Nilotinib EP Impurity A
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Documentation

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Includes: HPLC, MASS/LC-MS, 1H NMR, FT-IR, Potency, Structure Elucidation Report (SER), and additional analytical data depending on the product.

641571-11-1Nilotinib EP Impurity A

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Catalogue No.:VE006046
CAS No.:641571-11-1
Mol. Formula:C11H10F3N3
Mol. Weight:241.22 g/mol

Additional information on CAS 641571-11-1

Parent drug

Nilotinib

IUPAC Name

3-(4-methyl-1H-imidazol-1-yl)-5-(trifluoromethyl)aniline

Pharmacopeial Synonyms

Nilotinib Related Compound A

Synonyms

Nilotinib Amino Impurity

Smiles

NC1=CC(C(F)(F)F)=CC(N2C=C(C)N=C2)=C1

InChI

NC1=CC(C(F)(F)F)=CC(N2C=C(C)N=C2)=C1

Description

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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