IPEC e-newsletter - Excipients Insight October 2018 - 31-10-18


Inside this issue


USP seeks input on specifications for excipient composition and impurities

Setting specifications for pharmaceutical excipients is complex due to the vast array of materials that are used in drug product formulation, and is becoming increasingly more complicated with the need to update excipient monographs through the introduction of modern analytical techniques.

To help address the challenge in ongoing revisions, the US Pharmacopeial Convention (USP) has published a stimuli article to discuss the issues with setting specification for excipients – including the lack of clear consensus on how to address excipient composition and impurities – and has launched a survey to collect feedback from stakeholders on how specifications for excipient composition and impurities should be set.

IPEC Europe recommends that its members read the USP stimuli article and, as a follow up, to answer to the survey, which should take around 10 minutes to complete. 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 on the article are welcome by contacting the author below:

Galina Holloway

Senior Scientific Liaison

US Pharmacopeial Convention

12601 Twinbrook Parkway, Rockville, MD 20852-1790


e-mail: gvh@usp.org




Copyright © 2005 - 2018 IPEC Europe - International Pharmaceutical Excipients Council