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分 析 报 告 单
REPORT FOR DETECTING AND ANALYSIS
生产日期:2022.11.16 有效日期:2024.11.15
品 名 Product Name |
保 泰 松 Phenyl Butazone |
批号 Batch NO |
20221106 |
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总量 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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作用与用途 Action and Use |
消炎止痛 Anti-inflammatory;Analgesic |
检验结果 Results |
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性状 Characters |
白色或类白色结晶性粉末,几乎不溶于水,溶于乙醚微溶于乙醇,本品在氢氧化钠溶液中溶解。 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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鉴别 Identification |
A.熔点 Melting Point |
104~107℃ |
104~107℃ |
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B.吸收系数 Specific Absorbance |
Complies |
Complies |
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C.红外光吸收图谱 IR Absorption Spwctrophotometry |
与对照品一致 Comparing with Spectrum obtained with phenylbutazone CRS |
Complies |
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D.与亚硝酸钠反应 Reaction with NaNo. |
+ |
Complies |
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检查 Tests |
溶液的外观 Apearance of solution |
澄清 Solution is Clear |
Complies |
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酸碱值 Acidity or Alkalinity |
符合 Pass test |
Complies |
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吸收值 Absorbance |
﹤0.2 |
0.14 |
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有关杂质 Related Substance |
符合 Pass test |
Complies |
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重金属 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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硫酸盐 Sulfate |
﹤0.01% |
0.006% |
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有机挥发性物质 Organic Volatile Impurities |
﹤0.002% |
Complies |
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含量 Assay |
99.0~101.0% |
99.9% |
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符合英国药典2000版 美国药典25版 Complies with B.P2000Ed Complies with U.S.P25Ed |
Date of manufacture: Nov.16, 2022 Expiry Date: Nov.15, 2024