Melphalan EP Impurity H CAS 88457-23-2
| CAS No. | 88457-23-2 |
| Molecular Formula | C14H20Cl2N2O2 |
| Molecular Weight | 319.23 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
Compared with other compounds in its class, the molecular weight of 319.23 g/mol gives Melphalan EP Impurity H distinctive chromatographic separation conditions and mass-spectrometry parameter settings.
As a process- or degradation-related impurity, Melphalan EP Impurity H (CAS 88457-23-2, C14H20Cl2N2O2) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Owing to a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, chlorine substitution, Melphalan EP Impurity H is typically off-white to pale yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 319.23 g/mol — guide the selection of appropriate sample preparation and analytical techniques. 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 | C14H20Cl2N2O2 |
| Molecular Weight | 319.23 g/mol |
| Appearance | Off-white to pale yellow crystalline powder. (slight halide-like odor, low volatility) |
| 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; Contains ester bond; hydrolyzes under strong alkaline conditions |
| Degree of Unsaturation (DBE) | 5.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1982 |
| Halogen Content | Cl-containing |
| Nitrogen Atoms | 2 |
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