Item | Specification | Result | |
Description | White or almost white, crystalline powder | White crystalline powder | |
Identification | IR spectrum is consistent with etodolac RS | Conforms | |
Water | ≤0.5% | 0.07% | |
Residue on ignition | ≤0.1% | 0.02% | |
Limit of Chloride | ≤0.03% | 0.001% | |
Heavy metals | ≤0.001% | <0.001% | |
Limit of alcohol and methanol | Methanol≤0.1% | <LOD (10ppm) | |
Alcohol≤0.1% | 0.01% | ||
Chromatographic purity | Related components A≤0.5% | 0.12% | |
Any unknown impurity≤0.10% | 0.04% | ||
Total impurities≤2.0% | 0.17% | ||
Assay | 98.0-102.0% | 99.5% | |
Particle size | D(v.o.9)≤10um | Conforms |