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Secnidazole
| ITEMS | LIMIT |
| Description | Secnidazole is structurally related to the commonly used 5-nitroimidazoles metronidazole and tinidazole. These drugs share a common spectrum of activity against anaerobic micro-organisms and they appear particularly effective in the treatment of amoebiasis, giardiasis, trichomoniasis and bacterial vaginosis. Secnidazole is rapidly and completely absorbed after oral administration and has a longer terminal elimination half-life (approximately 17 to 29 hours) than commonly used drugs in this class. in patients with intestinal amoebiasis or giardiasis, clinical or parasistological cure rates of 80 to 100% are achieved after treatment with a single dose of secnidazole 2g (30 mg/kg in children), similar to the response rates achieved with multiple dosage regimens of metronidazole or tinidazole. |
| Appearance | A white to pale yellow crystal or crystalline powder |
| Solubility | Freely soluble in Ethanol, soluble in chloroform, sparinglyoluble in water or ethyl ether, freely soluble in dilute acid. |
| Ultraviolet absorbance | The absorbance (E 1cm 1%) of the solution(13ug/ml) in hydrochloride acid(9-1000) should be 331-349 at 277nm |
| Identification | Chemical reaction: Matches with standard |
| UV: Max 277 nm, min 241 nm | |
| IR: Matches with standard | |
| Melting range | 68 to 78 °C |
| Clarity of Ethanol solution | 2% w/v in Ethanol should be clear |
| Solubility in dilute acid | 5% w/v in 1 N HC1 should be freely soluble |
| pH | 5.5-7.5, determined in 1% w/v solution in water |
| Water content (KF) | ≤6.0% |
| Residue on ignition | ≤0.1% |
| Heavy metals | ≤20ppm |
| Related substances | 2-methyl-5-nitronimidazole: ≤0.5% |
| Any other individual impurity: ≤0.5% | |
| Total impurities | ≤1.0% |
| Residual solvent | Dichloromethane ≤300ppm |
| Ethyl acetate≤1000ppm | |
| Assay (on anhydrous basis) | 98.0% ~ 102.0% |
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