Osimertinib Impurity 45 CAS CATO-C4X-204545

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-204545
Molecular FormulaC23H21N5O3
Molecular Weight415.44 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Osimertinib Impurity 45 CAS CATO-C4X-204545 chemical structure

Description

The occurrence of Osimertinib Impurity 45 is closely related to a steroid core, an amide group, a hydroxyl group, an ether linkage in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

Osimertinib Impurity 45 (CAS CATO-C4X-204545) is a certified pharmaceutical impurity reference standard with the molecular formula C23H21N5O3 and a molecular weight of 415.44 g/mol.

The molecular framework of Osimertinib Impurity 45 (C23H21N5O3) is characterized by a steroid core, 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.

CATO manufactures Osimertinib Impurity 45 under ISO 17034:2016 accreditation with dual CNAS and ANAB accreditation. Each batch is characterized by orthogonal methods and supplied with a full Certificate of Analysis (COA), ensuring metrological traceability.

Physical & Chemical Properties

Molecular FormulaC23H21N5O3
Molecular Weight415.44 g/mol
AppearancePale yellow to yellow crystalline powder
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)16.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Nitrogen Atoms5

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