Ramelteon Impurity 31 CAS 1204581-50-9

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.1204581-50-9
Molecular FormulaC16H21NO3
Molecular Weight275.34 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Ramelteon Impurity 31 CAS 1204581-50-9 chemical structure

Description

Ramelteon Impurity 31 (C16H21NO3) contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage. Its high carbon-to-hydrogen ratio confers good lipid solubility, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).

Ramelteon Impurity 31 (CAS 1204581-50-9) is a certified pharmaceutical impurity reference standard with the molecular formula C16H21NO3 and a molecular weight of 275.34 g/mol.

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 31 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 FormulaC16H21NO3
Molecular Weight275.34 g/mol
AppearanceOff-white to pale yellow crystalline powder
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
Degree of Unsaturation (DBE)7.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1990
Nitrogen Atoms1

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