Trimetazidine EP Impurity B CAS 1257-19-8

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.1257-19-8
Molecular FormulaC24H34N2O6
Molecular Weight446.54 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Trimetazidine EP Impurity B CAS 1257-19-8 chemical structure

Description

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

As a process- or degradation-related impurity, Trimetazidine EP Impurity B (CAS 1257-19-8, C24H34N2O6) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Trimetazidine EP Impurity B (C24H34N2O6) contains a flavonoid core, an amide group, a hydroxyl group, an ether linkage. It is notably hygroscopic, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. 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.

As a certified reference material (CRM), Trimetazidine EP Impurity B 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 FormulaC24H34N2O6
Molecular Weight446.54 g/mol
AppearancePale yellow to yellow crystalline powder
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
Degree of Unsaturation (DBE)9.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1957
Nitrogen Atoms2

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