BRIEFING

 Mesna Injection. Because there is no existing USP monograph for this drug product, a new monograph is being proposed. On the basis of comments received, the proposal previously published in PF 46(4) [Jul.–Aug. 2020] is canceled and replaced with this new proposal. The liquid chromatographic procedures in the Assay and the Organic Impurities test are based on validations performed with the Synergi Fusion-RP brand of column with L1 packing. The typical retention time for mesna is about 4 min. Changes to the PF 46(4) proposal to address comments received include removing the test for Content of Benzyl Alcohol and revising the acceptance criterion for “Any unspecified degradation product” in the Organic Impurities test from NMT 0.3% to NMT 0.2%.

 (SM2: W. Yang)

 Correspondence Number—C293798