Carvedilol Impurity 16 CAS 64464-07-9

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.64464-07-9
Molecular FormulaC9H13NO2
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Carvedilol Impurity 16 CAS 64464-07-9 chemical structure

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Carvedilol Impurity 16.

Carvedilol Impurity 16 (CAS 64464-07-9) is a certified pharmaceutical impurity reference standard with the molecular formula C9H13NO2HCl and a molecular weight of 203.67 g/mol.

Owing to an amide group, a carboxylic acid group, a hydroxyl group, an ether linkage, chlorine substitution, Carvedilol Impurity 16 is typically white to pale yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 203.67 g/mol — guide the selection of appropriate sample preparation and analytical techniques. Nitrogen-containing functional groups confer excellent ionization efficiency in positive-ion electrospray (ESI) mode, making the compound well suited to LC-MS/MS analysis.

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 FormulaC9H13NO2 HCl
Molecular Weight203.67 g/mol
AppearanceWhite to pale yellow crystalline powder. (slight halide-like odor, faint amine-like odor)
Purity>95%
StorageStore at 2-8°C, protect from light, keep tightly closed to prevent evaporation
Solubility (reference)Soluble in methanol, acetonitrile, DMSO, water (slightly soluble)
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Contains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)3.0
UV AbsorptionUV-absorbing
CAS Registry Year (est.)1975
Halogen ContentCl-containing
Nitrogen Atoms1

Related Carvedilol Standards

Recommended Standards

Why CATO?