Erlotinib Impurity 33 CAS 80407-64-3

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.80407-64-3
Molecular FormulaC13H18O5
Molecular Weight254.28 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Erlotinib Impurity 33 CAS 80407-64-3 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.

As a process- or degradation-related impurity, Erlotinib Impurity 33 (CAS 80407-64-3, C13H18O5) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Erlotinib Impurity 33 (C13H18O5) contains a carboxylic acid group, a hydroxyl group, an ether linkage, an aromatic ring system. It is notably hygroscopic, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).

As a certified reference material (CRM), Erlotinib Impurity 33 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 FormulaC13H18O5
Molecular Weight254.28 g/mol
AppearanceOff-white to pale yellow crystalline powder
Purity97%+
StorageStore in a cool place (≤25°C), keep sealed and dry
Solubility (reference)Soluble in methanol, acetonitrile, DMSO, water (slightly soluble)
StabilityMay oxidize slowly on prolonged air exposure; Hygroscopic; reseal immediately after opening
Degree of Unsaturation (DBE)5.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1979

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