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%