奥利司他胶囊项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号520027-202102对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.5对照品水分(%)0对照品稀释倍数200
标示量(mg)60供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.394587024588264586404590834591274588760.05
213.434573124577434575280.07
单位质量响应值RSD%判断
34270.0534067.610.42数据可信
供试品溶液-43023批-pH2.0(内含3%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min132085-320857.0074.3163.287.014.3163.26
223847-238475.2085.21
332830-328307.1707.17
415834-158343.4583.46
513857-138573.0263.03
6-0.0000.00
10min197927-9792721.38818.4922.1621.4018.5022.18
294743-9474320.69220.70
3106176-10617623.18923.20
477459-7745916.91716.92
577299-7729916.88216.89
654444-5444411.89111.89
15min1146947-14694732.09429.4413.1032.1429.4813.12
2143905-14390531.42931.47
3158602-15860234.63934.69
4122613-12261326.77926.81
5124568-12456827.20627.24
6112254-11225424.51724.54
20min1186635-18663540.76238.379.9840.8638.4610.00
2183442-18344240.06440.16
3201619-20161944.03444.14
4160738-16073835.10635.18
5163704-16370435.75335.83
6157942-15794234.49534.56
30min1246321-24632153.79751.816.6153.9751.966.63
2240660-24066052.56152.72
3262614-26261457.35657.54
4223353-22335348.78148.92
5224136-22413648.95249.09
6226123-22612349.38649.50
45min1305411-30541166.70364.544.7466.9664.784.76
2295850-29585064.61464.86
3317598-31759869.36469.64
4283424-28342461.90162.12
5280835-28083561.33561.55
6289954-28995463.32763.53
60min1342461-34246174.79472.604.0175.1672.954.03
2332497-33249772.61872.98
3351988-35198876.87577.27
4319565-31956569.79470.12
5317139-31713969.26469.59
6330807-33080772.24972.56
极限1387028-38702884.52883.301.8385.0283.761.85
2379722-37972282.93283.41
3390981-39098185.39185.91
4381221-38122183.26083.70
5371130-37113081.05681.49
6378315-37831582.62583.05
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