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%
113.424536334532244532804524134534644532030.11
213.474543584542184542880.03
单位质量响应值RSD%判断
33770.7233725.910.10数据可信
供试品溶液-24031801-1批-pH6.0(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%
5min140246-402468.8999.458.718.909.448.72
249508-4950810.94710.95
340663-406638.9918.99
444611-446119.8649.86
540171-401718.8838.88
641114-411149.0919.09
10min1146573-14657332.41134.085.4432.5134.185.45
2169156-16915637.40437.53
3150328-15032833.24133.34
4158216-15821634.98535.09
5148453-14845332.82632.92
6152036-15203633.61933.72
15min1235261-23526152.02153.753.4552.4854.233.47
2257321-25732156.89957.44
3238711-23871152.78453.25
4248962-24896255.05155.55
5238518-23851852.74253.21
6239646-23964652.99153.47
20min1293782-29378264.96266.642.3566.0067.722.38
2308759-30875968.27369.44
3298003-29800365.89566.95
4311436-31143668.86569.98
5296719-29671965.61166.66
6299419-29941966.20867.27
30min1365730-36573080.87182.951.9682.6384.781.99
2384262-38426284.96986.90
3376614-37661483.27885.07
4382107-38210784.49286.37
5368454-36845481.47383.25
6373692-37369282.63284.43
45min1413736-41373691.48692.621.1694.1495.371.20
2423228-42322893.58596.46
3416247-41624792.04194.75
4424485-42448593.86396.68
5413908-41390891.52494.21
6421695-42169593.24695.96
60min1410871-41087190.85395.162.2894.5398.932.25
2435326-43532696.260100.17
3431733-43173395.46699.20
4437590-43759096.761100.62
5434213-43421396.01499.71
6432327-43232795.59799.35
极限1428747-42874794.80696.561.1299.49101.391.16
2439000-43900097.073102.05
3436486-43648696.517101.31
4443711-44371198.114103.05
5435629-43562996.327101.09
6436566-43656696.534101.35
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%
113.424525854525294533094530034531034529060.08
213.474521914524604523260.05
单位质量响应值RSD%判断
33748.5833580.250.36数据可信
供试品溶液-24031801-2批-pH6.0(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%
5min136097-360978.0027.3616.268.007.3616.26
241197-411979.1329.13
328886-288866.4036.40
429848-298486.6176.62
535967-359677.9737.97
627214-272146.0336.03
10min1135086-13508629.94529.947.3830.0330.027.40
2146459-14645932.46632.57
3143438-14343831.79731.87
4128873-12887328.56828.64
5137270-13727030.42930.52
6119157-11915726.41426.48
15min1224408-22440849.74649.975.6250.1750.385.63
2237379-23737952.62153.08
3240966-24096653.41653.84
4218472-21847248.43048.82
5225067-22506749.89250.32
6206244-20624445.71946.08
20min1291156-29115664.54264.944.3265.5265.904.35
2302544-30254467.06668.11
3311676-31167669.09170.11
4286517-28651763.51464.44
5290204-29020464.33165.31
6275501-27550161.07261.94
30min1371638-37163882.38382.642.7684.0784.342.80
2378536-37853683.91285.70
3390174-39017486.49288.28
4368696-36869681.73183.37
5366849-36684981.32183.02
6361031-36103180.03181.58
45min1421252-42125293.38193.901.7395.9996.511.76
2423737-42373793.93296.66
3437448-43744896.97199.72
4422942-42294293.75696.30
5416083-41608392.23594.83
6420002-42000293.10495.54
60min1440485-44048597.64498.121.45101.29101.771.45
2440242-44024297.590101.36
3453867-453867100.611104.43
4443809-44380998.381101.97
5434546-43454696.32899.95
6442865-44286598.172101.64
极限1448502-44850299.42299.801.39104.15104.551.37
2445754-44575498.812103.66
3459576-459576101.876106.82
4453419-453419100.511105.19
5441835-44183597.944102.64
6452269-452269100.257104.82
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