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 % |