Glycopyrrolate Impurity 7 CAS CATO-C4X-18177

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-18177
Molecular FormulaC24H36NO3
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Glycopyrrolate Impurity 7 CAS CATO-C4X-18177 chemical structure

Description

CATO supplies Glycopyrrolate Impurity 7 (CAS CATO-C4X-18177), a pharmacopoeial impurity reference standard (molecular formula C24H36NO3Br, MW 466.46 g/mol) used for the identification and quantification of trace impurities in APIs.

Based on its molecular formula C24H36NO3Br, Glycopyrrolate Impurity 7 contains a steroid core, an amide group, a hydroxyl group, an ether linkage, bromine substitution; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 466.46 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. 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 FormulaC24H36NO3 Br
Molecular Weight466.46 g/mol
AppearanceOff-white to pale yellow crystalline powder. (slight halide-like odor)
Purity97%+
StorageStore at room temperature, protect from light, keep sealed and dry
Solubility (reference)Soluble in chloroform, dichloromethane, ethyl acetate, DMSO
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)7.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentBr-containing
Nitrogen Atoms1

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