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%
113.474596854619454629044621854623144618070.27
213.434590114598854594480.14
单位质量响应值RSD%判断
34284.1134210.570.16数据可信
供试品溶液-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%
5min114151-141513.1113.9113.473.113.9113.48
219940-199404.3844.38
319006-190064.1794.18
420321-203214.4684.47
517162-171623.7733.77
616197-161973.5613.56
10min166387-6638714.59716.097.9614.6316.147.98
279154-7915417.40417.45
380412-8041217.68017.73
474367-7436716.35116.40
567728-6772814.89114.93
671096-7109615.63215.67
15min1132191-13219129.06530.335.3729.2630.555.39
2147024-14702432.32632.57
3146867-14686732.29232.53
4137281-13728130.18430.42
5129862-12986228.55328.76
6134375-13437529.54529.76
20min1191941-19194142.20242.863.8342.7243.423.86
2205411-20541145.16445.77
3202259-20225944.47145.07
4194123-19412342.68243.25
5186153-18615340.93041.45
6189724-18972441.71542.26
30min1280134-28013461.59361.682.6662.5862.712.69
2291547-29154764.10365.21
3282319-28231962.07463.17
4284419-28441962.53663.58
5270989-27098959.58360.56
6273666-27366660.17161.18
45min1360094-36009479.17478.782.5980.8580.502.59
2370656-37065681.49783.31
3353834-35383477.79879.58
4367043-36704380.70282.44
5347573-34757376.42178.06
6350520-35052077.06978.74
60min1405177-40517789.08788.262.4991.6490.852.49
2414490-41449091.13493.86
3392983-39298386.40689.06
4410285-41028590.21092.84
5390192-39019285.79288.28
6395234-39523486.90189.43
极限1438285-43828596.36695.502.3299.9199.082.31
2446199-44619998.106101.84
3422749-42274992.95096.56
4441477-44147797.068100.70
5421576-42157692.69296.14
6435741-43574195.80799.30
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%
113.474593074593504593984597874597884595260.06
213.434684574688384686480.06
单位质量响应值RSD%判断
34114.7734895.611.61数据可信
供试品溶液-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%
5min194929-9492920.71920.883.6520.7220.883.65
296358-9635821.03121.03
394837-9483720.69920.70
4101245-10124522.09722.10
590386-9038619.72719.73
696124-9612420.98020.98
10min1256528-25652855.98957.012.5356.2257.242.53
2266365-26636558.13658.37
3258124-25812456.33756.57
4271545-27154559.26659.51
5253973-25397355.43155.65
6260747-26074756.91057.14
15min1351187-35118776.64977.391.7377.5078.261.74
2356489-35648977.80678.69
3350504-35050476.50077.36
4365596-36559679.79480.70
5348768-34876876.12176.96
6355067-35506777.49578.36
20min1399274-39927487.14487.861.5588.8589.591.56
2403930-40393088.16089.90
3397893-39789386.84388.55
4414122-41412290.38592.18
5397499-39749986.75788.44
6402598-40259887.86989.60
30min1437547-43754795.49796.381.3998.1799.081.41
2442687-44268796.61999.34
3436803-43680395.33598.01
4452966-45296698.863101.66
5437344-43734495.45398.10
6442164-44216496.50599.21
45min1454995-45499599.30599.941.11103.04103.711.13
2457708-45770899.898103.69
3453931-45393199.073102.80
4467496-467496102.034105.93
5454671-45467199.235102.94
6458579-458579100.088103.86
60min1460450-460450100.496100.871.02105.33105.761.05
2463142-463142101.084105.99
3457456-45745699.843104.67
4470678-470678102.728107.76
5458695-458695100.113104.92
6462655-462655100.977105.86
极限1464545-464545101.390101.280.79107.34107.280.82
2466463-466463101.808107.84
3462680-462680100.983106.92
4469483-469483102.467108.64
5459109-459109100.203106.12
6462007-462007100.836106.84
