Mianserin Impurity 60 CAS 21535-46-6
| CAS No. | 21535-46-6 |
| Molecular Formula | C18H16N2O2 |
| Molecular Weight | 292.33 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
As a process- or degradation-related impurity, Mianserin Impurity 60 (CAS 21535-46-6, C18H16N2O2) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
The molecular framework of Mianserin Impurity 60 (C18H16N2O2) is characterized by a steroid core, an amide group, a hydroxyl group, an ether linkage. In reversed-phase chromatography, its retention is governed primarily by its high hydrophobicity (logP), which provides a practical basis for HPLC-UV/DAD or LC-MS method development. 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.
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 | C18H16N2O2 |
| Molecular Weight | 292.33 g/mol |
| Appearance | Pale yellow to yellow crystalline powder |
| Purity | 97%+ |
| Storage | Store at 2-8°C, protect from light, keep sealed and dry |
| Solubility (reference) | Soluble in DMSO, DMF, methanol |
| Stability | May oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening |
| Degree of Unsaturation (DBE) | 12.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1963 |
| Nitrogen Atoms | 2 |
Related Mianserin Standards
- Mianserin Impurity 112 (CAS 77117-76-1)
- Mianserin impurity 55 (CAS CATO-C4X-136955)
- Mianserin Impurity 100 (CAS CATO-C4X-1369100)
- Mianserin Impurity 88 (CAS CATO-C4X-136988)
- Mianserin Impurity 90 (CAS CATO-C4X-136990)
- Mianserin Impurity 106 (CAS CATO-C4X-1369106)
- Mianserin Impurity 123 (CAS CATO-C4X-1369123)
- Mianserin impurity 40 (CAS CATO-C4X-136940)
Recommended Standards
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