吡罗昔康Piroxicam东康源现货质检单
质量报告单
CERTIFICATE OF ANALYSIS
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品 名 Product Name |
吡罗昔康36322-90-4 Piroxicam |
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数 量 Quantity |
75KGS |
批 号 Batch No |
20200512 |
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生产日期 MFG. Date |
May 17, 2020 |
有效日期 Expiry Date |
May 16, 2024 |
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规格 SPECIFICATIONS |
按美国药典35版标准 STANDARD USP35 |
检验结果 Test Results |
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Characteristics 性状 |
A white or slightly yellow,crystalline powder |
CMPLIES |
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Solubility 溶解度 |
Practically insoluble in water,soluble in Methylene chloride,slightly soluble in ethanlo |
COMPLIES |
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IDENTIFICATION 鉴别 |
POSITIVE 正反应 |
COMPLIES |
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Residue on ingition 炽灼残渣 |
≤0.3% |
0.08% |
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Heavy metals 重金属 |
≤0.002% |
0.0004% |
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Water 水份 |
≤0.5% |
0.15% |
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有机挥发性杂质Organic volatile impurities |
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METTYLENE CHLORIDE |
＜500PPM |
＜500PPM |
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CHLOROFORM |
＜50PPM |
＜50PPM |
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TRICHLOROETHYLENE |
＜80PPM |
＜80PPM |
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1,4-—DIOXANE |
＜100PPM |
＜100PPM |
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BENZENE |
＜2PPM |
＜2PPM |
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含量Assay(Calculated on dried basis) |
97.0-103.0% |
99.47% |
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结论 Conclusion |
THE PRODUCT CONFORMS TO U.S.P.35 本品符合U.S.P.35版规定 |
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