Nebivolol Impurity 63 CAS CATO-C4X-196863

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-196863
Molecular FormulaC11H11FO3
Molecular Weight210.20 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Nebivolol Impurity 63 CAS CATO-C4X-196863 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 Nebivolol Impurity 63.

As a process- or degradation-related impurity, Nebivolol Impurity 63 (CAS CATO-C4X-196863, C11H11FO3) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Owing to a carboxylic acid group, a hydroxyl group, an ether linkage, fluorine substitution, an aromatic ring system, Nebivolol Impurity 63 is typically off-white to pale yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 210.20 g/mol — guide the selection of appropriate sample preparation and analytical techniques. 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), Nebivolol Impurity 63 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 FormulaC11H11FO3
Molecular Weight210.20 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)6.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentF-containing

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