Labetalol EP Impurity D HCl CAS 32780-65-7

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.32780-65-7
Molecular FormulaC9H12N2O3
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Labetalol EP Impurity D HCl CAS 32780-65-7 chemical structure

Description

The occurrence of Labetalol EP Impurity D HCl is closely related to a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, chlorine substitution in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

CATO supplies Labetalol EP Impurity D HCl (CAS 32780-65-7), a pharmacopoeial impurity reference standard (molecular formula C9H12N2O3HCl, MW 232.66 g/mol) used for the identification and quantification of trace impurities in APIs.

Based on its molecular formula C9H12N2O3HCl, Labetalol EP Impurity D HCl contains a nitrogen-containing heterocyclic scaffold, 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 232.66 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.

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 FormulaC9H12N2O3 HCl
Molecular Weight232.66 g/mol
AppearanceOff-white to pale yellow crystalline powder. (slight halide-like odor, faint amine-like odor)
Purity>95%
StorageStore at 2-8°C, protect from light, keep sealed and dry, keep tightly closed to prevent evaporation
Solubility (reference)Soluble in methanol, ethanol, DMSO
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)4.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1966
Halogen ContentCl-containing
Nitrogen Atoms2

Related Labetalol Standards

Recommended Standards

Why CATO?