Glycopyrrolate Impurity 2 CAS CATO-C4X-15172

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-15172
Molecular FormulaC18H24ClNO3
Molecular Weight337.84 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Glycopyrrolate Impurity 2 CAS CATO-C4X-15172 chemical structure

Description

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.

CATO supplies Glycopyrrolate Impurity 2 (CAS CATO-C4X-15172), a pharmacopoeial impurity reference standard (molecular formula C18H24ClNO3, MW 337.84 g/mol) used for the identification and quantification of trace impurities in APIs.

Based on its molecular formula C18H24ClNO3, Glycopyrrolate Impurity 2 contains a steroid core, an amide group, a hydroxyl group, an ether linkage, chlorine substitution; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 337.84 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).

CATO manufactures Glycopyrrolate Impurity 2 under ISO 17034:2016 accreditation with dual CNAS and ANAB accreditation. Each batch is characterized by orthogonal methods and supplied with a full Certificate of Analysis (COA), ensuring metrological traceability.

Physical & Chemical Properties

Molecular FormulaC18H24ClNO3
Molecular Weight337.84 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
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 ContentCl-containing
Nitrogen Atoms1

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