Tests

Specifications

Results

Appearance

White to pale tan powder

White powder

Identification

Meets the requirements of the test for composition of Bacitracin

Conform

Meets the requirement of the test for Zinc content

Conform

pH

6.0 ~7.5

6.5

Loss On Drying

5.0%Max

2.3%

Zinc (Dried basis)

4.0% ~ 6.0%

5.2%

Bacitracin A

≥40%

68.1%

Sum of bacitracin A,B1,B2 and B3

≥70%

85.90%

Limit of early eluting peptides

≤20.0%

2.0%

Bacitracin F

≤6.0%

4.2%

Microbial assay (Dried Basis)

≥65IU/mg

77.1IU/mg

Total viable aerobic count

≤100CFU/gram

Conforms

Particle Size

Min 99.0% ≤20um by volume

99.7%

Conclusion

Comply with current USP

Storage

Reserve in tight containers and store below 25℃