Test | Specifications | Batch I | Batch II |
Assay | 95% - 105% asper BP | 106.5% | 105.7% |
90% - 120% asper USP | |||
4-epidoxycycline | <0.5%* | 0.14% | 0.13% |
Metacycline | <2% | 0.66% | 0.15% |
6-epidoxycycline | <2% | 1.15% | 1.12% |
Maximum unknown impurity | <0.5% | ND** | ND** |
Total impurities | N/A** | 1.95% | 1.39% |