Ramelteon Impurity 19 CAS CATO-C4X-262219

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-262219
Molecular FormulaC26H33NO2
Molecular Weight391.55 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Ramelteon Impurity 19 CAS CATO-C4X-262219 chemical structure

Description

CATO supplies Ramelteon Impurity 19 (CAS CATO-C4X-262219), a pharmacopoeial impurity reference standard (molecular formula C26H33NO2, MW 391.55 g/mol) used for the identification and quantification of trace impurities in APIs.

The molecular framework of Ramelteon Impurity 19 (C26H33NO2) 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.

As a certified reference material (CRM), Ramelteon Impurity 19 meets the metrological traceability requirements of ISO/IEC 17025 laboratories. Batch-to-batch consistency is monitored via control charts to guarantee comparable assigned values across lots.

Physical & Chemical Properties

Molecular FormulaC26H33NO2
Molecular Weight391.55 g/mol
AppearancePale yellow to yellow crystalline powder
Purity>95%
StorageStore at 2-8°C, protect from light
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)11.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Nitrogen Atoms1

Related Ramelteon Standards

Recommended Standards

Why CATO?