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Yes, impurities in Efinaconazole undergo comprehensive toxicological evaluations to determine their potential toxicity and establish safe exposure limits. This assessment ensures patient safety during drug administration.
Some impurities in Efinaconazole can impact its stability over time, potentially leading to degradation or reduced shelf life. Stability studies assess the drug's integrity under various storage conditions.
Impurity profiles for Efinaconazole are regularly reviewed and updated to align with evolving regulatory guidelines, scientific advancements, and emerging safety concerns. These updates help ensure the drug's continued quality and safety.
Efinaconazole 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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