Neratinib Impurity 15 CAS 1376615-55-2

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.1376615-55-2
Molecular FormulaC30H29ClN6O4
Molecular Weight573.04 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Neratinib Impurity 15 CAS 1376615-55-2 chemical structure

Description

The occurrence of Neratinib Impurity 15 is closely related to a steroid core, an amide group, a hydroxyl group, an ether linkage, chlorine substitution in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

Neratinib Impurity 15 (CAS 1376615-55-2) is a certified pharmaceutical impurity reference standard with the molecular formula C30H29ClN6O4 and a molecular weight of 573.04 g/mol.

Structurally, Neratinib Impurity 15 (C30H29ClN6O4) contains a steroid core, an amide group, a hydroxyl group, an ether linkage, chlorine substitution. The molecule exhibits a degree of unsaturation (DBE) of 19.0, corresponding to approximately 19 ring(s) or double-bond equivalent(s). With a molecular weight of 573.04 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.

CATO manufactures Neratinib Impurity 15 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.

Physical & Chemical Properties

Molecular FormulaC30H29ClN6O4
Molecular Weight573.04 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor)
Purity>95%
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)19.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1991
Halogen ContentCl-containing
Nitrogen Atoms6

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