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Tinidazole
| ITEMS | LIMIT |
| Appearance | White or pale yellow crystalline powder |
| Solubility | Practically insoluble in water, soluble in acetone and in methylene chloride, sparingly soluble in methanol |
| Melting range | 125-128 |
| Identification | The IR spectrum corresponds to Tinidazole reference standard |
| Appearance of solution | 5.0%(g/ml)solution in acetone should be clear and not more intensely colored than reference solution Y5 |
| Related substances(TLC) | Impurity-A:NMT 0.5% |
| Impurity-B:NMT 0.5% | |
| Any other unspecified impurity: NMT 0.5% | |
| At most one impurity more than 0.2% | |
| Residual solvents(GC) | Ethanol: NMT 1000 ppm |
| O-xylene: NMT 195.3 ppm | |
| Loss on drying | NMT 0.5% |
| Sulphated ash | NMT 0.1% |
| Heavy metals | NMT 20 ppm |
| Assay | NLT 98.0% & NMT 101.0% (dried substance) |
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