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質(zhì)量報(bào)告單
CERTIFICATE OF ANALYSIS
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品 名 Product Name |
非那雄胺（Finasteride） |
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規(guī) 格 Specification |
1 kg/Tin |
批 號(hào) Batch No |
20190528 |
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數(shù) 量 Quantity |
1kg |
生產(chǎn)日期 MFG. Date |
2019.05.28 |
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檢驗(yàn)標(biāo)準(zhǔn) Test Standard |
According to USP37 |
有效日期 Exp Date |
2021.05.28 |
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檢驗(yàn)項(xiàng)目 Test Items |
檢驗(yàn)指標(biāo) Specification |
檢驗(yàn)結(jié)果 Test Results |
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性狀 Description |
白色或類白色結(jié)晶性粉末 White or off-white crystalline powder |
類白色結(jié)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?jiān)?/p> Residue on ignition |
≤0.1% |
0.05% |
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相關(guān)物質(zhì) Relative material |
最大雜質(zhì)≤0.5% |
0.36% |
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總雜質(zhì)≤1.0% |
0.52% |
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含量Assay |
98.5~101.0% |
99.48% |
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結(jié)論 Conclusion |
符合USP37 Passed |
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質(zhì)保部主管（Director）： 復(fù)核員(tester)： 化驗(yàn)員(Retester)：
