Brivaracetam Tablets
BRIEFING
Brivaracetam Tablets. 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 the 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.
(SM4: D. Singh)
Correspondence Number—C271478
USP REFERENCE STANDARDS FOR PURCHASE
USP Brivaracetam RSUSP Brivaracetam Related Compound A RS
USP Brivaracetam Related Compound D RS