Mirogabalin Impurity 170 CAS CATO-C4X-2924170
| CAS No. | CATO-C4X-2924170 |
| Molecular Formula | C12H19NO2 |
| Molecular Weight | N/A |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
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 170.
CATO supplies Mirogabalin Impurity 170 (CAS CATO-C4X-2924170), a pharmacopoeial impurity reference standard (molecular formula C12H19NO2HCl, MW 245.75 g/mol) used for the identification and quantification of trace impurities in APIs.
Mirogabalin Impurity 170 (C12H19NO2HCl) contains an amide group, a carboxylic acid group, a hydroxyl group, an ether linkage, chlorine substitution. Halogen substitution raises its density and boiling point, 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. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.
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 Formula | C12H19NO2 HCl |
| Molecular Weight | 245.75 g/mol |
| Appearance | White to pale yellow crystalline powder. (slight halide-like odor) |
| Purity | 97%+ |
| Storage | Store at 2-8°C, protect from light, keep tightly closed to prevent evaporation |
| 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 |
Related Mirogabalin Standards
- Mirogabalin (CAS 1138245-13-2)
- Mirogabalin Impurity N85 (CAS 1138245-15-4)
- Mirogabalin Impurity 61 Formate Salt (CAS 1138245-15-4 (free base))
- Mirogabalin Impurity (CAS 1138245-20-1)
- Mirogabalin besylate (CAS 1138245-21-2)
- Mirogabalin Impurity 16 (CAS 1138245-48-3)
- Mirogabalin Impurity 18 (CAS 1138245-49-4)
- Mirogabalin Impurity 42 (CAS 1138245-50-7)
Recommended Standards
- Oxytetracycline EP Impurity E (CAS 18751-99-0)
- Netilmicin EP Impurity B (CAS 67666-41-5)
- Mirogabalin Impurity 32 (CAS CATO-C4X-292432)
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Why CATO?
- ISO 17034 accredited reference material producer (CNAS + ANAB dual accreditation)
- 130,000+ catalog items in stock, COA supplied with every batch
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- Technical support: +86 18665070610 / Nicole.chen@cato-chem.com