Neratinib Impurity N1 CAS 848139-78-6

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.848139-78-6
Molecular FormulaC24H20ClN5O2
Molecular Weight445.90 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Neratinib Impurity N1 CAS 848139-78-6 chemical structure

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Neratinib Impurity N1.

CATO supplies Neratinib Impurity N1 (CAS 848139-78-6), a pharmacopoeial impurity reference standard (molecular formula C24H20ClN5O2, MW 445.90 g/mol) used for the identification and quantification of trace impurities in APIs.

Structurally, Neratinib Impurity N1 (C24H20ClN5O2) contains a steroid core, an amide group, a hydroxyl group, an ether linkage, chlorine substitution. The molecule exhibits a degree of unsaturation (DBE) of 17.0, corresponding to approximately 17 ring(s) or double-bond equivalent(s). With a molecular weight of 445.90 g/mol, it falls into the moderately-high-molecular-weight range. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.

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 N1 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 FormulaC24H20ClN5O2
Molecular Weight445.90 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor)
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)17.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1987
Halogen ContentCl-containing
Nitrogen Atoms5

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