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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.

2458-12-0Nilotinib EP Impurity C

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Catalogue No.:	VE009190
CAS No.:	2458-12-0
Mol. Formula:	C8H9NO2
Mol. Weight:	151.16 g/mol

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Additional information on CAS 2458-12-0

Parent drug

Nilotinib

IUPAC Name

3-Amino-4-methylbenzoic acid

Pharmacopoeial Synonyms

Nilotinib Related Compound C

Other Synonyms

3-Amino-p-toluic Acid; 2-Toluidine-4-carboxylic Acid; 4-Methyl-3-aminobenzoic Acid

Smiles

Cc1ccc(C(=O)O)cc1N

InChI

InChI=1S/C8H9NO2/c1-5-2-3-6(8(10)11)4-7(5)9/h2-4H,9H2,1H3,(H,10,11)

Shipping Condition

Ambient Temperature

Characterization Data (Included)

HPLC, MASS/LC-MS, 1H NMR, FT-IR, Potency, and Structure Elucidation Report (SER).

Additional Characterization Data

QNMR, D2O Exchange, 13C NMR, 13C APT, COSY NMR, NOESY NMR, 15N NMR, HSQC NMR, HMQC NMR, and HMBC NMR. These are available upon request and may be free or subject to additional charges.

Description

Nilotinib EP Impurity C, also known as Nilotinib Related Compound C, CAS 2458-12-0, is a structurally defined small-molecule impurity with formula C8H9NO2 and molecular weight 151.16 g/mol. Its composition is consistent with a pyridine-derived aromatic acid amide intermediate or process-related transformation product rather than a nitrosamine class impurity. In regulatory characterization, such species are evaluated as synthetic byproducts or degradants arising from route-specific side reactions. Trace-level determination generally requires chromatographic separation coupled to LC-MS/MS or high-resolution LC-MS, with confirmatory NMR where needed. Its presence is interpreted within impurity profiling frameworks and ICH Q3A/Q3B control strategies.

References

“Blay, J.-Y., & von Mehren, M. (2011). Nilotinib: A Novel, Selective Tyrosine Kinase Inhibitor. Seminars in Oncology, 38, S3–S9. https://doi.org/10.1053/j.seminoncol.2011.01.016 ‌”