Methyldopa EP Impurity B HCl CAS 35026-10-9
| CAS No. | 35026-10-9 |
| Molecular Formula | C11H15NO3 |
| Molecular Weight | N/A |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
Compared with other compounds in its class, the molecular weight of 245.70 g/mol gives Methyldopa EP Impurity B HCl distinctive chromatographic separation conditions and mass-spectrometry parameter settings.
As a process- or degradation-related impurity, Methyldopa EP Impurity B HCl (CAS 35026-10-9, C11H15NO3HCl) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Based on its molecular formula C11H15NO3HCl, Methyldopa EP Impurity B HCl contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, chlorine substitution; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 245.70 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. 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 | C11H15NO3 HCl |
| Molecular Weight | 245.70 g/mol |
| Appearance | Off-white to pale yellow crystalline powder. (slight halide-like odor) |
| 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 |
| 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 |
| CAS Registry Year (est.) | 1967 |
| Halogen Content | Cl-containing |
| Nitrogen Atoms | 1 |
Related Methyldopa Standards
- Methyldopa EP Impurity D (CAS 1369423-51-7)
- Methyldopa EP Impurity D (CAS 2799-15-7)
- Methyldopa EP Impurity D HBr (CAS 2799-15-7 (free base))
- Methyldopa EP Impurity C (CAS 39948-18-0)
- Methyldopa EP Impurity C (CAS 5486-79-3)
- DL-Methyldopa (CAS 55-40-3)
- Methyldopa EP Impurity A (CAS 6739-31-7)
- Methyldopa EP Impurity A (CAS 6739-31-7（free base）)
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- tert-Butyl 4-(1,2,3,4-tetrahydroquinolin-7-yl)piperazine-1-carboxylate (CAS 1260676-73-0)
- Lixisenatide (CAS 320367-13-3)
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