Erlotinib Impurity 34 CAS 183322-17-0

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.183322-17-0
Molecular FormulaC15H23NO6
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Erlotinib Impurity 34 CAS 183322-17-0 chemical structure

Description

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 supplies Erlotinib Impurity 34 (CAS 183322-17-0), a pharmacopoeial impurity reference standard (molecular formula C15H23NO6HCl, MW 349.81 g/mol) used for the identification and quantification of trace impurities in APIs.

The molecular framework of Erlotinib Impurity 34 (C15H23NO6HCl) is characterized by a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, chlorine substitution. In reversed-phase chromatography, its retention is governed primarily by the protonation state of its nitrogen-containing groups, which provides a practical basis for HPLC-UV/DAD or LC-MS method development. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).

As a certified reference material (CRM), Erlotinib Impurity 34 meets the metrological traceability requirements of ISO/IEC 17025 laboratories. Batch-to-batch consistency is monitored via control charts to guarantee comparable assigned values across lots.

Physical & Chemical Properties

Molecular FormulaC15H23NO6 HCl
Molecular Weight349.81 g/mol
AppearanceOff-white to pale yellow crystalline powder. (slight halide-like odor)
Purity>95%
StorageStore at 2-8°C, protect from light, keep sealed and dry
Solubility (reference)Soluble in methanol, acetonitrile, DMSO, water (slightly soluble)
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Contains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)4.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)2009
Halogen ContentCl-containing
Nitrogen Atoms1

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