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Regulatory authorities, such as the United States Pharmacopeia (USP) and the International Conference on Harmonization (ICH), provide guidelines and limits for impurity levels in pharmaceutical products, including Dasatinib.
Impurities in Dasatinib are identified and characterized using analytical techniques such as high-resolution mass spectrometry (HRMS) and comparison with reference standards.
The steps to minimize impurity formation during Dasatinib synthesis are optimizing reaction conditions, controlling temperature and pH, using appropriate catalysts and reagents, and implementing effective purification techniques.
Dasatinib 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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