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100
标示量(mg)120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%
113.439174679172039160049162889155789165080.09
213.409183809156579170180.21
单位质量响应值RSD%判断
68243.3468434.180.20数据可信
供试品溶液-24041501-1批-pH1.2(内含2%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min16421-64210.7080.9415.710.710.9415.81
27924-79240.8730.87
38447-84470.9310.93
48883-88830.9790.98
510486-104861.1551.16
68999-89990.9920.99
10min125898-258982.8543.009.422.853.009.42
227771-277713.0603.06
326557-265572.9262.93
426819-268192.9552.96
531956-319563.5213.52
624423-244232.6912.69
15min144614-446144.9165.1210.464.925.1210.47
244350-443504.8874.89
346178-461785.0885.09
446036-460365.0735.08
555870-558706.1566.16
641816-418164.6084.61
20min163952-639527.0477.269.417.067.279.43
262470-624706.8836.90
365935-659357.2657.28
463968-639687.0487.06
578022-780228.5978.62
660832-608326.7036.72
30min1102818-10281811.32911.527.6111.3611.557.62
2100133-10013311.03311.06
3104628-10462811.52911.56
4101640-10164011.19911.23
5120107-12010713.23413.27
697961-9796110.79410.82
45min1155301-15530117.11217.255.6917.1617.305.69
2153295-15329516.89116.94
3156059-15605917.19617.24
4154577-15457717.03217.08
5173312-17331219.09719.15
6146609-14660916.15416.20
60min1197618-19761821.77521.804.1821.8521.884.19
2197095-19709521.71721.79
3196698-19669821.67321.75
4196600-19660021.66321.74
5212520-21252023.41723.50
6186788-18678820.58220.65
极限1259425-25942528.58528.222.9728.6928.332.98
2261097-26109728.76928.88
3247263-24726327.24527.36
4257032-25703228.32128.43
5265112-26511229.21229.34
6246475-24647527.15827.26
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100
标示量(mg)120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%
113.439130629115539114479115419110269117260.09
213.409119869144469132160.20
单位质量响应值RSD%判断
67887.2768150.450.28数据可信
供试品溶液-24041501-1批-pH1.2(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%
5min114432-144321.5981.3710.501.601.3610.58
212413-124131.3741.37
311319-113191.2531.25
413127-131271.4531.45
511788-117881.3051.30
610922-109221.2091.21
10min138791-387914.2943.937.244.303.937.26
232850-328503.6373.64
335413-354133.9203.92
438209-382094.2304.23
534849-348493.8583.86
632783-327833.6293.63
15min165507-655077.2526.637.377.266.637.38
254980-549806.0876.09
357675-576756.3856.39
464593-645937.1517.16
560263-602636.6716.68
656103-561036.2116.22
20min191017-9101710.0769.346.5910.109.366.60
278559-785598.6978.72
379796-797968.8348.85
490735-9073510.04510.07
585440-854409.4599.48
680675-806758.9318.95
30min1138492-13849215.33214.395.3415.3714.435.33
2124552-12455213.78913.82
3124582-12458213.79213.83
4138593-13859315.34315.38
5129834-12983414.37314.41
6124070-12407013.73513.77
45min1195128-19512821.60220.744.2521.6720.804.27
2182212-18221220.17220.23
3181238-18123820.06420.12
4198019-19801921.92221.99
5188885-18888520.91120.97
6178660-17866019.77919.83
60min1236423-23642326.17325.703.8726.2725.803.86
2228430-22843025.28825.38
3225718-22571824.98825.08
4246524-24652427.29127.39
5234598-23459825.97126.07
6221371-22137124.50724.60
极限1289387-28938732.03731.903.1832.1832.033.19
2284814-28481431.53031.66
3281304-28130431.14231.27
4304683-30468333.73033.88
5289528-28952832.05232.19
6278985-27898530.88531.02
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100
标示量(mg)120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%
113.439167689172349163899165669170509168010.04
213.409277179257429267300.16
单位质量响应值RSD%判断
68265.1569158.960.92数据可信
供试品溶液-24041501-1批-pH1.2(内含1%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min17216-72160.7910.8213.890.790.8214.00
25789-57890.6340.63
38159-81590.8940.89
48850-88500.9700.97
57192-71920.7880.79
67610-76100.8340.83
10min120985-209852.3002.0812.882.302.0812.81
216643-166431.8241.83
320969-209692.2982.30
421582-215822.3652.37
516572-165721.8161.82
617039-170391.8671.87
15min137351-373514.0933.5013.114.103.5013.08
229727-297273.2583.26
336766-367664.0294.03
431231-312313.4233.43
527593-275933.0243.03
628693-286933.1453.15
20min153914-539145.9095.0513.315.925.0613.26
245345-453454.9694.98
353013-530135.8105.82
444125-441254.8364.85
539292-392924.3064.32
640787-407874.4704.48
30min188306-883069.6788.4412.019.708.4512.03
278038-780388.5528.57
386773-867739.5109.53
473929-739298.1028.12
565292-652927.1567.17
669498-694987.6167.63
45min1136740-13674014.98613.219.9015.0213.259.88
2122955-12295513.47513.51
3130989-13098914.35514.39
4115492-11549212.65712.69
5105185-10518511.52711.56
6112012-11201212.27612.31
60min1192709-19270921.11917.7410.8721.1817.7910.87
2161285-16128517.67617.73
3169478-16947818.57318.63
4152205-15220516.68116.73
5143173-14317315.69115.74
6152109-15210916.67016.72
极限1219682-21968224.07522.944.6424.1723.024.66
2215600-21560023.62823.71
3218749-21874923.97324.07
4203051-20305122.25322.33
5198539-19853921.75821.83
6200434-20043421.96622.04
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