Mirogabalin Impurity 103 CAS CATO-C4X-2924103

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-2924103
Molecular FormulaC12H17NO3
Molecular Weight223.27 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Mirogabalin Impurity 103 CAS CATO-C4X-2924103 chemical structure

Description

As a certified reference material (CRM), Mirogabalin Impurity 103 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.

As a process- or degradation-related impurity, Mirogabalin Impurity 103 (CAS CATO-C4X-2924103, C12H17NO3) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Mirogabalin Impurity 103 (C12H17NO3) contains an amino-acid-derived structure, an amide group, a hydroxyl group, an ether linkage. It is notably hygroscopic, 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 presence of an aromatic ring or conjugated system gives the compound characteristic absorption bands in the UV-Vis region, making it well suited to UV or diode-array detection (DAD).

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.

Physical & Chemical Properties

Molecular FormulaC12H17NO3
Molecular Weight223.27 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; Hygroscopic; reseal immediately after opening
Degree of Unsaturation (DBE)5.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Nitrogen Atoms1

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