Neratinib - NDSRI's
References
FAQ's
References
- Tsou, Hwei-Ru; Overbeek-Klumpers, Elsebe G.; Hallett, William A.; Reich, Marvin F.; Floyd, M. Brawner; Johnson, Bernard D.; Michalak, Ronald S.; Nilakantan, Ramaswamy; Discafani, Carolyn; Golas, Jonathan; et al, Optimization of 6,7-Disubstituted-4-(arylamino)quinoline-3-carbonitriles as Orally Active, Irreversible Inhibitors of Human Epidermal Growth Factor Receptor-2 Kinase Activity, Journal of Medicinal Chemistry, Volume: 48, Issue: 4, Pages: 1107-1131, 2005
- Wania, Tanveer A.; Zargar, Seema; Ahmad, Ajaz, Ultra performance liquid chromatography tandem mass spectrometric method development and validation for determination of neratinib in human plasma, South African Journal of Chemistry, Volume: 68, Pages: 93-98, 2015
Frequently Asked Questions
Why is it essential to control impurities in Neratinib?
Controlling impurities in Neratinib is crucial to ensure their quality, safety, and efficacy.
What is the acceptable limit for Neratinib impurities?
Regulatory agencies like the US FDA, EMA, and ICH establish acceptable limits for impurities in Neratinib. Their limit may vary depending on the impurity level, ensuring that Neratinib meets stringent standards.
How are Neratinib impurities controlled during the manufacturing process of the drug?
Impurities in Neratinib are controlled during the synthetic process by implementing good manufacturing practices (GMP) and using appropriate analytical methods for quantification.
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