Bosutinib
References
- Boschelli, Diane Harris; Wang, Yanong Daniel; Johnson, Steve Lawrence; Berger, Dan Maarten, Process for the preparation of 7-substituted-3 quinolinecarbonitriles, Wyeth Holdings Corporation, United States, US6780996B2, August 24, 2004
- Chaudhari, Vidya L.; Kulkarni, Amol A., RP-HPLC method for estimation of Bosutinib in bulk form as per ICH guidelines, World Journal of Pharmaceutical Research, Volume: 5, Issue: 12, Pages: 417-424, 2016
Frequently Asked Questions
Why is it essential to control Bosutinib impurities?
Controlling impurities in Bosutinib is essential because they can affect drug safety and efficacy. They can also cause adverse reactions and impact the quality of the drug product.
How are Bosutinib impurities controlled during manufacturing?
Bosutinib impurities are controlled during manufacturing using validated analytical methods, monitoring reaction conditions, and implementing quality control measures.
Can all Bosutinib impurities be removed?
It may not be possible to remove all Bosutinib impurities. However, their control is within acceptable limits through rigorous manufacturing and quality control processes.
What are the temperature conditions required to store Bosutinib impurities?
Bosutinib 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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