TESTS |
SPECIFICATIONS |
RESULTS |
Appearance |
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 |
Conforms |
TLC:color and position of principal spot obtained with test solution consistent with that of the reference solution |
Conforms |
|
IR |
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% |
0.0027% |
1-hydroxyl-ketorolac acid≤0.1% |
N.D |
|
Other single impurity≤0.5% |
0.12% |
|
Total impurities≤1.0% |
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 |
Packaging details:
Packaging details: |
25kg/drum with double plastic bags inside; packed in a cardboard drum or fiber HDPE drum. |
Storage: |
Stored in a clean, cool, dry area; keep away from moisture and strong, direct light/heat |
Shelf Life: |
5 years if sealed and store away from direct sun light. |