Apixaban - NDSRI's
References
FAQ's
References
- Pinto, Donald; Quan, Mimi; Orwat, Michael; Li, Yun-Long; Han, Wei; Qiao, Jennifer; Lam, Patrick; Koch, Stephanie, Lactam-Containing Compounds And Derivatives Thereof As Factor Xa Inhibitors, Bristol-Myers Squibb Company, United States, EP1427415B1, August 12, 2009
- Delavenne, Xavier; Mismetti, Patrick; Basset, Thierry, Rapid determination of apixaban concentration in human plasma by liquid chromatography/tandem mass spectrometry: Application to pharmacokinetic study, Journal of Pharmaceutical and Biomedical Analysis, Volume: 78-79, Pages: 150-153, 2013
Frequently Asked Questions
What is the role of impurity profiling in Apixaban manufacturing?
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.
What are the common impurities found in Apixaban?
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.
How are Apixaban impurities removed?
Apixaban impurities are removed through purification steps such as recrystallization, distillation, or chromatography.
What are the temperature conditions required to store Apixaban impurities?
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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