Toradol USP ≥98.5% API Pharmaceutical made in china CAS NO.74103-07-4

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%