| CAS No. | CATO-C4X-2924199 |
| Molecular Formula | C16H27NO2 |
| Molecular Weight | N/A |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
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.
| Molecular Formula | C16H27NO2 HCl |
| Molecular Weight | 301.86 g/mol |
| Appearance | White to pale yellow crystalline powder. (slight halide-like odor) |
| Purity | ≥95% |
| Storage | Store at 2-8°C, protect from light |
| Solubility (reference) | Soluble in chloroform, dichloromethane, ethyl acetate, DMSO |
| Stability | May 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 Absorption | UV-absorbing |
| Halogen Content | Cl-containing |
| Nitrogen Atoms | 1 |