Diltiazem Impurity N29 Hydrochloride CAS 42399-54-2

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.42399-54-2
Molecular FormulaC22H26N2O4S
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Diltiazem Impurity N29 Hydrochloride CAS 42399-54-2 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.

As a process- or degradation-related impurity, Diltiazem Impurity N29 Hydrochloride (CAS 42399-54-2, C22H26N2O4SHCl) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Diltiazem Impurity N29 Hydrochloride (C22H26N2O4SHCl) contains a flavonoid core, an amide group, a sulfone group, a hydroxyl group, an ether linkage, chlorine substitution. It is notably hygroscopic, halogen substitution raises its density and boiling point, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. 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).

The assigned purity is verified by mass-balance and quantitative NMR (qNMR) approaches, with the expanded uncertainty reported at a 95% confidence level (k=2). Batch homogeneity and stability are independently assessed for every lot.

Physical & Chemical Properties

Molecular FormulaC22H26N2O4S HCl
Molecular Weight450.98 g/mol
Purity97%+
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.)1969
Halogen ContentCl-containing
Nitrogen Atoms2
Sulfur Atoms1

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