倍他米松戊酸酯2152-44-5,哪里有优质的倍他米松戊酸酯原料
检 验 报 告 单
CERTIFICATE OF ANALYSIS
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品 名 PRODUCT NAME |
倍他米松戊酸酯 Betamethasone Valerate
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来源地 SOURCE |
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批 号 BATCH NUMBER |
20191002 |
生产日期 MANUFACTURE DATE |
2019.10.18 |
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重 量 QUANTITY |
100KG |
有效期至 EXPIRY DATE |
2022.10.17 |
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检测标准 STANDARDS |
USP38 Be conform with USP38 |
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检验项目/TEST ITEMS |
标准/ SPECIFICATIONS |
结果/RESULTS |
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外观 Appearance |
白色或类白色结晶性粉末 White or almost white, crystalline powder |
符合 Conform |
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鉴别 |
A:IR |
应与对照品图谱一致 The spectrum should be accord to the betamethasone valerate CRS |
符合 Conform |
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B:TLC |
应符合规定 Conform |
符合 Conform |
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比旋度 Specific Optical Rotation |
+75°~+82°（以干品计） +75°~+82°（dried substance） |
+77º |
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有关物质 Related substances |
最大单杂 ≤1.0% Maximum any imputity ≤1.0%
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0.22% |
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总 杂≤ 2.0% Total impurities ≤ 2.0%
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0.31% |
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干燥失重 Loss on drying |
≤ 0.5% |
0.1% |
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炽灼残渣 Residue on Ignition |
≤0.2% |
0.02% |
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含量 Content |
含C27H37FO6应为97.0%~ 103.0%(以干品计） 97.0 percent to 103.0 percent (dried substance). |
98.1% |
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结论 Conclusion |
符合 USP38 Be conform with USP38 |
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