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%
113.474497124494584489054488524481054490060.14
213.494493954491084492520.05
单位质量响应值RSD%判断
33333.7833302.590.07数据可信
供试品溶液-2024102321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%
5min160128-6012813.46713.7715.4613.4713.7715.47
263276-6327614.17214.17
364516-6451614.45014.45
443417-434179.7249.72
567484-6748415.11515.11
670136-7013615.70915.71
10min1154458-15445834.59534.607.2734.6234.627.27
2163325-16332536.58136.60
3163398-16339836.59736.62
4132939-13293929.77529.79
5155913-15591334.92134.95
6156906-15690635.14335.17
15min1219478-21947849.15849.395.4849.2449.475.49
2232937-23293752.17252.26
3230718-23071851.67551.76
4198863-19886344.54144.61
5219776-21977649.22549.31
6221303-22130349.56749.65
20min1265744-26574459.52060.184.6659.6860.354.67
2283089-28308963.40563.58
3278982-27898262.48662.66
4247504-24750455.43555.58
5265932-26593259.56359.73
6270947-27094760.68660.85
30min1325344-32534472.87074.103.7473.1374.363.74
2347727-34772777.88378.16
3341143-34114376.40876.68
4313263-31326370.16470.40
5325382-32538272.87873.14
6332221-33222174.41074.68
45min1373668-37366883.69385.413.0684.0885.803.06
2397781-39778189.09489.50
3392166-39216687.83688.24
4367345-36734582.27782.63
5375349-37534984.06984.46
6381804-38180485.51585.91
60min1399116-39911689.39391.372.5189.9191.902.52
2422283-42228394.58295.14
3417952-41795293.61294.16
4400205-40020589.63790.12
5399202-39920289.41289.94
6408805-40880591.56392.10
极限1425769-42576995.36297.621.7396.0398.301.74
2445944-44594499.881100.59
3441337-44133798.84999.55
4430797-43079796.48997.12
5439143-43914398.35899.03
6432173-43217396.79797.48
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%
113.474491624491154491974491514484014490050.08
213.494500704511194505940.17
单位质量响应值RSD%判断
33333.7033402.080.15数据可信
供试品溶液-2024102321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%
5min157722-5772212.90914.079.5112.9114.079.51
262790-6279014.04314.04
368752-6875215.37615.38
471459-7145915.98115.98
556909-5690912.72712.73
659930-5993013.40313.40
10min1152495-15249534.10435.513.6034.1335.533.59
2157859-15785935.30435.33
3166416-16641637.21837.24
4163374-16337436.53836.56
5152390-15239034.08134.10
6160142-16014235.81535.84
15min1222167-22216749.68651.272.6649.7651.352.67
2227937-22793750.97751.06
3237477-23747753.11053.20
4233290-23329052.17452.26
5222702-22270249.80649.88
6231887-23188751.86051.94
20min1274346-27434661.35662.972.1361.5263.132.13
2278458-27845862.27562.44
3288700-28870064.56664.74
4286045-28604563.97264.15
5276095-27609561.74761.91
6285613-28561363.87564.04
30min1342216-34221676.53478.101.9376.8078.381.93
2344768-34476877.10577.38
3353722-35372279.10879.39
4358700-35870080.22180.50
5343286-34328676.77477.04
6352619-35261978.86179.14
45min1396942-39694288.77389.551.2489.1689.951.24
2396282-39628288.62689.03
3401761-40176189.85190.27
4408101-40810191.26991.68
5395766-39576688.51088.90
6403540-40354090.24990.66
60min1422106-42210694.40194.820.9794.9495.370.97
2421961-42196194.36994.92
3422795-42279594.55595.12
4430906-43090696.36996.94
5419523-41952393.82494.36
6426518-42651895.38895.94
极限1440947-44094798.61598.210.9599.3198.920.95
2436052-43605297.52098.22
3436391-43639197.59698.32
4445185-44518599.563100.29
5434446-43444697.16197.86
6441869-44186998.82199.54
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%
