Diclofenac impurity 4 CAS 1928-49-0
| CAS No. | 1928-49-0 |
| Molecular Formula | C9H8Cl2O3 |
| Molecular Weight | 235.06 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 impurity 4 (CAS 1928-49-0, C9H8Cl2O3) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Based on its molecular formula C9H8Cl2O3, Diclofenac impurity 4 contains a carboxylic acid group, a hydroxyl group, an ether linkage, chlorine substitution, an aromatic ring system; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 235.06 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. 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.
Physical & Chemical Properties
| Molecular Formula | C9H8Cl2O3 |
| Molecular Weight | 235.06 g/mol |
| Appearance | Off-white to pale yellow crystalline powder. (slight halide-like odor, low volatility) |
| Purity | 97%+ |
| Storage | Store in a cool place (≤25°C), 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; Hygroscopic; reseal immediately after opening; Contains ester bond; hydrolyzes under strong alkaline conditions |
| Degree of Unsaturation (DBE) | 5.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1957 |
| Halogen Content | Cl-containing |
Related Diclofenac Standards
- Diclofenac Impurity 21 (CAS 105836-68-8)
- Diclofenac Sodium Impurity 33 (CAS 58373-59-4)
- Diclofenac sodium Impurity 38 (CAS 15307-93-4)
- Diclofenac Related Compound 14 (CAS 3644-56-2)
- Diclofenac impurity 6 (CAS 860541-55-5)
- Diclofenac Impurity 41 (CAS 131023-45-5)
- Diclofenac sodium Impurity 6 (CAS 70172-33-7)
- Diclofenac Impurity N1 (CAS 131023-43-3)
Recommended Standards
- Methyl 3,5-dichloro-4-methoxybenzoate (CAS 24295-27-0)
- Dotinurad Impurity 179 (CAS CATO-C4X-2494179)
- Methyl 3,5-dichloro-2-methoxybenzoate (CAS 64122-23-2)
- 2,4-D-Methyl Ester (CAS 1928-38-7)
- Nimodipine impurity 24 (CAS CATO-C4X-138524)
- Sildenafil Impurity 302 (CAS CATO-C4X-1128302)
- Epinastine Impurity N6 (CAS 339163-80-3)
- n-(3-Ethynylphenyl)-5-nitrofuran-2-carboxamide (CAS 664303-07-5)
- b-Hydroxy-4-nitro-phenylalanine (CAS 10098-38-1)
- (4-(Methoxycarbonyl)-3,5-dimethylphenyl)boronic acid (CAS 876189-19-4)
- 2-[(propan-2-yloxy)methyl]morpholine (CAS 1216304-85-6)
- 3-Amino-N-cyclohexyl-4-methylbenzenesulfonamide (CAS 100800-56-4)
- Fmoc-Orn(Fmoc)-OH (CAS 201046-59-5)
- Insulin Degludec Impurity 1 (CAS 843666-26-2)
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