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Nilotinib impurities' control is through strict quality control measures during manufacturing. Regulatory authorities set specific limits for impurity levels that must be adhered to.
Nilotinib impurities can affect its effectiveness by altering the drug's pharmacokinetics, pharmacodynamics, or stability. It is crucial to control and monitor impurities so that the drug maintains its therapeutic potency and delivers the desired therapeutic outcomes.
Nilotinib generics are thoroughly checked for impurities to assure their quality, safety, and efficacy. Comparative studies and thorough quality control help guarantee that generic versions are equal regarding purity and drug efficacy.
Nilotinib impurities should be stored at a controlled room temperature between 2-8°C or as indicated on the Certificate of Analysis (CoA).
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