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環(huán)孢素A,59865-13-3,質(zhì)檢單
分析證明書
CERTIFICATE OF ANALYSIS
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產(chǎn)品名稱PRODUCT NAME：環(huán)孢素CYCLOSPORINE A |
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產(chǎn)品批號BATCH NO. |
202310910 |
生產(chǎn)日期MFG. DATE |
2023.09.10 |
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數(shù)量QUANTITY |
250G |
有效期EXP DATE |
2026.09.09 |
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檢驗項目 Inspection Item |
標準規(guī)定 Specification |
檢驗結果 Results |
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鑒別Identification |
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高效液相色譜（HPLC） |
應符合規(guī)定Conform the requirement |
Conform |
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檢查Test |
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有關物質(zhì)Related substances |
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單個雜質(zhì) Individual impurity |
≤0.7% |
0.35%
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雜質(zhì)總和 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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含量測定Assay |
98.5—101.5% |
98.6% |
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微生物限度 Microbial limit |
需氧菌總數(shù)≤1000cfu/g Total aerobic bacteria NMT 1000cfu/g
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10cfu/g
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霉菌和酵母菌總數(shù)≤100cfu/g Total yeast and mold NMT 100cfu/g |
5cfu/g
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結論：此產(chǎn)品符合美國藥典42標準. Conclusion : THE PRODUCT CONFORM TO USP42. |
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