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REPORT FOR DETECTING AND ANALYSIS
生產(chǎn)日期：2022.11.16 有效日期：2024.11.15
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品 名 Product Name |
保 泰 松 Phenyl Butazone |
批號 Batch NO |
20221106 |
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總量 Total Quantity |
500kg |
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分子式及分子量 Molecular Formula and Molecular Weight |
C19H20N2O2 308.38 |
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作用與用途 Action and Use |
消炎止痛 Anti-inflammatory;Analgesic |
檢驗結(jié)果 Results |
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性狀 Characters |
白色或類白色結(jié)晶性粉末，幾乎不溶于水，溶于乙醚微溶于乙醇，本品在氫氧化鈉溶液中溶解。 A White or Almost White,Crystalline Powder,Practically insoluble in water,soluble in ether,sparingly soluble in alcohol,It dissolver in alkaline solution |
Complies |
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鑒別 Identification |
A.熔點 Melting Point |
104~107℃ |
104~107℃ |
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B.吸收系數(shù) Specific Absorbance |
Complies |
Complies |
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C.紅外光吸收圖譜 IR Absorption Spwctrophotometry |
與對照品一致 Comparing with Spectrum obtained with phenylbutazone CRS |
Complies |
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D.與亞硝酸鈉反應(yīng) Reaction with NaNo. |
+ |
Complies |
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檢查 Tests |
溶液的外觀 Apearance of solution |
澄清 Solution is Clear |
Complies |
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酸堿值 Acidity or Alkalinity |
符合 Pass test |
Complies |
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吸收值 Absorbance |
﹤0.2 |
0.14 |
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有關(guān)雜質(zhì) Related Substance |
符合 Pass test |
Complies |
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重金屬 Heavy metals |
﹤10PPM |
﹤10PPM |
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干燥失重 Loss on drying |
﹤0.2% |
0.12% |
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磺化灰份 Sulohated ash |
﹤0.1% |
0.08% |
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氯化物 Chloride |
﹤0.007% |
0.005% |
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硫酸鹽 Sulfate |
﹤0.01% |
0.006% |
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有機(jī)揮發(fā)性物質(zhì) Organic Volatile Impurities |
﹤0.002% |
Complies |
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含量 Assay |
99.0~101.0% |
99.9% |
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符合英國藥典2000版 美國藥典25版 Complies with B.P2000Ed Complies with U.S.P25Ed |
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Date of manufacture: Nov.16, 2022 Expiry Date: Nov.15, 2024
