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Technical Specifications
| Tests | Specifications | Results |
|---|---|---|
| Appearance | White or almost white crystalline powder | White crystalline powder |
| Identification | IR: The IR absorption spectrum of sample corresponds to that of reference one | Complies |
| Loss on drying | Not more than 0.5% | 0.10% |
| Residue on ignition | Not more than 0.2% | 0.03% |
| Related substances | ||
Impurity A Impurity X3 Unspecified impurity Total impurities |
Not more than 0.3% Not more than 0.15% Not more than 0.10% Not more than 0.5% |
0.10% 0.08% 0.04% 0.26% |
| Impurity B | Not more than 0.01% | N.D |
| Assay | 98.0%~102.0% ( Calculated on dried basis) |
99.40% |
| Conclusion | Complies with BP | |