Labetalol Impurity 65 CAS CATO-C4X-246665

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-246665
Molecular FormulaC11H15NO4
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Labetalol Impurity 65 CAS CATO-C4X-246665 chemical structure

Description

CATO supplies Labetalol Impurity 65 (CAS CATO-C4X-246665), a pharmacopoeial impurity reference standard (molecular formula C11H15NO4HCl, MW 261.70 g/mol) used for the identification and quantification of trace impurities in APIs.

The molecular framework of Labetalol Impurity 65 (C11H15NO4HCl) is characterized by a nitrogen-containing heterocyclic scaffold, an amide 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. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.

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), Labetalol Impurity 65 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 FormulaC11H15NO4 HCl
Molecular Weight261.70 g/mol
AppearanceOff-white to pale yellow crystalline powder. (slight halide-like odor)
Purity97%+
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
Halogen ContentCl-containing
Nitrogen Atoms1

Related Labetalol Standards

Recommended Standards

Why CATO?