Rupatadine impurity 8 CAS CATO-C4X-10278

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-10278
Molecular FormulaC26H26ClN3O
Molecular Weight431.96 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Rupatadine impurity 8 CAS CATO-C4X-10278 chemical structure

Description

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.

CATO supplies Rupatadine impurity 8 (CAS CATO-C4X-10278), a pharmacopoeial impurity reference standard (molecular formula C26H26ClN3O, MW 431.96 g/mol) used for the identification and quantification of trace impurities in APIs.

Based on its molecular formula C26H26ClN3O, Rupatadine impurity 8 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 431.96 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. Nitrogen-containing functional groups confer excellent ionization efficiency in positive-ion electrospray (ESI) mode, making the compound well suited to LC-MS/MS analysis.

As a certified reference material (CRM), Rupatadine impurity 8 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 FormulaC26H26ClN3O
Molecular Weight431.96 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor)
Purity>95%
StorageStore at room temperature, 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)15.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentCl-containing
Nitrogen Atoms3

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