Applicable synonyms for Noveon® AA-1 Polycarbophil USP: polycarbophil
Polymerization/Residual solvent: Ethyl acetate (ICH Class 3)
Noveon AA-1 Polycarbophil USP, as well as all oral-grade Carbopol polymers, is solely polymerized in ethyl acetate, which is a toxicologically preferred class III solvent.
Lubrizol has supporting data for dermal, ocular, and oral toxicology testing for Noveon® AA-1 Polycarbophil USP. 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.
|Recommended Retest Date
|2 years after manufacturing date
|In airtight containers, protected from moisture and excessive temperature