Erlotinib Impurity 107 CAS 299912-59-7

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.299912-59-7
Molecular FormulaC25H29N3O5
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Erlotinib Impurity 107 CAS 299912-59-7 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 107.

CATO supplies Erlotinib Impurity 107 (CAS 299912-59-7), a pharmacopoeial impurity reference standard (molecular formula C25H29N3O5HCl, MW 487.98 g/mol) used for the identification and quantification of trace impurities in APIs.

Owing to a flavonoid core, an amide group, a hydroxyl group, an ether linkage, chlorine substitution, Erlotinib Impurity 107 is typically pale yellow to yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 487.98 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.

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.

As a certified reference material (CRM), Erlotinib Impurity 107 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 FormulaC25H29N3O5 HCl
Molecular Weight487.98 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)12.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)2025
Halogen ContentCl-containing
Nitrogen Atoms3

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