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%
113.474613434597764608504608154598584605280.15
213.434592844593814593320.02
单位质量响应值RSD%判断
34189.1634201.940.03数据可信
供试品溶液-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%
5min118874-188744.1564.478.864.164.478.84
221561-215614.7484.75
323361-233615.1445.14
419682-196824.3344.33
518777-187774.1354.13
619596-195964.3154.32
10min174609-7460916.42917.196.7316.4817.246.73
280112-8011217.64117.69
386842-8684219.12319.18
476285-7628516.79816.85
571675-7167515.78315.83
678837-7883717.36017.41
15min1121737-12173726.80730.226.8727.0430.466.85
2138196-13819630.43130.68
3151291-15129133.31533.58
4137917-13791730.37030.60
5135598-13559829.85930.08
6138609-13860930.52230.76
20min1182380-18238040.16142.273.6040.6942.853.63
2190953-19095342.04942.64
3203240-20324044.75445.39
4195018-19501842.94443.52
5191264-19126442.11742.67
6188992-18899241.61742.20
30min1253056-25305655.72459.263.7756.7060.313.79
2270351-27035159.53260.59
3284641-28464162.67963.82
4267144-26714458.82659.88
5267726-26772658.95459.98
6271871-27187159.86760.91
45min1320556-32055670.58873.632.7472.1875.342.78
2339209-33920974.69576.41
3347596-34759676.54278.38
4336850-33685074.17675.88
5330755-33075572.83474.51
6331286-33128672.95174.66
60min1359244-35924479.10782.021.9681.4884.551.96
2373044-37304482.14684.69
3372085-37208581.93584.62
4380385-38038583.76286.29
5372624-37262482.05384.54
6377563-37756383.14185.66
极限1403349-40334988.81989.041.9792.0792.471.96
2408687-40868789.99593.45
3412752-41275290.89094.48
4406356-40635689.48192.94
5389551-38955185.78189.18
6405323-40532389.25492.70
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%
113.474607124603244604734603644607854605320.05
213.434712414722264717340.15
单位质量响应值RSD%判断
34189.4635125.391.91数据可信
供试品溶液-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%
5min195333-9533320.71723.479.6320.7223.489.63
2109207-10920723.73223.73
3103488-10348822.48922.49
4124603-12460327.07727.08
5101312-10131222.01622.02
6114185-11418524.81324.81
10min1257530-25753055.96458.644.7256.1958.904.74
2266985-26698558.01858.28
3257021-25702155.85356.10
4289317-28931762.87163.17
5268307-26830758.30658.55
6280055-28005560.85861.13
15min1345445-34544575.06878.993.3275.9279.903.34
2368437-36843780.06580.97
3354903-35490377.12477.99
4380474-38047482.68083.68
5367136-36713679.78280.67
6364483-36448379.20580.16
20min1395457-39545785.93687.942.5387.6289.732.53
2403168-40316887.61289.41
3397476-39747686.37588.10
4416238-41623890.45292.37
5418502-41850290.94492.72
6397162-39716286.30788.14
30min1425577-42557792.48293.041.4895.1295.811.50
2421721-42172191.64494.42
3426319-42631992.64395.33
4437994-43799495.18098.10
5433670-43367094.24097.03
6423649-42364992.06394.85
45min1402499-40249987.46794.114.7791.1497.924.67
2424677-42467792.28696.08
3421994-42199491.70395.42
4449594-44959497.701101.68
5458897-45889799.722103.56
6440864-44086495.80499.62
60min1387034-38703484.10694.586.3288.7599.426.14
2433065-43306594.10998.92
3430272-43027293.50298.24
4453532-45353298.557103.62
5468031-468031101.707106.65
6439343-43934395.473100.35
极限1427486-42748692.89794.382.7998.47100.282.76
2427158-42715892.82598.69
3419654-41965491.19596.97
4434182-43418294.352100.51
5450069-45006997.804103.88
6447414-44741497.227103.17
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