Glycopyrrolate Impurity 4 CAS CATO-C4X-15174

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-15174
Molecular FormulaC19H26NO3
Molecular Weight316.41 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Glycopyrrolate Impurity 4 CAS CATO-C4X-15174 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 in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

Glycopyrrolate Impurity 4 (CAS CATO-C4X-15174) is a certified pharmaceutical impurity reference standard with the molecular formula C19H26NO3 and a molecular weight of 316.41 g/mol.

The molecular framework of Glycopyrrolate Impurity 4 (C19H26NO3) is characterized by a steroid core, an amide group, a hydroxyl group, an ether linkage. 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 aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).

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 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 FormulaC19H26NO3
Molecular Weight316.41 g/mol
AppearanceOff-white to pale yellow crystalline powder
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
Degree of Unsaturation (DBE)7.5
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Nitrogen Atoms1

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