Ketorolac tromethamine NEW

Appearance

White or almost white crystalline powder

Conforms

Identification

Infrared spectrum:he infrared absorption spectrum of   this product should be consistent with that of the reference substance.

Conforms

Liquid chromatogram:The retention time of the main   peak of the test solution in the chromatogram recorded under the content   determination item should be consistent with the retention time of the main   peak of the standard solution

Conforms

TLC:A yellow spot with a pink to purple border   appears in the spot area of the standard solution and sample solution on the   plate

Conforms

Residue on ignition

The residual residue shall not exceed 0.1%

0.04%

Organic impurities

Impurities with a relative retention time of 0.54   should not exceed 0.5%

Undetectable

Ketorolac l-hydroxy analogues do not exceed 0.1%

undetectable

Ketorolac l-keto analogs should not exceed 0.1%

undetectable

Impurities with a relative retention time of 0.66   should not exceed 0.5%

undetectable

Ketorolac l-keto analogs should not exceed 0.1%

0.0044%

Residual solvent

Methanol must not exceed 3000ppm

undetectable

Ethanol must not exceed 5000ppm

400ppm

Toluene should not exceed 890ppm

undetectable

benzene

Benzene should not exceed 2ppm

undetectable

1.2-Dichloroethane

1.2-Dichloroethane should not exceed 5ppm

undetectable

Carbon tetrachloride

Must not exceed 4ppm

undetectable

ph

5.7~6.7

5.9

Dryness and weightlessness

No more than 0.5%

0.09%

Bacterial endotoxin

Must not exceed 4EU/mg

＜4EU/mg

Content determination

Calculated by dry product,98.5%~101.5%

99.5%

Conclusion

The product conforms to the   above specifications.