Abemaciclib Impurity 15 Formate CAS CATO-C4X-293715

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-293715
Molecular FormulaC42H44F4N12
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Abemaciclib Impurity 15 Formate CAS CATO-C4X-293715 chemical structure

Description

The occurrence of Abemaciclib Impurity 15 Formate 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.

Abemaciclib Impurity 15 Formate (CAS CATO-C4X-293715) is a certified pharmaceutical impurity reference standard with the molecular formula C42H44F4N12CH2O2 and a molecular weight of 838.91 g/mol.

The molecular framework of Abemaciclib Impurity 15 Formate (C42H44F4N12CH2O2) is characterized by a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, fluorine substitution. 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. 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.

As a certified reference material (CRM), Abemaciclib Impurity 15 Formate 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 FormulaC42H44F4N12 CH2O2
Molecular Weight838.91 g/mol
Purity>95%
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)25.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentF-containing
Nitrogen Atoms12

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