Brivaracetam EP Impurity D

Development of an effective novel validated stability-​indicating HPLC method for the resolution of brivaracetam stereoisomeric impurities
By Baksam, Vijayakumar; N, Saritha; Pocha, Vasundara Reddy; Chakka, Veera Babu; Ummadi, Ravindra Reddy; Kumar, Pramod
From Chirality (2020), 32(9), 1208-1219
 
HPLC studies on degradation behavior of brivaracetam and development of validated stability - indicating HPLC assay method
By Mali, N. V.; Mhaske, D. V.
From International Journal of Science and Research Methodology (2016), 4(3), 43-57
 

Brivaracetam EP Impurity D is chemically (2S)-2-[(4R)-2-oxo-4-propylpyrrolidin-1-yl]butanoic acid (as per EP) ; (S)-2-[(R)-2-Oxo-4-propylpyrrolidin-1-yl]butanoic acid (as per USP). It is also known as Brivaracetam USP Related Compound D ; Brivaracetam Acid. Brivaracetam EP Impurity D is supplied with detailed characterization data compliant with regulatory guideline. Brivaracetam EP Impurity D can be used for the analytical method development, method validation (AMV), Quality Controlled (QC) application for Abbreviated New Drug Application (ANDA) or during commercial production of Brivaracetam.

The product can be used as reference standards and further traceability against pharmacopeial standards (USP or EP) can be provided based on feasibility. SynZeal products are for analytical purpose only and not for human use.