Item

Specifications

Results

Characters

White Powder

White 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  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

2.0

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