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Yes, stability studies are conducted to monitor impurity levels in Darunavir over its shelf life, ensuring the levels of impurities remain within acceptable limits.
Impurity control is an ongoing process that starts from the early development stages and continues throughout the entire lifecycle of Darunavir, including post-marketing surveillance.
Acetonitrile is a solvent used in analyzing many impurities in Darunavir.
Darunavir 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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