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Manufacturers can adopt several strategies to maintain control over impurity levels in Sorafenib. They include using high-quality starting materials, optimizing synthesis and purification processes, implementing comprehensive quality control tests, and continuously monitoring impurity levels at different stages of the manufacturing process.
Inorganic impurities in Sorafenib can be due to the raw materials used during manufacturing, which may include substances such as heavy metals or other contaminants—underscoring the importance of vigilant monitoring and stringent control measures to uphold Sorafenib's quality and safety standards as a pharmaceutical product.
Depending on the type and level of impurities, they can impact the drug's pharmacological activity and stability and pose potential risks to patient health.
Sorafenib 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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