Trimetazidine Impurity 13 CAS 92700-82-8

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.92700-82-8
Molecular FormulaC15H22N2O4
Molecular Weight294.35 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Trimetazidine Impurity 13 CAS 92700-82-8 chemical structure

Description

As a process- or degradation-related impurity, Trimetazidine Impurity 13 (CAS 92700-82-8, C15H22N2O4) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Owing to a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, Trimetazidine Impurity 13 is typically off-white to pale yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 294.35 g/mol — guide the selection of appropriate sample preparation and analytical techniques. 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.

The assigned purity is verified by mass-balance and quantitative NMR (qNMR) approaches, with the expanded uncertainty reported at a 95% confidence level (k=2). Batch homogeneity and stability are independently assessed for every lot.

Physical & Chemical Properties

Molecular FormulaC15H22N2O4
Molecular Weight294.35 g/mol
AppearanceOff-white to pale yellow crystalline powder
Purity>95%
StorageStore at 2-8°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)6.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1983
Nitrogen Atoms2

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