Doxylamine Hydrogen Succinate EP Impurity A CAS CATO-C4X-178921

Purity ≥95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-178921
Molecular FormulaC17H22N2O
Molecular Weight270.37 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Doxylamine Hydrogen Succinate EP Impurity A CAS CATO-C4X-178921 chemical structure

Description

As a certified reference material (CRM), Doxylamine Hydrogen Succinate EP Impurity A 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.

As a process- or degradation-related impurity, Doxylamine Hydrogen Succinate EP Impurity A (CAS CATO-C4X-178921, C17H22N2O) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Owing to a steroid core, an amide group, a hydroxyl group, an ether linkage, Doxylamine Hydrogen Succinate EP Impurity A is typically pale yellow to yellow low-melting solid. Its solid-state physicochemical attributes — including a molecular weight of 270.37 g/mol — guide the selection of appropriate sample preparation and analytical techniques. The high carbon-to-hydrogen ratio imparts good lipophilicity, allowing liquid-liquid extraction with non-polar solvents such as n-hexane or ethyl acetate.

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.

Physical & Chemical Properties

Molecular FormulaC17H22N2O
Molecular Weight270.37 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)8.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Nitrogen Atoms2

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