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Certificate of Analysis
Product Name: Bacitracin Zinc USP
Batch No.: 211203 Batch Size: 41.46KG
Mfg.Date: 2021.12.13 Report Date: 2021.12.19
Retest Date: 2023.12.12
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Tests |
Specifications |
Results |
|
Appearance |
White to pale tan powder |
White powder |
|
Identification |
Meets the requirements of the test for Composition of Bacitracin |
Conforms |
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Meets the requirements of the test for Zinc content |
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|
pH |
6.0 ~ 7.5 |
6.6 |
|
Loss on drying |
≤ 5.0% |
3.0% |
|
Zinc (Dried basis) |
4.0% ~ 6.0% |
5.0% |
|
Bacitracin A |
≥ 40.0% |
72.8% |
|
Sum of bacitracin A、 B1、B2 and B3 |
≥ 70.0% |
91.3% |
|
Limit of early eluting peptides |
≤ 20.0% |
2.8% |
|
Bacitracin F |
≤ 6.0% |
2.5% |
|
Microbial assay (Dried basis) |
≥ 65 IU/mg |
77.5IU/mg |
|
Total viable aerobic count |
≤100 CFU/gram |
Conforms |
|
Particle size |
Min.99.0% ≤ 20.0µm by volume |
99.7% |
|
Conclusion: complies with current USP |
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Storage:Preserve in tight containers and store below 25℃ |
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