Promethazine Impurity 53 CAS CATO-C4X-141853

Purity ＞95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-141853
Molecular FormulaC17H20N2
Molecular Weight252.35 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Promethazine Impurity 53 CAS CATO-C4X-141853 chemical structure

Description

As a process- or degradation-related impurity, Promethazine Impurity 53 (CAS CATO-C4X-141853, C17H20N2) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Owing to a nitrogen-containing heterocyclic scaffold, a nitrile group, Promethazine Impurity 53 is typically pale yellow to yellow low-melting solid. Its solid-state physicochemical attributes — including a molecular weight of 252.35 g/mol — guide the selection of appropriate sample preparation and analytical techniques. The presence of an aromatic ring or conjugated system gives the compound characteristic absorption bands in the UV-Vis region, making it well suited to UV or diode-array detection (DAD).

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), Promethazine Impurity 53 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 FormulaC17H20N2
Molecular Weight252.35 g/mol
Purity＞95%
StorageStore at 2-8°C, protect from light
Solubility (reference)Soluble in DMSO, DMF, methanol
StabilityLight-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)9.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Nitrogen Atoms2

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