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1 Kilogram |
Negotiable |
Toradol Ketorolac Tromethamine Ketorolac
≥98.5% We have GMP
Ketorolac Tromethamine
Appearance |
White or almost white crystalline powder |
Identification |
UV:scan at 200nm~400nm,concordant with the spectrum obtained with ketorolac tromethamine CRS |
|
IR:concordant with the spectrum obtained with ketorolac tromethamine CRS |
|
TLC:color and position of principal spot obtained with test solution consistent with that of the reference solution |
PH |
5.7~6.7 |
Related substance |
Impurity RRT0.54:≤0.5% |
|
ImpurityRRT0.66:≤0.5% |
|
Ketorolac 1-keto analog:≤0.1% |
|
Kerorolac1-hydroxyl analog:≤0.1% |
|
Any other single impurity:≤0.5% |
|
Total impurities:≤1.0% |
Residual solvents |
Dichloroethane:≤5ppm |
|
Anhydroous ethanol:≤5000ppm |
Loss on drying |
≤0.5% |
Residue on ignition |
≤0.1% |
Heavy metals |
≤20ppm |
Microorganism limits |
Bacteria amount:≤1000cfu/g |
|
Mould and yeast amount:≤100cfu/g |
|
Escheriohia coli:N,D |
Assay |
98.5~101.5% |
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