USP completes maltitol sodium monograph revision

The US Pharmacopeia (USP) has published the proposed analytical method for detecting diethylene glycol (DEG) and ethylene glycol (EG) contamination in the excipient maltitol sodium.

Earlier, USP revised the compendial methods for four other high-priority excipients - propylene glycol, sorbitol solution, sorbitol sorbitan solution, and noncrystallising sorbitol solution - at the request of the US Food and Drug Administration (FDA).

The move comes after a number of cases of DEG and EG contamination which have caused hundreds of fatalities over recent decades, most recently a tragic episode between November 2008 and January 2009 in which 84 children in Nigeria died after ingesting teething syrup contaminated with DEG.

The new maltitol sodium method lays out limits for each contaminant at a level of not more than 0.10 per cent in the identification test and is consistent with earlier methods published for the other four at-risk excipients.

USP notes there will not be a subsequent formal comment period, only the final official Revision Bulletin. The deadline for informal comments is March 2, 2010.