Flumazenil EP Impurity D CAS 78755-80-3
| CAS No. | 78755-80-3 |
| Molecular Formula | C10H9FN2O2 |
| Molecular Weight | 208.19 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
The occurrence of Flumazenil EP Impurity D is closely related to a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, fluorine substitution in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.
As a process- or degradation-related impurity, Flumazenil EP Impurity D (CAS 78755-80-3, C10H9FN2O2) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Flumazenil EP Impurity D (C10H9FN2O2) contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, fluorine substitution. It is notably hygroscopic, halogen substitution raises its density and boiling point, its high carbon-to-hydrogen ratio confers good lipid solubility, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. 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 | C10H9FN2O2 |
| Molecular Weight | 208.19 g/mol |
| Appearance | Off-white to pale yellow crystalline powder. (slight halide-like odor, faint amine-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) | 7.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1979 |
| Halogen Content | F-containing |
| Nitrogen Atoms | 2 |
Related Flumazenil Standards
- Flumazenil Impurity 10 (CAS 162110-24-9)
- Flumazenil Impurity 9 (CAS 5973-29-5)
- Flumazenil Impurity 22 (CAS 193693-31-1)
- Flumazenil Impurity 13 (CAS CATO-C4X-143213)
- Flumazenil Impurity 19 (CAS 548487-68-9)
- Flumazenil Impurity 17 (CAS 116569-09-6)
- Flumazenil EP Impurity C (CAS 1188-33-6)
- Flumazenil EP Impurity A (CAS 84378-44-9)
Recommended Standards
- Sildenafil Impurity 56 (CAS CATO-C4X-112856)
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- Selexipag Impurity 32 (CAS 31600-69-8)
- Ticagrelor Impurity 105 (CAS 1858267-99-8)
- Bumetanide Impurity 52 (CAS CATO-C4X-198652)
- 1-Phenyl-1H-1,2,4-triazole-3,5-diamine (CAS 14575-59-8)
- Mitiglinide Impurity 11 (CAS CATO-C4X-116111)
- Ethyl 5-(2-ethoxyphenyl)isoxazole-3-carboxylate (CAS 668971-91-3)
- tert-butyl 1-(prop-2-yn-1-yl)piperidine-4-carboxylate (CAS 2031268-95-6)
- 2-(4-(Benzylsulfonyl)piperazin-1-yl)-4,6-dimethylnicotinonitrile (CAS 478081-75-3)
- Iopamidol Impurity 45 (CAS CATO-C4X-145045)
- Calcium-Like Peptide 3 (CAS 261969-05-5)
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