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Dantrolene sodium
| ITEMS | LIMIT |
| Appearance | Yellowish-orange to orange crystalline powder. No visible evidence of contamination by foreign matter |
| Identification A | The Irabsorption spectrum exhibits maxima only at the same wavelengths as that of the reference standard(197K) |
| Identification B | The retention time of the major peak in the chromatogram of the assay preparation corresponds to that in the chromatogram of the standard preparation, as obtained in the assay. |
| Identification C | Meets thre requirements of the flame test for sodium(191) |
| heavy metals | Not more than 0.002% |
| Water | 14.5%-17.0% |
| Assay | 90.0-96.0% of C14H10N4O5 On the anhydrous basis |
| Residual solvents | Ethanol Not more than 2000ppm |
| Methanol Not more than 500ppm | |
| Acetone Not more than 200ppm | |
| DMF Not more than 620ppm | |
| Related substances | Related compound A Not more than 0.15% |
| Related compound B Not more than 0.50% | |
| Related compound C Not more than 0.30% |
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