Rupatadine Impurity 35 dihydrate CAS 1632412-57-7(Anhydrous CAS)

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.1632412-57-7(Anhydrous CAS)
Molecular FormulaC29H30ClN3O2
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Rupatadine Impurity 35 dihydrate CAS 1632412-57-7(Anhydrous CAS) chemical structure

Description

The molecular framework of Rupatadine Impurity 35 dihydrate (C29H30ClN3O2H2O) is characterized by a steroid core, an amide group, a hydroxyl group, an ether linkage, chlorine substitution. In reversed-phase chromatography, its retention is governed primarily by the protonation state of its nitrogen-containing groups, which provides a practical basis for HPLC-UV/DAD or LC-MS method development. Nitrogen-containing functional groups confer excellent ionization efficiency in positive-ion electrospray (ESI) mode, making the compound well suited to LC-MS/MS analysis.

CATO supplies Rupatadine Impurity 35 dihydrate (CAS 1632412-57-7(Anhydrous CAS)), a pharmacopoeial impurity reference standard (molecular formula C29H30ClN3O2H2O, MW 506.04 g/mol) used for the identification and quantification of trace impurities in APIs.

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 manufactures Rupatadine Impurity 35 dihydrate under ISO 17034:2016 accreditation with dual CNAS and ANAB accreditation. Each batch is characterized by orthogonal methods and supplied with a full Certificate of Analysis (COA), ensuring metrological traceability.

Physical & Chemical Properties

Molecular FormulaC29H30ClN3O2 2*H2O
Molecular Weight506.04 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor)
Purity>95%
StorageStore in a cool place (≤25°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; Contains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)15.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentCl-containing
Nitrogen Atoms3

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