Diltiazem EP Impurity A HCl CAS 103532-27-0

Purity >90%In StockPharmacopoeial Impurity Standards
CAS No.103532-27-0
Molecular FormulaC22H26N2O4S
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Diltiazem EP Impurity A HCl CAS 103532-27-0 chemical structure

Description

The molecular framework of Diltiazem EP Impurity A HCl (C22H26N2O4SHCl) is characterized by a flavonoid core, an amide group, a sulfone 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.

Diltiazem EP Impurity A HCl (CAS 103532-27-0) is a certified pharmaceutical impurity reference standard with the molecular formula C22H26N2O4SHCl and a molecular weight of 450.98 g/mol.

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), Diltiazem EP Impurity A HCl 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 FormulaC22H26N2O4S HCl
Molecular Weight450.98 g/mol
Purity>90%
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)10.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1986
Halogen ContentCl-containing
Nitrogen Atoms2
Sulfur Atoms1

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