Labetalol Impurity 77 CAS CATO-C4X-246677

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-246677
Molecular FormulaC19H21BrN2O3
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Labetalol Impurity 77 CAS CATO-C4X-246677 chemical structure

Description

Structurally, Labetalol Impurity 77 (C19H21BrN2O3HCl) contains a steroid core, an amide group, a hydroxyl group, an ether linkage, chlorine/bromine substitution. The molecule exhibits a degree of unsaturation (DBE) of 9.0, corresponding to approximately 9 ring(s) or double-bond equivalent(s). With a molecular weight of 441.75 g/mol, it falls into the moderately-high-molecular-weight range. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.

CATO supplies Labetalol Impurity 77 (CAS CATO-C4X-246677), a pharmacopoeial impurity reference standard (molecular formula C19H21BrN2O3HCl, MW 441.75 g/mol) used for the identification and quantification of trace impurities in APIs.

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 FormulaC19H21BrN2O3 HCl
Molecular Weight441.75 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor, low volatility)
Purity97%+
StorageStore in a cool place (≤25°C), protect from light, keep sealed and dry
Solubility (reference)Soluble in DMSO, DMF, methanol
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)9.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentCl/Br-containing
Nitrogen Atoms2

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