Methylaminolevulinate EP Impurity B HCl CAS 5451-09-2
| CAS No. | 5451-09-2 |
| Molecular Formula | C5H9NO3 |
| Molecular Weight | N/A |
| 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.
As a process- or degradation-related impurity, Methylaminolevulinate EP Impurity B HCl (CAS 5451-09-2, C5H9NO3HCl) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Structurally, Methylaminolevulinate EP Impurity B HCl (C5H9NO3HCl) contains an amide group, a carboxylic acid group, a hydroxyl group, an ether linkage, chlorine substitution. The molecule exhibits a degree of unsaturation (DBE) of 1.0, corresponding to approximately 1 ring(s) or double-bond equivalent(s). With a molecular weight of 167.59 g/mol, it falls into the medium-molecular-weight range. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.
As a certified reference material (CRM), Methylaminolevulinate EP Impurity B 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 | C5H9NO3 HCl |
| Molecular Weight | 167.59 g/mol |
| Purity | >95% |
| Storage | Store at 2-8°C, protect from light, keep sealed and dry, keep tightly closed to prevent evaporation |
| Solubility (reference) | Soluble in methanol, ethanol, DMSO, water |
| Stability | Light-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening; Contains ester bond; hydrolyzes under strong alkaline conditions |
| Degree of Unsaturation (DBE) | 1.0 |
| CAS Registry Year (est.) | 1958 |
| Halogen Content | Cl-containing |
| Nitrogen Atoms | 1 |
Related Methylaminolevulinate Standards
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