CAS number： 74103-07-4
Molecular formula： C19H24N2O6
molecular weight： 376.4
Chemical structure：
| Sr No. | Test | Specification | Result | |||
| 1 | Description | White to off- white crystalline powder melts between 1650C and 1700C with decomposition. | Almost white crystalline powder | |||
| 2 | Solubility | Freely soluble in water and in methanol. Slightly soluble in alcohol, in dehydrated alcohol and in THF. Practically insoluble in Acetone, in MDC, in Toluene, in Ethyl Acetate , in Dioxane , in Hexane , in Butyl Alcohol and in Acetonitrile | Complies | |||
| 3 | Identification by | |||||
| a) By IR | IR of sample spectrum should match with that of Working Standard Spectrum | Complies | ||||
| b) By UV | As per USP | Complies | ||||
| c) Tromethamine test | Should pass test | Complies | ||||
| 4 | pH ( 1 in 100 ) | Between 5.70 and 6.70 | 5.89 | |||
| 5 | Loss on drying | NMT 0.5 % | 0.18 % | |||
| 6 | Residue on ignition | NMT 0.1 % | 0.06 % | |||
| 7 | Heavy metals | NMT 0.002 % | Less than 0.002 % | |||
| 8 | Chromatographic purity | |||||
| 9 | Impurity having a 0.54 RRT | NMT 0.5 % | Not detected | |||
| Ketorolac-1-hydroxyl analog | NMT 0.1 % | Not detected | ||||
| Impurity having a 0.66 RRT | NMT 0.5 % | Not detected | ||||
| Ketorolac 1-keto analog | NMT 0.1 % | 0.044 % | ||||
| Any other individual unknown impurity | NMT 0.5 % | 0.014% | ||||
| Total impurities | NMT 1.0 % | 0.061% | ||||
| Assay by HPLC | 98.5 % to 101.5 % | 99.70 % | ||||
