| Grade Standard: | Medicine Grade |
|---|---|
| State: | Powder |
| Volatile: | Not Volatile |
| Assay: | 99%Min |
| Transport Package: | Drum |
| Specification: | 25kg/drum |
| Samples: |
|---|
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Audited Supplier | Test | Specification | Results |
| Description | Appearance:White or almost white crystalline powder | Almost white crystalline powder |
| Identification |
IR:concordant with the spectrum obtained with Ketorolac tromethamine CRS. | Conforms |
| TLC:color and position of principal spot obtained with test solution consistent with that of the reference solution |
Conforms | |
| pH | 5.7-6.7 | 6.0 |
| Related substance | Impurity RRT0.54:NMT 0.5% | undetectable |
| Impurity RRT0.66:NMT 0.5% | 0.0040% | |
| Ketorolac 1-keto analog:NMT 0.1% | 0.0031% | |
| Ketorolac 1-hydroxyl analog:NMT 0.1% | undetectable | |
| Any other single impurity:NMT 0.5% | 0.079% | |
| Total impurities:NMT 1.0% | 0.15% | |
| Residual solvents | Dichloroethane:NMT 5ppm | undetectable |
| Anhydrous ethanol:NMT 5000ppm | 503ppm | |
| Loss on drying | NMT 0.5% | 0.02% |
| Residue on ignition | NMT 0.1% | 0.04% |
| Heavy metals | NMT 20ppm | <20ppm |
| Microorganism Limits | Bacteria amount:NMT 103cfu/g | <lcfu/g |
| Mould and yeast amount:NMT 102cfu/g | <lcfu/g | |
| Escherichia.Coli:A bsent | Absent | |
| Bacterial Endotoxin | NMT 5EU/mg | <5EU/mg |
| Assay (on the dried basis) |
98.5%~101.5% | 99.3% |
| Storage | Preserve in tight, light-resistant containers. Store at 25, excursions permitted between 15°and30°. | |
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