113.474478024493204484894484084473544482750.17
213.494468664466764467710.04
单位质量响应值RSD%判断
33279.5133118.680.35数据可信
供试品溶液-6000597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%
5min119417-194174.36510.9538.884.3610.9438.91
261017-6101713.71513.72
335252-352527.9247.92
448000-4800010.79010.79
556560-5656012.71412.71
671921-7192116.16716.17
10min1135608-13560830.48234.8312.3830.4934.8412.40
2153592-15359234.52534.55
3138047-13804731.03031.04
4150964-15096433.93433.95
5163409-16340936.73136.75
6187960-18796042.25042.28
15min1220114-22011449.47852.147.3349.5452.227.34
2224430-22443050.44850.53
3217884-21788448.97649.04
4225903-22590350.77950.85
5240928-24092854.15654.24
6262507-26250759.00759.10
20min1277889-27788962.46464.305.2262.6064.465.23
2276359-27635962.12062.28
3277333-27733362.33962.49
4277181-27718162.30562.46
5294747-29474766.25466.43
6312893-31289370.33370.53
30min1350686-35068678.82879.743.1279.0780.013.14
2345179-34517977.59077.86
3349324-34932478.52278.77
4347245-34724578.05478.32
5362136-36213681.40181.68
6373810-37381084.02684.34
45min1401531-40153190.25791.242.2590.6391.642.27
2395614-39561488.92789.32
3402787-40278790.53990.92
4401287-40128790.20290.60
5415019-41501993.28993.71
6419153-41915394.21894.67
60min1427376-42737696.06696.792.0396.5997.342.05
2420154-42015494.44394.99
3426525-42652595.87596.41
4426778-42677895.93296.48
5442040-44204099.36299.94
6440586-44058699.03699.65
极限1441135-44113599.159100.301.5099.85101.021.51
2438552-43855298.57899.28
3443407-44340799.670100.36
4446039-446039100.261100.96
5455704-455704102.434103.17
6452472-452472101.707102.48
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%
113.474490894501544492384491154507604496710.17
213.494477074471244474160.10
单位质量响应值RSD%判断
33383.1533166.490.47数据可信
供试品溶液-6000597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%
5min140770-407709.1448.9543.429.148.9443.43
259759-5975913.40213.40
321416-214164.8034.80
424610-246105.5195.52
561327-6132713.75413.75
631501-315017.0657.06
10min1145811-14581132.70132.5512.9432.7232.5612.95
2162786-16278636.50836.53
3129277-12927728.99329.00
4121195-12119527.18127.19
5169928-16992838.11038.13
6141812-14181231.80431.82
15min1227135-22713550.94050.028.5151.0150.088.52
2239572-23957253.72953.81
3211849-21184947.51247.57
4192751-19275143.22843.28
5244598-24459854.85654.94
6222176-22217649.82849.89
20min1284649-28464963.83962.595.4263.9962.745.44
2291898-29189865.46465.64
3271411-27141160.87061.01
4254544-25454457.08757.21
5295697-29569766.31666.49
6276199-27619961.94362.09
30min1354165-35416579.42978.222.7679.6978.482.78
2355997-35599779.84080.12
3347016-34701677.82678.06
4333909-33390974.88675.11
5359455-35945580.61580.90
6342163-34216376.73776.99
45min1405616-40561690.96890.221.7291.3690.601.73
2405494-40549490.94191.36
3406954-40695491.26891.63
4394584-39458488.49488.84
5408493-40849391.61392.04
6392422-39242288.00988.39
60min1429062-42906296.22695.441.2396.7795.981.25
2427944-42794495.97596.54
3428150-42815096.02296.54
4421491-42149194.52895.02
5429960-42996096.42897.00
6416846-41684693.48694.01
极限1447962-447962100.46599.411.50101.17100.101.50
2446673-446673100.176100.90
3447967-447967100.466101.14
4441505-44150599.01799.67
5444723-44472399.738100.47
6430619-43061996.57597.26
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