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CERTIFICATE OF ANALYSIS
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產(chǎn)品名稱 Product Name |
Raloxifene HCl |
CAS |
82640-04-8 |
|
批號 Batch No. |
22050901 |
生產(chǎn)日期 Producing Date |
2022-05-09 |
|
數(shù)量 Quantity |
50kg |
復測期 Retest Date |
2024-05-08 |
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項目 Items |
標準 Standard |
結(jié)論 Results |
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|
外觀 Appearance |
類白色或淺黃色粉末 Almost white or pale-yellowish powder |
符合 Comply |
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鑒別 Identification |
IR |
符合 Comply |
|
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氯化物 It meets the requirements of the test for Choride |
符合 Comply |
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溶解性 Solubility |
溶于10%的氫氧化鈉溶液，略溶于甲醇，不溶于水 Soluble in 10% sodium hydroxide solution, slightly soluble in methanol, insoluble in water |
符合 Comply |
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|
有關(guān)物質(zhì) Related Substances |
有關(guān)物質(zhì)I≤0.2% ImpurityⅠ≤0.20% |
≤0.2% |
0.18% |
|
其它單個雜質(zhì) Other single impurity |
≤0.1% |
0.06% |
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總雜質(zhì) Total impurities |
≤0.5% |
0.38% |
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干燥失重 Loss on drying |
≤0.5% |
0.20% |
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灼燒殘渣 Residue on ignition |
≤0.1% |
0.04% |
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重金屬 Heavy metals |
≤10ppm |
符合 Comply |
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有機殘留 Residual solvents |
甲醇≤ 3000ppm |
符合 Comply |
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二氯甲烷≤600ppm |
符合 Comply |
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|
含量 Assay |
97.5%～102.0% |
99.2% |
|
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結(jié)論 Determination |
符合USP40標準 Complies with USP40 standard |
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