Mirogabalin Impurity 128 CAS CATO-C4X-2924128

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-2924128
Molecular FormulaC11H18O2
Molecular Weight182.26 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Mirogabalin Impurity 128 CAS CATO-C4X-2924128 chemical structure

Description

Based on its molecular formula C11H18O2, Mirogabalin Impurity 128 contains a carboxylic acid group, a hydroxyl group, an ether linkage; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 182.26 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. The high carbon-to-hydrogen ratio imparts good lipophilicity, allowing liquid-liquid extraction with non-polar solvents such as n-hexane or ethyl acetate.

As a process- or degradation-related impurity, Mirogabalin Impurity 128 (CAS CATO-C4X-2924128, C11H18O2) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

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.

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 FormulaC11H18O2
Molecular Weight182.26 g/mol
Purity97%+
StorageStore at 2-8°C
Solubility (reference)Soluble in chloroform, dichloromethane, ethyl acetate, DMSO
StabilityMay oxidize slowly on prolonged air exposure
Degree of Unsaturation (DBE)3.0
UV AbsorptionUV-absorbing

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