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質(zhì)檢報(bào)告單——CERTIFICATE OF ANALYSIS |
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產(chǎn)品名稱 Product Name |
碘海醇-USP Iohexol |
產(chǎn)品批號(hào) Batch No. |
230513 |
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批次數(shù)量 Quantity |
1016.7KG |
生產(chǎn)日期 Man. Date |
2023-05-16 |
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包裝規(guī)格 Packaging |
25KG/紙桶/Drum |
檢測(cè)日期 Test Date |
2023-05-24 |
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有效日期 Expiry Date |
2025-05-15 |
報(bào)告日期 Report Date |
2023-05-25 |
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檢驗(yàn)項(xiàng)目 Test Items |
檢驗(yàn)指標(biāo) Standard |
檢驗(yàn)結(jié)果 Test Results |
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性狀 Characteristics |
為白色至類白色結(jié)晶性粉末 White to off white crystalline powder |
符合規(guī)定 Complies |
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溶解性 Solubility |
符合規(guī)定 Complies |
符合規(guī)定 Complies |
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鑒別 Identification |
IR、HPLC 符合規(guī)定 Complies |
符合規(guī)定 Complies |
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溶液 Solution |
≤Y7 |
＜Y7 |
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溶液吸光度 Solution of Absorption |
≤0.180 ≤0.030 ≤0.015 |
400nm 420nm 450nm |
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0.179 0.023 0.011 |
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游離碘 Free iodide |
≤0.001% |
＜0.001% |
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離子化合物 lonic compounds |
≤0.01% |
＜0.01% |
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游離芳香胺 Free aromatic amine |
≤0.05% |
＜0.005% |
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