18595-18-1Nilotinib EP Impurity B

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Catalogue No.:	VE009189
CAS No.:	18595-18-1
Mol. Formula:	C9H11NO2
Mol. Weight:	165.19 g/mol

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Additional information on CAS 18595-18-1

Parent drug

Nilotinib

IUPAC Name

Methyl 3-amino-4-methylbenzoate

Pharmacopoeial Synonyms

Nilotinib Related Compound B

Other Synonyms

3-Amino-p-toluic Acid Methyl Ester; 2-Methyl-5-methoxycarbonylaniline; 3-Amino-4-methylbenzoic Acid Methyl Ester

Smiles

COC(=O)c1ccc(C)c(N)c1

InChI

InChI=1S/C9H11NO2/c1-6-3-4-7(5-8(6)10)9(11)12-2/h3-5H,10H2,1-2H3

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 B, also designated Nilotinib Related Compound B, corresponds to a low-molecular-weight aromatic aminoalcohol with CAS 18595-18-1, molecular formula C9H11NO2, and molecular weight 165.19 g/mol. The structure is consistent with a synthetic intermediate or process-related byproduct associated with construction of substituted benzylamine motifs rather than a nitrosamine class impurity. Its evaluation typically relies on orthogonal characterization by LC-MS/MS, high-resolution MS, and NMR, with GC-MS useful after derivatization when volatility permits. In a regulatory context, this impurity is controlled as a specified related substance under impurity profiling principles.