Mirogabalin Impurity N86 HCl CAS CATO-CP155186
| CAS No. | CATO-CP155186 |
| Molecular Formula | C12H19NO3 |
| Molecular Weight | N/A |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
The occurrence of Mirogabalin Impurity N86 HCl is closely related to an amide group, a carboxylic acid group, a hydroxyl group, an ether linkage, chlorine substitution in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.
CATO supplies Mirogabalin Impurity N86 HCl (CAS CATO-CP155186), a pharmacopoeial impurity reference standard (molecular formula C12H19NO3HCl, MW 261.75 g/mol) used for the identification and quantification of trace impurities in APIs.
Structurally, Mirogabalin Impurity N86 HCl (C12H19NO3HCl) contains an amide group, a carboxylic acid group, a hydroxyl group, an ether linkage, chlorine substitution. The molecule exhibits a degree of unsaturation (DBE) of 3.0, corresponding to approximately 3 ring(s) or double-bond equivalent(s). With a molecular weight of 261.75 g/mol, it falls into the medium-molecular-weight range. 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 | C12H19NO3 HCl |
| Molecular Weight | 261.75 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 sealed and dry, 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; Hygroscopic; reseal immediately after opening; 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)
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- 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)
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