BRIEFING

 Brivaracetam Oral Solution. Because there is no existing USP monograph for this drug product, a new monograph based on validated methods of analysis is proposed. The liquid chromatographic procedure in the Assay and test for Organic Impurities is based on validations performed with the Acquity BEH C18 brand of column with L1 packing. The typical retention time for brivaracetam is about 8 min.

 The proposed test for Identification B, based on thin-layer chromatography, utilizes methylene chloride as a solvent for extraction. USP is trying to reduce the usage of hazardous chemicals in the compendial standards to the extent possible. Stakeholders are encouraged to submit a procedure for identification which utilizes nonhazardous chemicals.

 (SM4: D. Singh)

 Correspondence Number—C271517