Osimertinib Impurity 109 CAS CATO-C4X-2045109

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-2045109
Molecular FormulaC56H67N14O4
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Osimertinib Impurity 109 CAS CATO-C4X-2045109 chemical structure

Description

The occurrence of Osimertinib Impurity 109 is closely related to a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, fluorine substitution in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

CATO supplies Osimertinib Impurity 109 (CAS CATO-C4X-2045109), a pharmacopoeial impurity reference standard (molecular formula C56H67N14O4C2HF3O2C2F3O2, MW 1227.28 g/mol) used for the identification and quantification of trace impurities in APIs.

Structurally, Osimertinib Impurity 109 (C56H67N14O4C2HF3O2C2F3O2) contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, fluorine substitution. The molecule exhibits a degree of unsaturation (DBE) of 31.0, corresponding to approximately 31 ring(s) or double-bond equivalent(s). With a molecular weight of 1227.28 g/mol, it falls into the high-molecular-weight range. 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 109 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 FormulaC56H67N14O4 2*C2HF3O2 C2F3O2
Molecular Weight1227.28 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; Contains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)31.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentF-containing
Nitrogen Atoms14

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