Product Name: COLISTIN SULPHATE

CHARACTER

WHITE OR ALMOST WHITE POWDER

WHITE POWDER

IDENTIFY

IS ACCORDED WITH STANDARD

CONFORM

PH

4.0~6.0

4.83

LOSE ON    DRY

≤3.5%

2.2%

SPECIFIC    OPTICAL ROTATION

-63°~ -73°

-70°

SULPHATE    ASH

≤1.0%

0.21%

SULPHATE

16.0%~18.0%

16.7%

CONTENT    (DRY BASIS HPLC)

COLISTIN E1-I: ≤10.0%
     COLISTIN E1-7MOA: ≤10.0%
     COLISTIN E3: ≤10.0%
     E1+E2+E3+E1-I+E1-7MOA: ≥77.0%

0.57%
     3.6%
     5.3%
     85.0%

RELATED    SUBSTANCES

ANY IMPURITY: ≤4.0%
     TOTAL IMPURITY: ≤23.0%

2.8%
     14.4%

ASSAY    (ON WET BASIS)

;

22400IU/MG

POTENCY    (DRIED SUBSTANCE)

≥19000IU/MG

22904IU/MG