Nilotinib EP Impurity A, also known as Nilotinib Related Compound A, in various pharmacopoeias, is a highly characterized standard. It meets strict regulatory requirements set by USP, EMA, JP, and BP, making it a crucial component in Abbreviated New Drug Applications (ANDA), New Drug Applications (NDA), and the commercial production of Nilotinib.
References
Kondra, S. B., et al. “A Validated Stability-Indicative UPLC Method for Nilotinib Hydrochloride for the Determination of Process-Related and Degradation Impurities.” Journal of Chromatographic Science, vol. 52, no. 8, Sept. 2013, pp. 880–85, https://doi.org/10.1093/chromsci/bmt134.
Tanaka, Chiaki, et al. “Effects of Rifampin and Ketoconazole on the Pharmacokinetics of Nilotinib in Healthy Participants.” The Journal of Clinical Pharmacology, vol. 51, no. 1, Jan. 2011, pp. 75–83, https://doi.org/10.1177/0091270010367428.
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