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品 名
Product Name
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硝酸咪康唑
Econazole Nitrate
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批 號
Batch No
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20191008
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數 量
Quantity
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200kgs
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包 裝
Packing
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25kgs/紙板桶
25kgs/drum
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生產日期
MFG. Date
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2019.10.08
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有 效 期
Exp Date
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2021.10.07
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檢驗項目
Test Items
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檢驗指標
Specification
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檢驗結果
Test Results
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外觀Appearance
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白色或類白色結晶粉末
White or Almost white powder
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符合規定
Complies
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鑒別
Identification
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紅外光譜吸收
IR
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與標準相近Similar to standard
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符合規定
Complies
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溶液澄清度
Appearance of Solution
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溶液清澈，色澤不深于標準液
The solution is clear and not more intensely cloured than reference solutions
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符合規定
Complies
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溶解性Solubility
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難溶于水，溶于甲醇，微溶于乙醇
Very slightly soluble in water; soluble in methanol ; slightly soluble in alcohol
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符合規定
Complies
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旋光度
Angle of optical rotation
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-0.1o～+0.1o
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符合規定
Complies
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相關物質(HPLC) Related Substances
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單個雜質
Each Impurity
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≤0.25%
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0.18%
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雜質總和
Total Impurity
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≤0.5%
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0.25%
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熔點Melting Point
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163～167℃
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164.5℃
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干燥失重Loss on Drying
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≤0.5%（105℃2小時）
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0.32%
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熾灼殘渣Residue on Ignition
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≤0.1%
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0.01%
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含量（干基）Assay (on dry basis)
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98.0～102.0%
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99.38%
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結論
Conclusion
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本品符合USP35/BP2007標準
Conform to the specification of USP35/BP2007
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