BRIEFING

 Buprenorphine Injection. Because there is no existing USP monograph for this drug product, a new monograph based on validated methods of analysis is being proposed. On the basis of comments received, the proposal previously published in PF 46(6) [Nov.–Dec. 2020] has been canceled and is being replaced with this new proposal. The liquid chromatographic procedures in the Assay and the test for Organic Impurities are based on analyses performed with the Sunfire C18 brand of column with L1 packing. The typical retention times for buprenorphine in the Assay and the test for Organic Impurities are about 3 and 8 min, respectively.

 (SM2: W. Yang)

 Case ID—SUB-1428