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HPLC separates impurities based on their chemical and physical properties, such as molecular weight, polarity, and charge. The separated impurities are then detected using a UV detector or a mass spectrometer.
Mass spectrometry is a sensitive technique that can detect and quantify impurities in Varenicline at low levels. It provides information on the molecular weight and structure of the impurities that helps in their identification and characterization.
Methanol or Acetonitrile is a solvent used in analyzing many impurities in Varenicline.
Varenicline 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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