Mirogabalin Impurity 95 CAS CATO-C4X-292495

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-292495
Molecular FormulaC12H16O4
Molecular Weight224.25 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Mirogabalin Impurity 95 CAS CATO-C4X-292495 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 Mirogabalin Impurity 95.

As a process- or degradation-related impurity, Mirogabalin Impurity 95 (CAS CATO-C4X-292495, C12H16O4) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Mirogabalin Impurity 95 (C12H16O4) contains a carboxylic acid group, a hydroxyl group, an ether linkage, an aromatic ring system. 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).

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 FormulaC12H16O4
Molecular Weight224.25 g/mol
AppearanceOff-white to pale yellow crystalline powder
Purity97%+
StorageStore in a cool place (≤25°C), keep sealed and dry
Solubility (reference)Soluble in chloroform, dichloromethane, ethyl acetate, DMSO
StabilityMay oxidize slowly on prolonged air exposure; Hygroscopic; reseal immediately after opening
Degree of Unsaturation (DBE)5.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present

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