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Brivaracetam
References
FAQ's
References
- Differding, Edmond; Kenda, Benoit; Lallemand, Benedicte; Matagne, Alain; Michel, Philippe; Pasau, Patrick; Talaga, Patrice, 2-Oxo-1-Pyrrolidine Derivatives, Processes For Preparing Them And Their Uses, UCB, S.A., Belgium, WO0162726A2, August 30, 2001
- Vishweshwar, Vavilala; Babu, J. Moses; Muralikrishna, R., Development and validation of stability-indicating UPLC method for the determination of brivaracetam, its related impurities and degradation products, International Journal of Pharmaceutical Sciences and Research, Volume: 9, Issue: 6, Pages: 2315-2327, 2018
Frequently Asked Questions
How are the impurity limits set for Brivaracetam?
Impurity limits for Brivaracetam are determined based on safety and efficacy. The regulatory authorities, such as the USP and ICH, govern the impurity limits.
How are potential impurities identified during the manufacturing process of Brivaracetam?
During manufacturing, analytical tests detect and quantify potential impurities in the Brivaracetam drug substance. These tests include HPLC, LC-GC, NMR, and other methods to ensure the purity of the drug substance.
Which solvent helps in the analysis of Brivaracetam impurities?
Acetonitrile or Methanol are solvents used for analyzing many impurities in Brivaracetam.
What are the temperature conditions required to store Brivaracetam impurities?
Brivaracetam impurities are stored at a controlled room temperature between 2-8 °C or as indicated on the Certificate of Analysis (CoA).
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