A USP Stimuli article to the revision process, titled "The Complexity of Setting Compendial Specifications for Excipient Composition and Impurities", is published in Pharmacopeial Forum (PF) 44(3) [May-June 2018].
The USP Stimuli article discusses the challenges with setting specification for pharmaceutical excipients, specifically; there is no clear consensus on how to address excipient composition and impurities.
IPEC Europe recommends to its members to read this USP Stimuli article and, as a follow up, to answer to this USP 10-minutes survey.
USP is asking for your feedback on how specifications for pharmaceutical excipient composition and impurities should be set.
The results of this survey will help USP better identify and address stakeholder overall needs and challenges regarding USP’s current written standards on impurities in excipients.
Comments to the article are welcome by contacting the author below:
Senior Scientific Liaison
US Pharmacopeial Convention
12601 Twinbrook Parkway, Rockville, MD 20852-1790
Source : http://www.usp.org/our-work/excipients/stimuli-article-2018