| ITEM | STANDARD | RESULTS |
| Appearance | Yellowish,amorphous powder | Yellowish,amorphous powder |
| Identification | IR conforms HPLC,the principal peaks in the chromatogram obtained with the test solution are similar in retention time and size to the principal peaks in the chromatogram obtained with reference solution |
Conforms |
| Appearance of solution | The solution is clear and not more intensely coloured than reference solution BY3 OR B4 | Conforms |
| pH | 6.5 to 7.5 | 7.0 |
| Composition and related substances,% | teicoplanin A2 group: more than 80.0; teicoplanin A2-2 group:35.0 to 55.0; teicoplanin A2-1 group:≤20.0; teicoplanin A2-3 group:≤20.0; teicoplanin A2-4 group:≤20.0; teicoplanin A2-5 group:≤20.0; teicoplanin A3 group:≤15.0; Total of impurities other than mesityl oxide with a relative retention more than 1.25:≤5.0 per |
87.8 43.9 6.4 13.7 14.3 9.6 10.2 |
| Chlorides,% | ≤5 | 0.4 |
| Heavy metals,ppm | ≤20 | Less than 20 |
| Water,% | ≤15.0 | 4.4 |
| Impurity A,% | ≤0.2 | 0.1 |
| Bacterial endotoxin ,IU/mg | ≤0.31 | ≤0.31 |
| Bacterial endotoxins | ≤0.73EU/mg | Complies |
| Residual solvents,ppm | Methanol≤3000 Ethanol≤5000 Acetone≤5000 |
0 0 0 |
| Assay,IU/mg | More than 900 | 933 |
