BRIEFING

 dl-Lactide Homopolymer 14000 Acid. Because there is no existing NF monograph for this excipient, a new monograph based on validated methods of analysis is proposed. Please see the background information for developing the monographs for lactide and glycolide polymers and related polymeric excipients, including this monograph, in the Stimuli article A Practical Approach to Compendial Nomenclature and Testing For Lactide and Glycolide Polymers and Related Polymeric Excipients, which appeared in PF 48(2) [Mar.–Apr. 2022]. USP published a second Stimuli article on lactide (or lactic acid) and/or glycolide (or glycolic acid) polymers (LG polymers), USP Responses to Comments on Stimuli Article: "A Practical Approach to Compendial Nomenclature and Testing for Lactide and Glycolide Polymers and Related Polymeric Excipients", in PF 49(6) [Nov.–Dec. 2023]. The second article offers USP’s responses to the comments received on the first 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. The proposal of the first LG polymer monograph for dl-Lactide and Glycolide (50:50) Copolymer 12000 Acid was published in PF 48(3) [May–Jun. 2022]. The proposal of the second LG polymer monograph for dl-Lactide and Glycolide (50:50) Copolymer 12000 Ethyl Ester was published in PF 48(6) [Nov.–Dec. 2022]. The proposal of the third LG polymer monograph for dl-Lactide and Glycolide (50:50) Copolymer 46000 Acid was published in PF 49(5) [Sep.–Oct. 2023].

 The test for Limit of dl-Lactide is based on a validated gas chromatographic method of analysis performed with the Agilent DB-225 brand of column or Restek Rtx-225 brand of column with G7 phase. The typical retention times for dl-lactide and γ-decalactone are approximately 5.7 and 8.1 min, respectively.

 (CE: P. Zhang)

 Case-ID—SUB-268