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T12B-A020-230703对照品来源自制对照品使用方法直接使用
对照品含量(%)100.4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%
113.354510904512044511984508544511474510990.04
213.43 4521344519794520560.03
单位质量响应值RSD%判断
33790.1933660.160.28数据可信
供试品溶液-23120501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%
5min144897-4489710.0249.4113.6310.029.4113.63
249052-4905210.95210.95
335825-358257.9998.00
438477-384778.5918.59
547647-4764710.63810.64
637040-370408.2708.27
10min1129176-12917628.84229.247.4828.9529.357.44
2137102-13710230.61230.73
3143667-14366732.07732.17
4135966-13596630.35830.45
5117696-11769626.27926.40
6122221-12222127.28927.38
15min1203740-20374045.49046.245.2245.9246.675.21
2215694-21569448.15948.62
3220108-22010849.14549.59
4212470-21247047.43947.87
5191969-19196942.86243.27
6198699-19869944.36544.76
20min1264515-26451559.06059.514.0860.0060.464.09
2274467-27446761.28262.28
3280583-28058362.64763.64
4270319-27031960.35661.32
5250869-25086956.01356.90
6258459-25845957.70858.60
30min1329028-32902873.46475.292.8875.0676.902.91
2345351-34535177.10978.79
3348753-34875377.86879.56
4343022-34302276.58978.22
5325326-32532672.63874.15
6331776-33177674.07875.61
45min1390266-39026687.13787.361.6689.5589.801.72
2394277-39427788.03390.57
3398494-39849488.97491.53
4396119-39611988.44490.93
5380708-38070885.00387.32
6387782-38778286.58288.93
60min1415887-41588792.85893.141.4696.2496.551.52
2422569-42256994.35097.86
3422225-42222594.27397.81
4420445-42044593.87597.34
5406550-40655090.77394.03
6415209-41520992.70696.02
极限1424225-42422594.71995.981.4599.13100.421.49
2432825-43282596.640101.20
3437084-43708497.590102.18
4432990-43299096.676101.18
5420455-42045593.87898.15
6431520-43152096.348100.69
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T12B-A020-230703对照品来源自制对照品使用方法直接使用
对照品含量(%)100.4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%
113.354518334515434516534513314515414515800.05
213.43 4506884509874508380.05
单位质量响应值RSD%判断
33826.2233569.470.54数据可信
供试品溶液-23120601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%
5min129547-295476.6036.2013.916.606.2013.94
230607-306076.8396.84
328243-282436.3116.31
420651-206514.6154.61
526392-263925.8985.90
631005-310056.9286.93
10min1105693-10569323.61823.506.2923.6923.576.32
2111562-11156224.93025.01
3109264-10926424.41624.49
492766-9276620.72920.78
5104142-10414223.27223.34
6107559-10755924.03524.11
15min1177757-17775739.72240.074.3740.0640.404.39
2188064-18806442.02542.38
3184140-18414041.14841.49
4165157-16515736.90637.19
5181104-18110440.46940.79
6179660-17966040.14740.49
20min1236784-23678452.91253.112.6653.6953.882.69
2241792-24179254.03154.85
3246437-24643755.06955.87
4227557-22755750.85051.54
5236928-23692852.94453.72
6236466-23646652.84153.63
30min1304155-30415567.96670.262.6769.3371.622.68
2321506-32150671.84473.26
3324539-32453972.52173.93
4305589-30558968.28769.54
5317946-31794671.04872.41
6312839-31283969.90771.28
45min1379262-37926284.75084.651.5186.8786.801.53
2378363-37836384.54986.77
3383987-38398785.80688.02
4369561-36956182.58284.60
5385379-38537986.11788.27
6376370-37637084.10486.26
60min1405064-40506490.51591.371.2393.5894.461.21
2403158-40315890.09093.25
3415633-41563392.87796.05
4409098-40909891.41794.35
5414039-41403992.52195.63
6406275-40627590.78693.87
极限1427385-42738595.50395.561.6599.5799.661.63
2432444-43244496.634100.79
3423231-42323194.57598.78
4417204-41720493.22897.18
5437360-43736097.732101.87
6428180-42818095.68199.78
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T12B-A020-230703对照品来源自制对照品使用方法直接使用
对照品含量(%)100.4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%
113.354511694512184510044506234510514510130.06
213.43 4499234496394497810.05
单位质量响应值RSD%判断
33783.7533490.770.62数据可信
供试品溶液-23120602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%
5min132583-325837.2946.3712.207.296.3712.21
231596-315967.0737.07
330474-304746.8226.82
425969-259695.8145.81
525434-254345.6945.69
624719-247195.5345.53
10min1118669-11866926.56625.184.6326.6525.254.66
2117262-11726226.25126.33
3114984-11498425.74125.82
4110029-11002924.63124.70
5107681-10768124.10624.17
6106230-10623023.78123.84
15min1204778-20477845.84243.163.7746.2243.503.78
2197411-19741144.19344.56
3190960-19096042.74943.11
4191544-19154442.88043.22
5186230-18623041.69042.02
6185732-18573241.57941.90
20min1268210-26821060.04257.243.1860.9358.073.20
2260853-26085358.39559.26
3254877-25487757.05857.89
4255791-25579157.26258.08
5247763-24776355.46556.26
6246649-24664955.21656.00
30min1345547-34554777.35574.962.4778.9176.432.49
2341706-34170676.49578.01
3332097-33209774.34475.82
4335729-33572975.15776.61
5331965-33196574.31575.73
6322130-32213072.11373.51
45min1408125-40812591.36488.901.8193.7891.201.85
2402444-40244490.09292.45
3395730-39573088.58990.89
4394021-39402188.20790.49
5394972-39497288.42090.66
6387490-38749086.74588.95
60min1426787-42678795.54293.811.3198.9797.101.31
2417821-41782193.53596.90
3412802-41280292.41195.69
4416509-41650993.24196.51
5424660-42466095.06698.28
6415811-41581193.08596.25
极限1439841-43984198.46497.061.38102.95101.391.39
2436001-43600197.605102.00
3430614-43061496.399100.71
4427590-42759095.722100.02
5440401-44040198.590102.86
6427052-42705295.60199.80
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