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Impurity profiling is a critical step in Apixaban manufacturing as it helps identify, characterize, and quantify impurities present in the drug substance. It helps to optimize the manufacturing process and ensure the drug’s quality, safety, and efficacy.
Common impurities found in Apixaban include degradation products and residual solvents and may result from the manufacturing process, such as unreacted starting materials, reagents, or by-products.
Apixaban impurities are removed through purification steps such as recrystallization, distillation, or chromatography.
Apixaban 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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