Ibrutinib - NDSRI's
References
FAQ's
References
- Honigberg, Lee; Verner, Erik; Pan, Zhengying, “Inhibitors of bruton's tyrosine kinase”, Pharmacyclics, Inc., United States, US7514444B2, April 7, 2009
- Konduru, Naresh; Gundla, Rambabu; Katari, Naresh Kumar; Paidikondala, Kalyani; Reddy, Annem Siva; Jagadabi, Varaprasad, “Development and Validation of a Stability-indicating Method for Ibrutinib: Identification and Separation of Degradation Products, Known and Genotoxic Impurities Using RP-HPLC/PDA and QDa Mass Detectors”, Analytical Chemistry Letters, Volume: 10, Issue: 1, Pages: 113-136, 2020
- Rood, Johannes J. M. ; van Hoppe, Stephanie; Schinkel, Alfred H.; Schellens, Jan H. M.; Beijnen, Jos H.; Sparidans, Rolf W.,” Liquid chromatography-tandem mass spectrometric assay for the simultaneous determination of the irreversible BTK inhibitor ibrutinib and its dihydrodiol-metabolite in plasma and its application in mouse pharmacokinetic studies”, Journal of Pharmaceutical and Biomedical Analysis, Volume: 118, Pages: 123-131, 2016
Frequently Asked Questions
How are isomeric impurities formed in Ibrutinib?
Isomeric impurities in Ibrutinib occur due to the presence of stereoisomers during the synthetic process.
What are degradant impurities in Ibrutinib?
Degradant impurities in Ibrutinib result from the breakdown of the drug substance due to factors such as hydrolysis, oxidation, or photolysis.
What are residual solvents in Ibrutinib?
The residual solvents in Ibrutinib are the solvents used during the synthetic process but remain in the final product in small amounts.
How are Ibrutinib impurities identified and characterized?
The impurities in Ibrutinib are identified and characterized through analytical methods such as liquid chromatography-mass spectrometry (LC-MS), etc.
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