USP Seeks Comments on Four Excipient Monographs

The US Pharmacopeia is revising its monographs for four pharmaceutical excipients: propylene glycol, sorbitol solution, sorbitol sorbitan solution, and noncrystalllizing sorbitol solution. USP posted draft compendial methods for these monographs for public comment.

According to USP, the revisions are part of the organization’s efforts to prevent future diethylene glycol (DEG) and ethylene glycol (EG) adulteration of these excipients. In addition to changing the exipient monographs, USP developed two new impurities reference standards for DEG and EG.

DEG-contaminated glycerin used in the manufacture of acetaminophen syrup in Haiti between November 1995 and June 1996 was responsible for most of the subsequent cases of acute renal failure diagnosed in 86 children, according to the Centers for Disease Control. In 2007, DEG was also discovered in toothpaste originating from China.

Comments on the four excipient monographs are due by August 14, 2009. USP says it also will post a proposed method for maltitol solution in the near future.

See these related PharmTech articles:

FDA Issues Guidance for Testing for DEG-Contaminated Glycerin (ePT newsletter)

Excipient Control Strategies (Primer: A Guide to Managing the Supply Chain, supplement to PharmTech's October 2008 issue)

Excipient Control Strategies in China (CPhI Focus newsletter)