Thomas Tice, Richard Creekmore^,, Whitney Moro^,, Peng Zhang, Hong Wang, Catherine Sheehan

Correspondence should be addressed to: Peng Zhang, Principal Scientist, US Pharmacopeia, 12601 Twinbrook Parkway, Rockville, MD 20852-1790; tel: 301.692.3454; e-mail: pgz@usp.org.

In PF 48(2) [Mar.–Apr. 2022], the USP LG Polymer Joint Subcommittee (JS) published a Stimuli article proposing a nomenclature architecture and naming system for lactide (or lactic acid) and/or glycolide (or glycolic acid) polymer (LG polymer) pharmaceutical excipients, A Practical Approach to Compendial Nomenclature and Testing For Lactide and Glycolide Polymers and Related Polymeric Excipients. The goal of that article was to support individual monographs and umbrella monographs for LG polymers by reviewing their synthesis, structure and function relationship, formulation application, and analytical testing of pharmaceutical LG polymers.

USP received comments from the public on that Stimuli article. The present article is focused on USP’s responses to those comments. In addition, this article presents corrections to a few LG polymer structures shown in the PF 48(2) article, clarifications regarding performance-related tests of LG polymers and USP’s scope of work for LG polymers, and updates on USP’s recent activities pertaining to LG polymers.