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| Item | Criteria | Analysis Resultes |
|---|---|---|
| Appearance | White or off-white powder | Off-white powder |
| Identification-IR | Conform to the reference spectrum | Conform |
| Identification-HPLC | Conform to the reference standard | Conform |
| Loss on drying | ≤0.5% | 0.12% |
| Chloride | ≤0.005% | <0.005% |
| Residual solvents | ||
| Methanol | ≤3000ppm | 200ppm |
| Dichloromethane | ≤600ppm | Not detected |
| Dimethyl sulfoxide | ≤5000ppm | Not detected |
| Related compounds | ||
| Impurity A | ≤0.3% | 0.07% |
| Any individual impurity | ≤0.1% | 0.03% |
| Total impurities | ≤0.5% | 0.15% |
| Residue on ignition | ≤0.1% | 0.04% |
| Heavy metals | ≤0.001% | <0.001% |
| Assay | ≥99.0% | 99.7% |
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