| SPECIFICATIONS | STANDARD BP2007 | RESULTS |
| APPEARANCE | White or almost white powder | Conforms |
| IDENTIFICATION |
UV: similar to reference standard(285+/-2nm)
IR: similar to the reference standard |
Conforms |
| RESIDE ON IGNITION | ≤0.1% | 0.03% |
| HAEVY METALS | ≤20ppm | Conforms |
| LOSS ON DRYING | ≤0.3% | 0.11% |
| MELTING POINT | 164-168°C | 166-167°C |
| 5-Methylisoxazole-carboxylic acid | ≤0.1% | 0.06 |
| Leflunomide related compound A | ≤0.01% | NONE |
| Leflunomide related compound B | ≤0.3% | NONE |
| N-(2'-Trifluoromethyphenyl)-5-methylisoxzole-4-carboxomide | ≤0.1% | NONE |
| 2-Cyano-acetic acid-(4'-trifluoromethyl)-anilide | ≤0.1% | NONE |
| Leflunomide related compound C | ≤0.1% | 0.004 |
| Total impuritie (excluding leflunomide related compound B and leflunomide related compound C ) | ≤0.2% | 0.1% |
| Any other individual impurity | ≤0.1% | ≤0.1% |
| Total impurities | ≤0.4% | 0.15% |
| Assay | 98.0-102.0% | 99.84% |
| PACKAGING AND STORAGE:Preserve in a well-closed container, store at a temperature not exceeding 30°C. | ||
| CONCLUSION: THE PRODUCT CONFORMS TO BP2007 STANDARD. | ||