Tests

Specifications

Results

Appearance

White to pale buff powder

White powder

Identification

TLC,Conforms  

Conforms

HPLC,Conforms  

pH

5.5 ~ 7.5

6.5

Loss on drying

≤ 5.0%

1.5%

Residue on ignition

≤ 0.5%

0.2%

Bacitracin A

≥ 40.0%

68.9%

Sum of bacitracin A、

B1、B2 and B3

≥ 70.0%

86.6%

Limit of early eluting peptides

≤ 20.0%

3.1%

Limit of Bacitracin F

≤ 6.0%

2.4%

Microbial assay (Dried basis)

≥ 65 IU/mg

79.1IU/mg

Heavy metals

≤30ppm

Conforms

Total viable aerobic count

≤100 CFU/gram

Conforms

Particle size

Min.99.0% ≤ 20.0µm by volume

99.7%

Conclusion: complies with current USP

Storage:Preserve in light containers and store below 8℃.