| Product: | DICLOFENAC SODIUM | |
| Shelf Life | 4 years | |
| ITEMS | SPECIFICATION | RESULTS |
| Appearance | A white or silightly yellowish crystalline powder | White crystalline powder |
| Identification | A.IR | CONFORM |
| D.Test of sodium salt | CONFORM | |
| Appearance of solution | The solution is clear and its absorbance at 440 nm is not greater than 0.05 | Clear, 0.009 |
| Related substances | Impurity A:NMT0.2% | <0.05% |
| Impurity F:NMT0.15% | <0.05% | |
| Any specified individual impurity:NMT0.10% | <0.05% | |
| Total impurities:NMT0.4% | 0.069% | |
| Heavy metals | NMT 10 PPM | <10ppm |
| Loss on drying | NMT 0.5%(1g,105℃,3hrs) | 0.04% |
| Assay | 99.0~101.0%(dried substance) | 100.2% |
| Conclusion:It accords with BP2015.Be up to the standard. | ||