Neratinib Impurity 1 CAS CATO-C4X-11341

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-11341
Molecular FormulaC50H38Cl2N10O6
Molecular Weight945.81 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Neratinib Impurity 1 CAS CATO-C4X-11341 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 1.

CATO supplies Neratinib Impurity 1 (CAS CATO-C4X-11341), a pharmacopoeial impurity reference standard (molecular formula C50H38Cl2N10O6, MW 945.81 g/mol) used for the identification and quantification of trace impurities in APIs.

Owing to a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, chlorine substitution, Neratinib Impurity 1 is typically pale yellow to yellow amorphous powder. Its solid-state physicochemical attributes — including a molecular weight of 945.81 g/mol — guide the selection of appropriate sample preparation and analytical techniques. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.

Recommended for quantitative analysis by HPLC, GC, LC-MS/MS, or GC-MS as an external calibration standard; it can also be used for spiked-recovery experiments, LOD/LOQ determination, and LC-MS/MS multiple-reaction-monitoring (MRM) calibration.

The assigned purity is verified by mass-balance and quantitative NMR (qNMR) approaches, with the expanded uncertainty reported at a 95% confidence level (k=2). Batch homogeneity and stability are independently assessed for every lot.

Physical & Chemical Properties

Molecular FormulaC50H38Cl2N10O6
Molecular Weight945.81 g/mol
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)36.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentCl-containing
Nitrogen Atoms10

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