Labetalol EP Impurity D CAS CATO-C1829030

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C1829030
Molecular FormulaC9H12N2O3
Molecular Weight196.20 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Labetalol EP Impurity D CAS CATO-C1829030 chemical structure

Description

CATO supplies Labetalol EP Impurity D (CAS CATO-C1829030), a pharmacopoeial impurity reference standard (molecular formula C9H12N2O3, MW 196.20 g/mol) used for the identification and quantification of trace impurities in APIs.

Labetalol EP Impurity D (C9H12N2O3) contains an amino-acid-derived structure, an amide group, a hydroxyl group, an ether linkage. It is notably hygroscopic, 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).

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
Molecular Weight196.20 g/mol
AppearanceOff-white to pale yellow crystalline powder. (faint amine-like odor)
Purity97%+
StorageStore at 2-8°C, protect from light, keep sealed and dry
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
Degree of Unsaturation (DBE)5.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Nitrogen Atoms2

Related Labetalol Standards

Recommended Standards

Why CATO?