BRIEFING

 dl-Lactide and Glycolide (50:50) Copolymer 46000 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]. The proposal of the first lactide (or lactic acid) and/or glycolide (or glycolic acid) polymer (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 test for Limit of dl-Lactide and Glycolide 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, glycolide, and γ-decalactone are approximately 5.7, 6.9, and 8.1 min, respectively.

 (CE: P. Zhang)

 Correspondence Number—C315829