Osimertinib Impurity 31 CAS CATO-C4X-204531

Purity 95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-204531
Molecular FormulaC29H35N7O4
Molecular Weight545.63 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Osimertinib Impurity 31 CAS CATO-C4X-204531 chemical structure

Description

The occurrence of Osimertinib Impurity 31 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.

CATO supplies Osimertinib Impurity 31 (CAS CATO-C4X-204531), a pharmacopoeial impurity reference standard (molecular formula C29H35N7O4, MW 545.63 g/mol) used for the identification and quantification of trace impurities in APIs.

Based on its molecular formula C29H35N7O4, Osimertinib Impurity 31 contains a steroid core, an amide group, a hydroxyl group, an ether linkage; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 545.63 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. Nitrogen-containing functional groups confer excellent ionization efficiency in positive-ion electrospray (ESI) mode, making the compound well suited to LC-MS/MS analysis.

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 31 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 FormulaC29H35N7O4
Molecular Weight545.63 g/mol
AppearancePale yellow to yellow crystalline powder
Purity95%
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 Atoms7

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