Niraparib - NDSRI's
References
FAQ's
References
- Jones, Philip; Ontoria Ontoria, Jesus Maria; Scarpelli, Rita; Schultz-Fademrecht, Carsten, Amide substituted indazoles as poly(ADP-ribose)polymerase (PARP) inhibitors, WO2008084261A1, July 17, 2008, Istituto Di Ricerche Di Biologia Molecolare P. Angeletti SpA, Italy
- van Andel, L.; Zhang, Z.; Lu, S.; Kansra, V.; Agarwal, S.; Hughes, L.; Tibben, M. M.; Gebretensae, A.; Rosing, H.; Schellens, J. H. M.; et al, Liquid chromatography-tandem mass spectrometry assay for the quantification of niraparib and its metabolite M1 in human plasma and urine, Journal of Chromatography B: Analytical Technologies in the Biomedical and Life Sciences, Volume: 1040, Pages: 14-21, 2017 DOI: (10.1016/j.jchromb.2016.11.020)
Frequently Asked Questions
What are the conditions under which Niraparib impurities form in the drug product?
High temperature, humidity, and improper storage conditions cause the formation of Niraparib impurities in the drug product.
What happens if Niraparib impurities remain in the drug?
If Niraparib impurities remain in the drug, it will cause harmful effects to patients and may even lead to death.
Why is it essential to have an impurity profile for Niraparib impurities?
It is essential to have an impurity profile to detect any changes in the drug substance or modifications in raw materials that will impact the drug’s safety and efficacy.
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