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环孢素A,59865-13-3,质检单
分析证明书
CERTIFICATE OF ANALYSIS
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产品名称PRODUCT NAME：环孢素CYCLOSPORINE A |
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产品批号BATCH NO. |
202310910 |
生产日期MFG. DATE |
2023.09.10 |
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数量QUANTITY |
250G |
有效期EXP DATE |
2026.09.09 |
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检验项目 Inspection Item |
标准规定 Specification |
检验结果 Results |
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鉴别Identification |
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高效液相色谱（HPLC） |
应符合规定Conform the requirement |
Conform |
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检查Test |
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有关物质Related substances |
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单个杂质 Individual impurity |
≤0.7% |
0.35%
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杂质总和 Total impurity |
≤1.5% |
0.96% |
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干燥失重Loss on drying |
≤2.0% |
0.87% |
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含量测定Assay |
98.5—101.5% |
98.6% |
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微生物限度 Microbial limit |
需氧菌总数≤1000cfu/g Total aerobic bacteria NMT 1000cfu/g
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10cfu/g
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霉菌和酵母菌总数≤100cfu/g Total yeast and mold NMT 100cfu/g |
5cfu/g
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结论：此产品符合美国药典42标准. Conclusion : THE PRODUCT CONFORM TO USP42. |
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