1-Pyrrolidineacetamide, a-ethyl-2-oxo-4-propyl-, (αS,4R)-;
(S)-2-[(R)-2-Oxo-4-propylpyrrolidin-1-yl]butanamide [357336-20-0]
BRIEFING
Brivaracetam. Because there is no existing USP monograph for this drug substance, a new monograph based on validated methods of analysis is proposed.
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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.
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The liquid chromatographic procedure in the test for Stereoisomeric Purity is based on validations performed with the Chiralpak AD brand of column with L51 packing. The typical retention time for brivaracetam is about 19 min.
Description and solubility information: White to off-white, crystalline powder. Very soluble in water, in ethanol, in methanol, and in glacial acetic acid; freely soluble in acetonitrile and in acetone; soluble in toluene; very slightly soluble in n-hexane.
(SM4: D. Singh)
Correspondence Number—C271455
USP REFERENCE STANDARDS FOR PURCHASE
USP Brivaracetam Related Compound B RSUSP Brivaracetam Related Compound C RS
USP Brivaracetam RS
USP Brivaracetam Related Compound A RS