Glycopyrrolate Impurity 4 CAS 475468-09-8

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.475468-09-8
Molecular FormulaC19H28NO3
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Glycopyrrolate Impurity 4 CAS 475468-09-8 chemical structure

Description

The occurrence of Glycopyrrolate Impurity 4 is closely related to a steroid core, an amide group, a hydroxyl group, an ether linkage, bromine substitution in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

CATO supplies Glycopyrrolate Impurity 4 (CAS 475468-09-8), a pharmacopoeial impurity reference standard (molecular formula C19H28NO3Br, MW 398.34 g/mol) used for the identification and quantification of trace impurities in APIs.

The molecular framework of Glycopyrrolate Impurity 4 (C19H28NO3Br) is characterized by a steroid core, an amide group, a hydroxyl group, an ether linkage, bromine substitution. In reversed-phase chromatography, its retention is governed primarily by its high hydrophobicity (logP), which provides a practical basis for HPLC-UV/DAD or LC-MS method development. The high carbon-to-hydrogen ratio imparts good lipophilicity, allowing liquid-liquid extraction with non-polar solvents such as n-hexane or ethyl acetate.

Recommended for quantitative analysis by HPLC, GC, LC-MS/MS, or GC-MS as an external calibration standard; it can also be used for spiked-recovery experiments, LOD/LOQ determination, and LC-MS/MS multiple-reaction-monitoring (MRM) calibration.

CATO manufactures Glycopyrrolate Impurity 4 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 FormulaC19H28NO3 Br
Molecular Weight398.34 g/mol
AppearanceOff-white to pale yellow crystalline powder. (slight halide-like odor)
Purity>95%
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)6.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)2025
Halogen ContentBr-containing
Nitrogen Atoms1

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