Nintedanib - NDSRI's
References
FAQ's
References
- Heckel, Armin; Roth, Gerald Juergen; Walter, Rainer; Van Meel, Jacobus; Redemann, Norbert; Tontsch-Grunt, Ulrike; Spevak, Walter; Hilberg, Frank, Substituted indolines which inhibit receptor tyrosine kinases, Boehringer Ingelheim Pharma K.-G., Germany, US6762180B1, July 13, 2004
- Darwish, Hany W.; Attwa, Mohamed W.; Kadi, Adnan A., Rapid validated liquid chromatographic method coupled with Tandem mass spectrometry for quantification of Nintedanib in human plasma, Tropical Journal of Pharmaceutical Research, Volume: 15, Issue: 11, Pages: 2467-2473, 2016
Frequently Asked Questions
Are Nintedanib Impurities harmful?
The impurities do not necessarily imply harm, but their levels and nature need careful regulation. Health authorities set specific limits for impurity levels based on safety and efficacy considerations.
Can Impurities in Nintedanib affect its effectiveness?
Impurities in Nintedanib can affect its effectiveness by altering the drug's pharmacokinetics, pharmacodynamics, or stability. Controlling them ensures the drug maintains its therapeutic potency and delivers the desired outcome.
How are Nintedanib Impurities detected and quantified?
Analytical techniques such as High-Performance Liquid Chromatography (HPLC), Mass Spectrometry (MS) help detect and quantify Nintedanib impurities. These methods enable accurate identification and measurement of impurity levels.
What are the temperature conditions required to store Nintedanib Impurities?
Nintedanib impurities should be stored at a controlled room temperature between 2-8°C or as indicated on the Certificate of Analysis (CoA).
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