Ketorolac

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:

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.