Mirogabalin Impurity 199 CAS CATO-C4X-2924199

Purity ≥95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-2924199
Molecular FormulaC16H27NO2
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Mirogabalin Impurity 199 CAS CATO-C4X-2924199 chemical structure

Description

As a certified reference material (CRM), Mirogabalin Impurity 199 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.

CATO supplies Mirogabalin Impurity 199 (CAS CATO-C4X-2924199), a pharmacopoeial impurity reference standard (molecular formula C16H27NO2HCl, MW 301.86 g/mol) used for the identification and quantification of trace impurities in APIs.

Based on its molecular formula C16H27NO2HCl, Mirogabalin Impurity 199 contains an amide group, a carboxylic acid group, a hydroxyl group, an ether linkage, chlorine substitution; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 301.86 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.

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 FormulaC16H27NO2 HCl
Molecular Weight301.86 g/mol
AppearanceWhite to pale yellow crystalline powder. (slight halide-like odor)
Purity≥95%
StorageStore at 2-8°C, protect from light
Solubility (reference)Soluble in chloroform, dichloromethane, ethyl acetate, DMSO
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Contains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)3.0
UV AbsorptionUV-absorbing
Halogen ContentCl-containing
Nitrogen Atoms1

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