Imatinib - NDSRI's
References
FAQ's
References
- Zimmermann, Juerg, Pyrimidin derivatives and process for their preparation, Ciba-Geigy A.-G., Switzerland, EP564409B1, January 19, 2001
- Widmer, N.; Beguin, A.; Rochat, B.; Buclin, T.; Kovacsovics, T.; Duchosal, M. A.; Leyvraz, S.; Rosselet, A.; Biollaz, J.; Decosterd, L. A., Determination of imatinib (Gleevec) in human plasma by solid-phase extraction-liquid chromatography-ultraviolet absorbance detection, Journal of Chromatography B: Analytical Technologies in the Biomedical and Life Sciences, Volume: 803, Issue: 2, Pages: 285-292, 2004
Frequently Asked Questions
How do regulatory authorities monitor and ensure compliance with impurity limits in Imatinib?
Regulatory authorities conduct inspections of manufacturing facilities, review data from quality-control tests and assess compliance with regulatory guidelines to monitor impurity levels in Imatinib. They may also conduct post-market surveillance and sampling to verify ongoing compliance.
Are there any specific Imatinib impurities that require special attention?
Some impurities in Imatinib, such as genotoxic impurities, receive special attention due to their potential to cause DNA damage and adverse health effects. Manufacturers have robust control strategies to minimize genotoxic impurities and ensure their levels are within acceptable limits.
Which solvent help in analyzing Imatinib impurities?
DMSO or water are the solvents commonly used when analyzing many impurities in Imatinib.
How should Imatinib impurities be stored in terms of temperature?
The recommendation is to store Imatinib impurities at room temperature, within 2-8 °C.
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