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Items of Analysis | Standard of Analysis | Test Results |
Appearance | Yellow crystalline powder | Yellow crystalline powder |
pH | 5.5-7.0 | 6.23 |
Colour of solution | No darker than No.5 standard solution | Conform |
Melting point | 186-189℃ | 187.5-188.5℃ |
Residual Solvents | DMF ≤880ppm | ND |
Methanol ≤3000ppm | ND | |
Dichloromethane ≤600ppm | ND | |
Related substances | Any impurity ≤0.1% | 0.08% |
Total impurities ≤0.5% | 0.16% | |
Loss on drying | ≤0.5% | 0.08% |
Sulphated ash | ≤0.1% | 0.02% |
Assay | 98.5-101.5% | 100.7% |
Conclusion | Conforms to Factory Standard |
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