APIs
Etodolac - EP/BP
| Sl. No. | Test Parameter | Specification |
| 1 | Description | A White or almost white, crystalline powder. |
| 2 | Solubility | Water : Practically insoluble Acetone : Freely soluble Ethanol : Freely soluble |
| 3 | Identification a) IR b) TLC |
IR absorption Spectrum matches the Standard Spectrum. TLC matches with that of the reference standard |
| 4 | Melting Range | 144OC-150OC |
| 5 | Water content (KF) | NMT 0.5% |
| 6 | Sulphated ash | NMT 0.1% |
| 7 | Limit of chloride | NMT 300 ppm |
| 8 | Assay on dry basis | 98.0% - 102.0% |
| 9 | Related Substances by HPLC | Impurity A NMT 0.2% Impurity B NMT 0.2% Impurity C NMT 0.5% Impurity D NMT 0.2% Impurity E NMT 0.2% Impurity F NMT 0.2% Impurity G NMT 0.2% Impurity H NMT 0.2% Impurity I NMT 0.2% Impurity K NMT 0.2% Unspecified Impurity NMT 0.10% Total Impurity NMT 1.0% |