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質(zhì)量報(bào)告單
CERTIFICATE OF ANALYSIS
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品 名 Product Name |
吡羅昔康36322-90-4 Piroxicam |
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數(shù) 量 Quantity |
75KGS |
批 號 Batch No |
20200512 |
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生產(chǎn)日期 MFG. Date |
May 17, 2020 |
有效日期 Expiry Date |
May 16, 2024 |
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規(guī)格 SPECIFICATIONS |
按美國藥典35版標(biāo)準(zhǔn) STANDARD USP35 |
檢驗(yàn)結(jié)果 Test Results |
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Characteristics 性狀 |
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 鑒別 |
POSITIVE 正反應(yīng) |
COMPLIES |
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Residue on ingition 熾灼殘?jiān)?/p> |
≤0.3% |
0.08% |
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Heavy metals 重金屬 |
≤0.002% |
0.0004% |
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Water 水份 |
≤0.5% |
0.15% |
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有機(jī)揮發(fā)性雜質(zhì)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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結(jié)論 Conclusion |
THE PRODUCT CONFORMS TO U.S.P.35 本品符合U.S.P.35版規(guī)定 |
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