Melphalan EP Impurity I HCl CAS CATO-C4X-19889
| CAS No. | CATO-C4X-19889 |
| Molecular Formula | C14H21ClN2O3 |
| Molecular Weight | N/A |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
Melphalan EP Impurity I HCl (CAS CATO-C4X-19889) is a certified pharmaceutical impurity reference standard with the molecular formula C14H21ClN2O3HCl and a molecular weight of 337.24 g/mol.
Owing to a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, chlorine substitution, Melphalan EP Impurity I HCl is typically off-white to pale yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 337.24 g/mol — guide the selection of appropriate sample preparation and analytical techniques. 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.
As a certified reference material (CRM), Melphalan EP Impurity I HCl meets the metrological traceability requirements of ISO/IEC 17025 laboratories. Batch-to-batch consistency is monitored via control charts to guarantee comparable assigned values across lots.
Physical & Chemical Properties
| Molecular Formula | C14H21ClN2O3 HCl |
| Molecular Weight | 337.24 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) | 4.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| Halogen Content | Cl-containing |
| Nitrogen Atoms | 2 |
Related Melphalan Standards
- Melphalan Isopropyl Ester (CAS 104874-57-9)
- Melphalan Impurity 14 (CAS 1088-80-8)
- Melphalan EP Impurity K (CAS 109-89-7)
- Melphalan-d (CAS 1217854-43-7)
- rac-Melphalan EP Impurity B (CAS 1259994-01-8)
- Melphalan EP Impurity B (CAS 1270153-04-2)
- D-Melphalan (CAS 13045-94-8)
- Melphalan Racemic Mixture (CAS 1465-26-5)
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- 3-Methoxy-4-methyl-1H-pyrrole (CAS 29206-35-7)
- 2-[1-(3-Chloro-2-cyanophenyl)-1H-pyrrol-2-yl]-N,N-diethyl-2-oxoacetamide (CAS 866010-47-1)
- 2-Allyl-1,3,2-dioxaborolane (CAS 74348-96-2)
- Biotinyl-Neuropeptide W-23 (human) (CAS 1815618-09-7)
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