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Frequently Asked Questions
Impurities in Brivaracetam can be controlled by different means, such as optimizing the manufacturing process, using high-quality raw materials, implementing good manufacturing practices (GMP), and storing the drug under appropriate conditions.
Impurity limits for Brivaracetam are determined based on safety and efficacy. The regulatory authorities, such as the USP and ICH, govern the impurity limits.
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.
Acetonitrile or Methanol are solvents used for analyzing many impurities in Brivaracetam.
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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