Roxatidine Impurity 36 Hydrochloride CAS CATO-C4X-121336

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-121336
Molecular FormulaC18H31N3O
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Roxatidine Impurity 36 Hydrochloride CAS CATO-C4X-121336 chemical structure

Description

CATO supplies Roxatidine Impurity 36 Hydrochloride (CAS CATO-C4X-121336), a pharmacopoeial impurity reference standard (molecular formula C18H31N3OHCl, MW 341.92 g/mol) used for the identification and quantification of trace impurities in APIs.

Based on its molecular formula C18H31N3OHCl, Roxatidine Impurity 36 Hydrochloride contains a steroid core, an amide group, a hydroxyl group, an ether linkage, chlorine substitution; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 341.92 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. 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), Roxatidine Impurity 36 Hydrochloride 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 FormulaC18H31N3O HCl
Molecular Weight341.92 g/mol
AppearanceOff-white to pale yellow crystalline powder. (slight halide-like odor)
Purity>95%
StorageStore at 2-8°C, protect from light
Solubility (reference)Soluble in DMSO, DMF, methanol
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)4.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentCl-containing
Nitrogen Atoms3

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