Polymyxin B sulfate is a multi-skin antibiotic drug, which has the characteristics of low cost, good market potential and broad prospect.
Polymyxin B is produced by a group of skin antibiotics, commonly used its sulfate, called sulfate polymyxin B or colistin B sulfate, for anti-gram-negative bacteria skin antibiotics, mainly used for the treatment of gram-negative bacteria infection, in addition to proteus, it has bactericidal effect on almost all gram-negative bacilli.
It is mainly used in four directions: first, non-sterile powder for compound polymyxin B sulfate paste for burns, burns and cuts; second, sterile non-injection material for polymyxin B sulfate eye drops for ophthalmic drugs; third, sterile powder is applied to polymyxin B sulfate preparation for injection; fourth, the synthesis of anti-superbacteria drug, which solves the toxic side effects for injection, which is the future development direction and is the "ultimate killer" of superbacteria among the known drugs at present.
Molecular formula, molecular weight：
Chinese Name：硫酸多粘菌素B
English Name：Polymyxin B sulfate
chemical structural formula：
Product Parameter：
Product name:Polymyxin B Sulfate(Non-sterile) 产品名称:多粘菌素B硫酸盐(非无菌) | ||
Batch No:20230201 批次号：20230201 | Packing:3.0kg/tin 包装：3.0千克/听 | Report Date: Feb. 17,2023 报告日期：2023年2月17日 |
Batch Size:3.20kg 批次重量：3.2千克 | No. of Package:2 包装数量：2 | M.f.G Date: Jan.10,2023 生产日期：2023年1月10日 |
According to: USP42 and In-house specification 检验依据：USP42和内部规范 | Retest Date: Jan .09,2025 复检日期：2025年1月9日 | |
| Test items 检验项目 | Specification 说明及参考值 | Test results 检验结果 |
Appearance 性状 | Whitetobuff-coloredpowder.ls odorless or has afaint odor 白色到浅黄色的粉末，无气味或有淡淡的气味 | White powder. Odorless 白色粉末。没有气味的 |
ldentification 验证 | HPLC 高新能液体色谱 | Conforms 相一致 |
Color reaction with cupric sulfate solution 与硫酸铜溶液的着色反应 | Conforms 相一致 | |
Sulfate reaction 硫酸盐反应 | Conforms 相一致 | |
| PH 酸碱度 | 5.0-7.5(5mg/ml) | 6.0 |
| Loss on drying 干燥失重 | ≤7.0% | 2.7% |
| Sulphated Ash 硫酸灰分 | NMT 0.75% | 0.15% |
Microbiological examination 微生物学检验 | TAMC:≤ 10 cfu/g | Conforms 相一致 |
| TYMC:≤ 10 cfu/g | Conforms 相一致 | |
Staphylococcus aureus:undetected 金黄色葡萄球菌：未检测到 | Conforms 相一致 | |
| 化验 Assay | ≥6000u/mg(Anhydrous) ≥6000u/mg (无水的) | 7992U/mg |
Related substance 有关物质 | Any impurity:≤3.0% 任意杂志：≤3.0% | 2.1% |
Total impurities: ≤17.0% 总杂质：≤17.0% | 10.9% | |
| Purity-sum 纯度和 | NLT 80.0% | 90.2% |
| Purity-B3 B3纯度 | Max 6.0% 最大 6.0% | 1.3% |
| Purity-B1-l B1-l纯度 | Max 15.0% 最大 15.0% | 7.2% |
Storage: Preserve in tight, light-resistant containers 储存：保存在紧密的、耐光的容器中。 CONCLUSION: This product conforms with USP42 and In-house specification 结论：本产品符合USP42和内部规范。 | ||
Category：PRODUCTS Time：2023-12-25 110Browse
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