Sunitinib - NDSRI's
References
FAQ's
References
Frequently Asked Questions
Why is the presence of impurities a concern in Sunitinib?
Impurities in Sunitinib can affect its quality, safety, and efficacy. 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.
How are impurities in Sunitinib detected and quantified?
Impurities in Sunitinib are detected and quantified using reversed-phase (RP) ultra-high-performance liquid chromatography. This method will allow for accurate identification and quantification of impurities.
What steps can control impurity levels in Sunitinib during manufacturing?
To maintain control over impurity levels in Sunitinib, several strategies, like using high-quality starting materials, optimizing synthesis, comprehensive quality-control tests, and continuously monitoring impurity levels, must be implemented at different stages of the manufacturing process.
What are the temperature conditions required to store Sunitinib Impurities?
Sunitinib 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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