Erlotinib Impurity 146 CAS CATO-C4X-1069146

Purity ≥95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-1069146
Molecular FormulaC21H20ClN3O3
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Erlotinib Impurity 146 CAS CATO-C4X-1069146 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 Erlotinib Impurity 146.

CATO supplies Erlotinib Impurity 146 (CAS CATO-C4X-1069146), a pharmacopoeial impurity reference standard (molecular formula C21H20ClN3O3HCl, MW 434.32 g/mol) used for the identification and quantification of trace impurities in APIs.

Owing to a steroid core, an amide group, a hydroxyl group, an ether linkage, chlorine substitution, Erlotinib Impurity 146 is typically pale yellow to yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 434.32 g/mol — guide the selection of appropriate sample preparation and analytical techniques. The presence of an aromatic ring or conjugated system gives the compound characteristic absorption bands in the UV-Vis region, making it well suited to UV or diode-array detection (DAD).

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.

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 FormulaC21H20ClN3O3 HCl
Molecular Weight434.32 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor, low volatility)
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)12.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentCl-containing
Nitrogen Atoms3

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