assessment of the safety of the carbomers for cosmetic ingredients. This assessment and subsequent toxicology testing have demonstrated a low toxicity and irritation potential. Lubrizol has supporting data for dermal, oral, and ophthalmic toxicology testing for Carbopol 981 NF polymer. Bulletin 2 provides a summary of all toxicology studies for Lubrizol’s pharmaceutical grade polymers.

Additionally, Lubrizol has filed a Type V DMF with FDA. A letter of authorization (LOA) can be issued for FDA drug applications.