Osimertinib Impurity 34 CAS 2945220-41-5

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.2945220-41-5
Molecular FormulaC56H66N14O4
Molecular Weight999.21 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Osimertinib Impurity 34 CAS 2945220-41-5 chemical structure

Description

As a certified reference material (CRM), Osimertinib 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.

CATO supplies Osimertinib Impurity 34 (CAS 2945220-41-5), a pharmacopoeial impurity reference standard (molecular formula C56H66N14O4, MW 999.21 g/mol) used for the identification and quantification of trace impurities in APIs.

The molecular framework of Osimertinib Impurity 34 (C56H66N14O4) is characterized by a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage. 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).

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.

Physical & Chemical Properties

Molecular FormulaC56H66N14O4
Molecular Weight999.21 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
Degree of Unsaturation (DBE)31.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)2004
Nitrogen Atoms14

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