Melphalan EP Impurity B CAS 1270153-04-2
| CAS No. | 1270153-04-2 |
| Molecular Formula | C13H18N2O3 |
| Molecular Weight | 250.29 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
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.
Melphalan EP Impurity B (CAS 1270153-04-2) is a certified pharmaceutical impurity reference standard with the molecular formula C13H18N2O3 and a molecular weight of 250.29 g/mol.
Based on its molecular formula C13H18N2O3, Melphalan EP Impurity B contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 250.29 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).
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 | C13H18N2O3 |
| Molecular Weight | 250.29 g/mol |
| Appearance | Off-white to pale yellow crystalline powder |
| Purity | >95% |
| 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) | 6.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1990 |
| Nitrogen Atoms | 2 |
Related Melphalan Standards
- rac-Melphalan EP Impurity B (CAS 1259994-01-8)
- Melphalan EP Impurity C Hydrochloride (CAS 573704-41-3)
- Melphalan EP Impurity A (CAS 72143-20-5)
- Melphalan EP Impurity D (CAS 61733-01-5)
- Melphalan EP Impurity I (CAS 573704-40-2)
- Melphalan Impurity 14 (CAS 1088-80-8)
- Melphalan DL-isomer (CAS 531-76-0)
- Melphalan (CAS 148-82-3)
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