WHITE OR ALMOST WHITE POWDER, HYGROSCOPIC

CONFORMS

CONFORMS

5.0～7.0

6.6

PH(5%)

5.0～7.5

6.4

SPECIFIC ROTATION

-78°～-90°

-88°

PHENYLALANINE

9～12%

11.0%

LOSS ON DRYING

NOT MORE THAN 6.0%

1.2%

SULPHATED ASH

NOT MORE THAN 0.75%

0..0%

SULPHATE

15.5～17.5%

17.3%

RELATED SUBSTANCES

(BY HPLC)

SIGLE IMPUIRITY: NOT MORE THAN 3.0

TOTAL IMPURITIES: NOT MORE THAN 17.0%

3.2%

14.3%

HEAVY METALS

NOT MORE THAN 20PPM

<20PPM

STERILITY

MEET THE REQUIREMENTS

CONFORMS

PYROGENS

MEET THE REQUIREMENTS

CONFORMS

ASSAY (AS IS)

NOT LESS THAN 6500 IU/MG

8260 IU/MG, 826 UG/MG

ASSAY HPLC (ODB)

SUM OF POLYMYXINS B1, B2, B3 AND B1-1: NOT LESS THAN 80.0%

POLYMYXIN B3: NOT MORE THAN 6.0%

POLYMYXIN B1-1: NOT MORE THAN 15.0%

85.4%

3.8%

8.1%