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Impurity profiling is essential in identifying and controlling impurities in Pregabalin during manufacturing.
Various analytical methods like High-Performance Liquid Chromatography (HPLC), Liquid Chromatography-mass spectroscopy (LC-MS), etc., help identify impurities in Pregabalin.
Methanol or Acetonitrile is the solvent used for analyzing many impurities in Pregabalin.
Pregabalin impurities are stored at a controlled room temperature between 2-8 ⁰C or as indicated on the Certificate of Analysis (CoA).
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