Domperidone Impurity 8 CAS 53786-45-1
| CAS No. | 53786-45-1 |
| Molecular Formula | C14H20ClN3O2 |
| Molecular Weight | 297.78 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 297.78 g/mol gives Domperidone Impurity 8 distinctive chromatographic separation conditions and mass-spectrometry parameter settings.
As a process- or degradation-related impurity, Domperidone Impurity 8 (CAS 53786-45-1, C14H20ClN3O2) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Structurally, Domperidone Impurity 8 (C14H20ClN3O2) contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, chlorine substitution. The molecule exhibits a degree of unsaturation (DBE) of 6.0, corresponding to approximately 6 ring(s) or double-bond equivalent(s). With a molecular weight of 297.78 g/mol, it falls into the medium-molecular-weight range. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).
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 | C14H20ClN3O2 |
| Molecular Weight | 297.78 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 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) | 6.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1972 |
| Halogen Content | Cl-containing |
| Nitrogen Atoms | 3 |
Related Domperidone Standards
- Domperidone Impurity 12 (CAS 107618-26-8)
- Domperidone Impurity 28 (CAS CATO-C4X-142028)
- Domperidone Impurity 11 (CAS 85443-52-3)
- Domperidone Impurity 16 (CAS 39677-10-6)
- Domperidone Impurity 15 (CAS 142799-22-2)
- Domperidone Impurity 30 (CAS CATO-C4X-142030)
- Domperidone Impurity 29 (CAS CATO-C4X-142029)
- Domperidone EP Impurity B (CAS 1346598-11-5)
Recommended Standards
- Atazanavir Impurity 14 (CAS 102123-74-0)
- 6-Chloro-N-(2-morpholin-4-ylethyl)-1,3-benzothiazol-2-amine (CAS 1105189-23-8)
- Ivabradine Impurity 27 (CAS 85175-65-1)
- 4-Chloro-N-(2-morpholin-4-ylethyl)-1,3-benzothiazol-2-amine (CAS 1177311-69-1)
- Imidacloprid Impurity 1 (CAS 105828-41-9)
- Lifitegrast Impurity 128 (CAS CATO-C4X-2409128)
- Ulipristal Impurity 28 (CAS 42982-49-0)
- Ethyl 4-(4-methoxyphenyl)-1,3-thiazole-2-carboxylate (CAS 886366-42-3)
- Methyl 2-methyl-1,3-dioxoisoindoline-4-carboxylate (CAS 1707375-46-9)
- 2,8-Dimethylquinoxalin-6-amine (CAS 103139-95-3)
- (9E,11E)-9,11-Tetradecadien-1-ol (CAS 72553-58-3)
- Methyl 7-methyl-2,4-dioxo-1-(2-phenylethyl)-1,2,3,4-tetrahydropyrido[2,3-d]pyrimidine-6-carboxylate (CAS 1324060-47-0)
- 2-(Tetrahydro-2H-pyran-2-yl)pyridin-4-amine (CAS 1622835-04-4)
- Exenatide (CAS 141758-74-9（free base）)
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