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| Test | Acceptance Criteria | Results |
| Appearance |
a white or almost white, crystalline powder. |
An almost white crystalline powder. |
| PH | 5.7~6.7 | 5.9 |
| Related substances | 1-ketone-ketorolac acid ≤ 0. 1% 1- hydroxyl-ketorolac acid ≤0. 1%； other single impurity≤ 0.5%； |
0.0030% not detected conforms |
| total impurities ≤ 1.0% | 0. 19% | |
| Loss on drying | ≤0.5% | 0. 05% |
| Residue on ignition | ≤0. 1% | 0.03% |
| Heavy Metals | ≤0.002% | Conforms |
| Assay on the dried basis | ≥98.5% | 99.4% |
| Microorganism limits | Bacteria amount: ≤ 1000/g Mould and microzyme amount: ≤ 100/g Colibacillus:should be not detected Acarid : should be not detected |
＜10/g ＜10/g not detected not detected |
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