| Test |
Specification |
| Description |
Appearance |
Yellowish, amorphous powder |
| Solubility |
Freely soluble in water, sparingly soluable in dimethylformamide, practically insoluable in ethanol (96) |
| Identification |
IR |
Concordant with reference Standard |
| HPLC |
Concordant with reference Standard |
| Appearance of solution |
The solution is clear and not more intensely colored than reference solution BY3 or B4 |
| pH (0.5 g per 10mL) |
Between 6.5 ~ 7.5 |
| Composition and related substances (by HPLC) |
Teicoplanin A2 group |
Not less than 80.0% |
| Teicoplanin A2-1 group |
Not more than 20.0% |
| Teicoplanin A2-2 |
35.0 to 55.0% |
| Teicoplanin A2-3 group |
Not more than 20.0% |
| Teicoplanin A2-4 |
Not more than 20.0% |
| Teicoplanin A2-5 group |
Not more than 20.0% |
| Teicoplanin A3 group |
Not more than 15.0% |
| Total impurities other than mesityl oxide |
1.25 to 5.0% |
| Chlorides (Calculated on NaCl and anhydrous basis |
Not more than 5.0% |
| Heavy metals |
Not more than 0.002 % |
| Impurity A (Mesityl Oxide) |
Not more than 0.2% |
| Water [%w/w by KF] |
Not more than 15.0 % |
| Bacterial Endotoxins |
Not more than 0.31IU/mg |
| This is EP version. Specification will be changed for USP/IP/JP/Ph.Eur |
