奥利司他胶囊项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
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)120供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.574569344573974570084564754571484569920.08
213.494540394524384532380.25
单位质量响应值RSD%判断
33676.6433598.070.17数据可信
供试品溶液-24052201-1批-pH6.8(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%
5min144005-440059.76312.1122.489.7612.1122.48
247503-4750310.53910.54
351206-5120611.36011.36
445155-4515510.01810.02
566146-6614614.67514.67
673465-7346516.29816.30
10min1180815-18081540.11437.656.7440.2237.796.68
2186775-18677541.43641.55
3163224-16322436.21236.34
4157660-15766034.97735.09
5163191-16319136.20436.37
6166670-16667036.97637.16
15min1243766-24376654.08053.901.4254.6354.451.43
2238214-23821452.84853.43
3242845-24284553.87654.40
4239802-23980253.20153.70
5246657-24665754.72155.29
6246426-24642654.67055.26
20min1304632-30463267.58367.370.9768.7468.530.99
2303516-30351667.33668.50
3299164-29916466.37067.50
4302540-30254067.11968.21
5304142-30414267.47468.65
6308125-30812568.35869.56
30min1381540-38154084.64582.961.5186.5584.851.50
2378415-37841583.95285.86
3366003-36600381.19883.06
4370402-37040282.17484.01
5372003-37200382.53084.45
6375187-37518783.23685.19
45min1413028-41302891.63192.081.4794.4894.901.45
2423466-42346693.94796.79
3405207-40520789.89692.66
4418241-41824192.78895.54
5414022-41402291.85294.69
6416441-41644192.38895.27
60min1427242-42724294.78494.531.1898.6598.381.17
2433482-43348296.169100.06
3422607-42260793.75697.52
4424741-42474194.23098.01
5419330-41933093.02996.89
6429149-42914995.20899.12
极限1427205-42720594.77695.121.2599.69100.011.24
2438481-43848197.278102.24
3423875-42387594.03798.84
4424990-42499094.28599.11
5427059-42705994.74499.64
6430822-43082295.579100.55
奥利司他胶囊项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
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)120供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.574532684534034530414535504529174532360.06
213.494522914516154519530.11
单位质量响应值RSD%判断
33399.8533502.820.22数据可信
供试品溶液-24052201-2批-pH6.8(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%
5min150742-5074211.32012.587.6911.3212.587.68
260174-6017413.42413.42
355570-5557012.39712.40
453884-5388412.02112.02
555286-5528612.33412.33
662674-6267413.98213.98
10min1158796-15879635.42536.266.9835.5536.406.97
2172445-17244538.47038.62
3166371-16637137.11537.25
4142867-14286731.87232.01
5160982-16098235.91336.05
6173807-17380738.77438.93
15min1240821-24082153.72454.714.9654.2455.254.98
2255002-25500256.88757.46
3251907-25190756.19756.75
4224653-22465350.11750.60
5241811-24181153.94554.48
6257200-25720057.37857.96
20min1299044-29904466.71267.653.7567.8368.803.78
2311132-31113269.40970.62
3311064-31106469.39470.57
4284327-28432763.42964.47
5299220-29922066.75267.89
6314618-31461870.18771.41
30min1370903-37090382.74383.362.3284.6085.262.37
2379829-37982984.73486.71
3380900-38090084.97386.92
4360299-36029980.37882.13
5368270-36827082.15684.03
6381918-38191885.20087.20
45min1416478-41647892.91093.181.2295.6996.001.30
2420222-42022293.74696.67
3422436-42243694.23997.13
4411060-41106091.70294.34
5412677-41267792.06294.85
6423171-42317194.40397.35
60min1430879-43087996.12395.910.7599.9399.770.83
2431046-43104696.160100.12
3432812-43281296.554100.49
4426445-42644595.13498.80
5425430-42543094.90798.72
6432878-43287896.569100.57
极限1439996-43999698.15796.790.92103.03101.720.90
2434175-43417596.858101.89
3434684-43468496.972101.98
4432785-43278596.548101.27
5427654-42765495.404100.27
6433878-43387896.792101.86
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