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Impurities in Lenvatinib can form during the manufacturing process, storage conditions, or due to interactions with other components. Factors such as temperature, pH, and exposure to light can contribute to impurity formation.
Regulatory authorities, such as the United States Pharmacopeia (USP) or the International Council for Harmonization (ICH), provide guidelines on acceptable limits for impurities in Lenvatinib to ensure its safety and quality.
Impurities in Lenvatinib have the potential to impact its efficacy or safety. Some may have toxic effects or alter the drug's therapeutic properties, making it crucial to control them within acceptable limits.
The recommendation is to store Lenvatinib impurities at a controlled room temperature, within 2-8 °C.
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