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產(chǎn)品名稱:特比萘芬堿基 Product Name:Terbinafine base |
生產(chǎn)日期:2023.04.05 Manuf.Date: |
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生產(chǎn)批號(hào):230401 Batch No: |
報(bào)告日期: Report Date: |
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報(bào)告單號(hào):230418 COA NO |
復(fù)驗(yàn)期至:2025.04.04 Retest to: |
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檢驗(yàn)標(biāo)準(zhǔn):企業(yè)標(biāo)準(zhǔn) Specification :In-house |
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檢驗(yàn)結(jié)果Analytical Results |
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項(xiàng)目 Item |
檢驗(yàn)標(biāo)準(zhǔn) Acceptance criteria |
結(jié)果 Result |
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性狀 Character |
白色或類白色粉末 White or off-white powder |
白色粉末 White powder |
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水分 water |
≤0.5% |
0.27% |
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有關(guān)物質(zhì) Related substances |
未知單個(gè)雜質(zhì) Unspecified impurity ≤0.1% 總雜質(zhì) Total impurities≤1.0% |
0.02%
0.09% |
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殘留溶劑 Residual solvents |
甲醇Methanol≤3000ppm 氯仿chloroform≤600ppm 乙酸乙酯 ethyl acetate≤5000ppm |
139ppm 52ppm 5ppm |
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純度 Purity |
≥99.0% |
99.91% |