The Complexity of Setting Compendial Specifications for Excipient Composition and Impurities

Pharmaceutical excipients are essential components of most modern dosage forms and play a critical role in the drug product’s development, delivery, effectiveness and stability. Setting specifications for excipients is complex due to the vast array of materials that are utilized in drug product formulation and is becoming increasingly more complicated with the need to update excipient monographs through the introduction of modern analytical techniques. On this page, you can view a Stimuli article and explanatory video produced by USP addressing this issue; comments are welcome through the link below.

Pharmacopeial Forum

Did you know standards for drugs, excipients, and dietary supplements found in the United States Pharmacopeia–National Formulary (USP–NF) are continuously revised through a process involving public participation? The vehicle through which USP publishes its proposed standards revisions for public review and comment is called Pharmacopeial Forum (PF).

The PF is a free electronic publication that is an integral part of the USP standards-setting process. The PF includes the first announcements of planned updates and additions to the USP–NF. This publication also provides the mechanism for the public and the pharmaceutical industry to submit input and commentary to USP.

Stimuli articles

Through PF, you can view and comment on Stimuli, articles on standards development topics authored by the USP Council of Experts, USP staff, or other interested parties on which USP desires public input prior to further development.

PF 44(3), published in May 2018, includes a Stimuli articled titled The Complexity of Setting Compendial Specifications for Excipient Composition and Impurities. A PDF copy of this article is available here for your convenience, but also available with a free login through the PF website. Comments are welcome on this article by contacting the author below:

Galina Holloway, Senior Scientific Liaison 
US Pharmacopeial Convention
12601 Twinbrook Parkway, Rockville, MD 20852-1790

Download Stimuli article:

The Complexity of Setting Compendial Specifications for Excipient Composition and Impurities

PF alert video

Below is a video of Dr. Holloway narrating an overview of this Stimuli article. This video is part of USP’s ongoing PF Alert series, available for free via USP Education. The PF Alert is an enhanced recording briefly highlighting topics presented in the current Pharmacopeial Forum. Available online and bi-monthly when the PF is published, this abbreviated presentation allows you to quickly find your topic(s) of interest and gain valuable insight on the upcoming changes to the USP–NF that may impact your work.

Watch Video