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Items of Analysis | Standard of Analysis | Test Results |
Characters | White or practically white crystalline powder, practically odorless | Conforms |
Soluble | Slightly soluble in water; freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethylformamide; sparingly soluble in methanol; insoluble in ether, in chloroform, and in dilute mineral acids. | Conforms |
Identification | IR,UV | Conforms |
Loss on drying | ≤0.5% | 0.1% |
Residue on ignition | ≤0.1% | 0.04% |
Chloride | ≤0.035% | Conforms |
Selenium | ≤0.003% | Conforms |
Heavy metals | ≤ 0.001% | Conforms |
Related compounds | Benzothiadiazine related compound A ≤ 1.0% | 0.4% |
Any other impurities≤ 0.5% | Conforms | |
Total other impurities ≤0.9% | 0.5% | |
Organic volatile impurities | Meets the requirements | Conforms |
Assay | 98.0~102.0% | 100.1% |
Conclusion | Conforms to USP42 |
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