Mirogabalin Impurity 151 CAS CATO-C4X-2924151

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 151.

As a process- or degradation-related impurity, Mirogabalin Impurity 151 (CAS CATO-C4X-2924151, C11H17NO2) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Mirogabalin Impurity 151 (C11H17NO2) contains an amino-acid-derived structure, 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 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

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