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質量報告單
CERTIFICATE OF ANALYSIS
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品 名 Product Name |
非那雄胺（Finasteride） |
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規 格 Specification |
1 kg/Tin |
批 號 Batch No |
20190528 |
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數 量 Quantity |
1kg |
生產日期 MFG. Date |
2019.05.28 |
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檢驗標準 Test Standard |
According to USP37 |
有效日期 Exp Date |
2021.05.28 |
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檢驗項目 Test Items |
檢驗指標 Specification |
檢驗結果 Test Results |
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性狀 Description |
白色或類白色結晶性粉末 White or off-white crystalline powder |
類白色結晶性粉末 Off-white crystalline powder |
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比旋度 Specific rotation |
-56°~-60° |
-58.2° |
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鑒別 Identification |
IR |
Matches with working standard |
Complies |
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HPLC |
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溶解性 Solubility |
Freely soluble in chloroform and in alcohol; Very slightly soluble in water |
Conform |
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重金屬 Heavy metals |
≤10ppm |
＜10ppm |
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水分 Water |
≤0.3% |
0.22% |
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灼燒殘渣 Residue on ignition |
≤0.1% |
0.05% |
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相關物質 Relative material |
最大雜質≤0.5% |
0.36% |
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總雜質≤1.0% |
0.52% |
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含量Assay |
98.5~101.0% |
99.48% |
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結論 Conclusion |
符合USP37 Passed |
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質保部主管（Director）： 復核員(tester)： 化驗員(Retester)：
