Ramelteon Impurity 62 CAS 809097-20-8

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.809097-20-8
Molecular FormulaC16H21NO3
Molecular Weight275.34 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Ramelteon Impurity 62 CAS 809097-20-8 chemical structure

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Ramelteon Impurity 62.

As a process- or degradation-related impurity, Ramelteon Impurity 62 (CAS 809097-20-8, C16H21NO3) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Ramelteon Impurity 62 (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).

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.

The assigned purity is verified by mass-balance and quantitative NMR (qNMR) approaches, with the expanded uncertainty reported at a 95% confidence level (k=2). Batch homogeneity and stability are independently assessed for every lot.

Physical & Chemical Properties

Molecular FormulaC16H21NO3
Molecular Weight275.34 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)7.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1986
Nitrogen Atoms1

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