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Certificate of Analysis
产品检验报告单 PROFILE NO.：2023.08.14
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Product name |
Ivermectin |
Inspect Date 检验日期 |
14th,Aug,2023 |
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品 名 |
伊维菌素 |
2023年8月14日 |
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Batch NO. |
20230814 |
Report date 报告日期 |
14th,Aug,2023 |
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批 号 |
2023年8月14日 |
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Inspect as |
EP8 |
Retest Date 复检日期 |
13th,Aug,2025 |
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检验依据 |
2025年8月13日 |
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Inspect item |
Inspect standard |
Inspect conclusion |
Conclusion |
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检验项目 |
检 验 标 准 |
检 验 结 果 |
单项结论 |
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Characters 性 状 |
Should be white or yellowish-crystalline powder 应为白色或微黄色结晶性粉末 |
White-crystalline powder 白色结晶性粉末 |
符合规定 |
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IR 红外线 |
Should be corresponds with that of CRS standard 应与CRS标准品的图谱一致 |
Corresponds with that of CRS standard 与CRS标准品的图谱一致 |
Conform 符合规定 |
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HPLC 液相鉴别 |
Should be corresponds with retention time of CRS standard 应与标准品保留时间一致 |
Corresponds with that of CRS standard 与标准品一致 |
Conform 符合规定 |
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Specific rotation 比旋度 |
-17º~-20º |
-18.2º |
Conform 符合规定 |
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Water 水分 |
≤1.0% |
0.5% |
Conform 符合规定 |
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Appearance of solution 溶液外观 |
Should be clear and not more intensely colored than BY7 应澄清，溶液颜色不深于BY7 |
Clear 澄清 |
Conform 符合规定 |
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H2B1a/(H2B1a+H2B1b) H2B1a |
≥90.0% |
97.5% |
Conform 符合规定 |
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Related substances 相关物质
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Individual impurities(RRT1.3-1.5)≤2.5% 单一杂质（RRT1.3-1.5）≤2.5% |
2.2% |
Conform 符合规定 |
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Any other individual impurities ≤1% 其他单一杂质≤1% |
0.65% 0.23% 0.49% 0.14% 0.46% 0.20% |
Conform 符合规定 |
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Total impurities ≤5% 杂质总和≤5% |
4.5 |
Conform 符合规定 |
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Disregard limit ≤0.05% 检测限≤0.05% |
0.05% |
Conform 符合规定 |
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Ethanol 乙醇 |
≤5.0% |
3.9 |
Conform 符合规定 |
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Heavy metal 重金属 |
≤0.002% |
＜0.001% |
Conform 符合规定 |
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Formamide 甲酰胺 |
≤3.0% |
2.7% |
Conform 符合规定 |
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Sulphated ash 硫酸灰分 |
≤0.1% |
0.05% |
Conform 符合规定 |
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Assay 含量 |
Should be 95.0%-102.0% 应为95.0%-102.0% |
95.9% |
Conform 符合规定 |
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The conclusion: This product conform the standard requirement of EP8 standard. 结论：经检验，本品符合EP8标准的规定 |
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Inspector:Fan Re-Inspector:Liang QC Responsible：Yang
