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Items of Analysis | Standard of Analysis | Test Results |
Appearance | White to off-white powder | Conforms |
Identification | IR spectrum UV spectrum Reaction of Chlorides | Conforms Conforms Positive |
Heavy metals(USP) | NMT 0.005% | <0.005% |
Loss on drying(USP) | NMT 1.0% | 0.2% |
Residue on ignition | NMT 0.1% | <0.1% |
Related substances-sum: -TLC(USP) -HPLC | NMT 2.0% NMT 1.0% | <2.0% 0.8% |
Assay(in the dried substance): -titration(USP) | 98.0-100.5% | 99.7% |
Residual solvents: -Methanol -Ethanol -Acetonitrile -Toluene | NMT 3000ppm NMT 5000ppm NMT 410ppm NMT 890ppm | Not detected Conforms Not detected Not detected |
Conclusion | Conforms to USP 39 |
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