A USP Stimuli article to the revision process, titled, “The Complexity of Setting Specifications for Excipient Composition and Impurities”, is published in Pharmacopeial Forum (PF) 44(3) [May-June 2018]. The 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. 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.

Please read the Stimuli article before taking the survey. 

Link to the survey

see also our Basics Chapter