Nilotinib Impurity 35 CAS CATO-C4X-125635

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-125635
Molecular FormulaC28H21F3N8O2
Molecular Weight558.51 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Nilotinib Impurity 35 CAS CATO-C4X-125635 chemical structure

Description

CATO manufactures Nilotinib Impurity 35 under ISO 17034:2016 accreditation with dual CNAS and ANAB accreditation. Each batch is characterized by orthogonal methods and supplied with a full Certificate of Analysis (COA), ensuring metrological traceability.

Nilotinib Impurity 35 (CAS CATO-C4X-125635) is a certified pharmaceutical impurity reference standard with the molecular formula C28H21F3N8O2 and a molecular weight of 558.51 g/mol.

Structurally, Nilotinib Impurity 35 (C28H21F3N8O2) contains a steroid core, an amide group, a hydroxyl group, an ether linkage, fluorine substitution. The molecule exhibits a degree of unsaturation (DBE) of 21.0, corresponding to approximately 21 ring(s) or double-bond equivalent(s). With a molecular weight of 558.51 g/mol, it falls into the moderately-high-molecular-weight range. Nitrogen-containing functional groups confer excellent ionization efficiency in positive-ion electrospray (ESI) mode, making the compound well suited to LC-MS/MS analysis.

This reference standard supports related-substances testing and method development in line with ICH Q3A/Q3B guidance on impurity control, and is suitable for system suitability testing and forced-degradation studies.

Physical & Chemical Properties

Molecular FormulaC28H21F3N8O2
Molecular Weight558.51 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor, low volatility)
Purity97%+
StorageStore in a cool place (≤25°C), protect from light, keep sealed and dry
Solubility (reference)Soluble in DMSO, DMF, methanol
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening; Contains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)21.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentF-containing
Nitrogen Atoms8

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