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Ketorolac Tromethamine

Toradol

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Specifications:
PRODUCT NAME: Ketorolac Tromethamine
CAS NUMBER: 74103-07-4

MP 160-161°C
storage temp.
Hygroscopic, Refrigerator, Under Inert Atmosphere
solubility H2O: 15 mg/mL stable at least one month at −20 °C., soluble
Usage Analgesic; Cyclooxygenase Inhibitor; anti-inflammatory.
Analysis Test Specification Result
Description White or almost white, crystalline powder Almost white crystalline powder
Solubility Freely soluble in water and in methanol; slightly soluble in alcohol, in dehydrated alcohol, and in tetrahydrofuran; practically insoluble in acetone, in dichloromethane, in toluene, in ethyl acetate,in dioxane, in hexane, in butyl alcohol, and acetonitrile. Conforms
Identification UV: Maximum absorption at 243nm, 318nm. Minimum absorption at 268nm

TLC: color and position of principal spot obtained with test solution consistent with that of the reference solution

IR

Conforms

Conforms

Conforms

pH 5.7~6.7 6.1
Melting range 165~170°C 166~168°C
Clarity and color of solution The solution should be clear and colorless ,if not ,not more intensely turbid than No.1 reference solution and not more intensely colored than reference solution of Y1 Conforms
Related substances 1-ketone-ketorolac acid≤0.1%
1-hydroxyl-ketorolac acid≤0.1%
Other single impurity≤0.5%
Total impurities≤1.0%
0.0027%
N.D
0.12%
0.17%
Dichloromethane Peak area of dichloromethane in test solution is not more than that of reference solution N.D
Loss on drying ≤0.5% 0.08%
Residue on ignition ≤0.1% 0.09%
Heavy metals ≤0.002% Conforms
Assay (on the dried basis) 98.5~101.5% 99.2%
Conclusion The product meets the requirements of USP

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