Product name

Polymyxin B sulfate Sterile

CAS:

1405-20-5

Batch No.

12242012

Report Date

2012.12.24

Quantity

3BOU

Retest period:

2017.12.23

Contents of testing 

Specifications

Results

Appearance

White or almost white crystalline powder, hygroscopic

Complies

Solubility

Freely soluble in water, slightly soluble in alcohol

Complies

Identification

A. Liquid chromatographic identification test

B. A reddish violet color is produced

C. Test for sulpharte

Complies

PH(2%)

5.0~7.0

5.76

PH(0.5%)

5.0~7.5

5.68

Specific rotation

-78° ~ -90°

-80.0°

Loss on drying

Not more than 7.0%

4.6%

Phenylalanine

9.0%~12.0%

10.40%

Sulfated Ash

Not more than 0.75%

0.34%

Sulfate

15.5%~17.5%

15.8%

Heavy metal

Not more than 20ppm

<20PPM

Sterility

Meets the requirements

Complies

Assay (Microbial)

(On dried basis)

NOT LESS THAN 6500IU/MG

8770IU/MG

Particle Size

99.0%: Not more than 30μm by vol.

90.0%: Not more than 25μm by vol.

75.0%: Not more than 20μm by vol.

Mean Diameter:Not more than 8.0μm.

Complies

Conclusion

The result conforms to the standard of USP30.

Storage

Preserve in well-closed, light-r; resistant&tight containers; in cool&dry place.

Temperature for transport

From 0 to 45°C(Floating range: 5°C)

Temperature for storage

From 2 to35°C(Floating range: 3°C)