Mirtazapine EP Impurity D CAS 61337-68-6
| CAS No. | 61337-68-6 |
| Molecular Formula | C16H17N3 |
| Molecular Weight | 251.33 g/mol |
| 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 Mirtazapine EP Impurity D.
Mirtazapine EP Impurity D (CAS 61337-68-6) is a certified pharmaceutical impurity reference standard with the molecular formula C16H17N3 and a molecular weight of 251.33 g/mol.
Mirtazapine EP Impurity D (C16H17N3) contains a nitrogen-containing heterocyclic scaffold, a nitrile group. Its high carbon-to-hydrogen ratio confers good lipid solubility; these physicochemical properties determine the optimal preparation and storage of its standard solutions. The presence of an aromatic ring or conjugated system gives the compound characteristic absorption bands in the UV-Vis region, making it well suited to UV or diode-array detection (DAD).
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 | C16H17N3 |
| Molecular Weight | 251.33 g/mol |
| Purity | 97%+ |
| Storage | Store at 2-8°C, protect from light |
| Solubility (reference) | Soluble in DMSO, DMF, methanol |
| Stability | Light-sensitive; avoid direct strong light |
| Degree of Unsaturation (DBE) | 10.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1974 |
| Nitrogen Atoms | 3 |
Related Mirtazapine Standards
- Mirtazapine (CAS 61337-67-5)
- Mirtazapine (CAS 85650-52-8)
- Mirtazapine Impurity 4 (CAS 23174-98-3)
- Mirtazapine EP Impurity E (CAS 191546-94-8)
- Mirtazapine-d3 (CAS 1216678-68-0)
- Mirtazapine Impurity 4 (CAS CATO-C4X-151110)
- Mirtazapine-d4 (CAS 1215898-55-7)
- Mirtazapine Cyano Impurity (Oxalate salt) (CAS 331815-15-7)
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