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Certificate of Analysis
Product Name: Bacitracin USP
Batch No.: 211115 Batch Size: 41.46KG
Mfg.Date: 2021.11.30 Report Date: 2021.12.05
Retest Date: 2023.11.29
|
Tests |
Specifications |
Results |
|
Appearance |
White to pale buff powder |
White powder |
|
Identification |
TLC,Conforms |
Conforms |
|
HPLC,Conforms |
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|
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 |
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|
Storage:Preserve in light containers and store below 8℃. |
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