Diclofenac Methyl Ester (Aceclofenac EP Impurity B) CAS 15307-78-5
| CAS No. | 15307-78-5 |
| Molecular Formula | C15H13Cl2NO2 |
| Molecular Weight | 310.18 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
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.
As a process- or degradation-related impurity, Diclofenac Methyl Ester (Aceclofenac EP Impurity B) (CAS 15307-78-5, C15H13Cl2NO2) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Diclofenac Methyl Ester (Aceclofenac EP Impurity B) (C15H13Cl2NO2) contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, chlorine substitution. 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 high carbon-to-hydrogen ratio imparts good lipophilicity, allowing liquid-liquid extraction with non-polar solvents such as n-hexane or ethyl acetate.
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.
Physical & Chemical Properties
| Molecular Formula | C15H13Cl2NO2 |
| Molecular Weight | 310.18 g/mol |
| Appearance | Pale yellow to yellow crystalline powder. (slight halide-like odor, low volatility) |
| Purity | >95% |
| Storage | Store at 2-8°C, protect from light |
| Solubility (reference) | Soluble in chloroform, dichloromethane, ethyl acetate, DMSO |
| Stability | May oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Contains ester bond; hydrolyzes under strong alkaline conditions |
| Degree of Unsaturation (DBE) | 9.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1961 |
| Halogen Content | Cl-containing |
| Nitrogen Atoms | 1 |
Related Diclofenac Standards
- Diclofenac sodium Impurity 48 (CAS 66156-75-0)
- Diclofenac Related Compound 1 (CAS 928343-25-3)
- Diclofenac sodium Impurity 63 (CAS 1254576-93-6)
- Diclofenac Impurity 42 (CAS 944251-06-3)
- Diclofenac Impurity 44 (CAS 69002-85-3)
- Diclofenac Impurity 23 (CAS CATO-C4X-105123)
- Diclofenac impurity f (CAS 124426-56-8)
- Diclofenac sodium Impurity 37 (CAS 15308-01-7)
Recommended Standards
- Clevidipine Butyrate impurity 18 (CAS 105383-68-4)
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- tert-Butyl 5-bromo-6-methyl-1H-indole-1-carboxylate (CAS 1072157-39-1)
- Ibrutinib Impurity 51 (CAS CATO-C4X-106451)
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- 2,4,6-Trichloropyrimidine-5-carboxamide (CAS 1710340-83-2)
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- 4-(4-Vinylphenyl)-1H-imidazole (CAS 937013-08-6)
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