坎地沙坦酯片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号61123040205对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)100.5对照品水分(%)0.14对照品稀释倍数4000
标示量(mg)8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%
116.101900311901181901311899491900001900460.05
216.171899661898381899020.05
单位质量响应值RSD%判断
11804.1011744.090.37数据可信
供试品溶液-24110402批-pH6.8(内含0.35%吐温20)
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min134429-3442916.50717.023.1816.5117.023.18
237378-3737817.92117.92
334682-3468216.62916.63
435782-3578217.15617.16
534684-3468416.63016.63
636013-3601317.26717.27
10min188959-8895942.65343.923.8542.8444.113.85
292212-9221244.21244.41
385991-8599141.23041.41
495432-9543245.75645.95
594315-9431545.22145.41
692729-9272944.46044.65
15min1138580-13858066.44469.238.4167.1069.918.32
2147622-14762270.77971.47
3150377-15037772.10072.74
4128750-12875061.73162.43
5137530-13753065.94166.63
6163495-16349578.39079.08
20min1172368-17236882.64483.740.7984.0485.180.78
2173982-17398283.41884.89
3175333-17533384.06685.51
4175885-17588584.33085.72
5175983-17598384.37785.80
6174353-17435383.59685.15
30min1194610-19461093.30894.180.7995.6296.560.79
2198636-19863695.23997.64
3195174-19517493.57995.96
4197751-19775194.81497.14
5195857-19585793.90696.26
6196530-19653094.22996.71
45min1195727-19572793.84497.201.9997.19100.631.96
2200832-20083296.29299.75
3204006-20400697.813101.23
4203192-20319297.423100.80
5205782-20578298.665102.07
6206876-20687699.189102.72
60min1204425-20442598.01497.311.31102.41101.811.25
2198208-19820895.03399.57
3205638-20563898.596103.10
4201653-20165396.685101.14
5203796-20379697.713102.21
6203967-20396797.795102.43
极限1202767-20276797.21997.470.70102.70103.060.65
2200989-20098996.367101.95
3204415-20441598.009103.61
4204820-20482098.204103.74
5203976-20397697.799103.38
6202812-20281297.241102.96
坎地沙坦酯片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号61123040205对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)100.5对照品水分(%)0.14对照品稀释倍数4000
标示量(mg)8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%
116.101901571900671903181903041899601901610.09
216.171906141904211905180.08
单位质量响应值RSD%判断
11811.2411782.190.18数据可信
供试品溶液-24110402批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
10min13536-35361.6921.939.781.691.939.83
24208-42082.0142.01
33624-36241.7341.73
44211-42112.0152.02
54048-40481.9371.94
64580-45802.1922.19
15min16078-60782.9092.974.062.932.994.13
26590-65903.1543.18
35940-59402.8432.86
46124-61242.9312.95
56082-60822.9102.93
66453-64533.0883.11
20min17638-76383.6553.693.583.713.743.57
28007-80073.8323.89
37424-74243.5533.60
47425-74253.5533.61
58059-80593.8573.91
67673-76733.6723.73
30min18888-88884.2534.433.224.354.523.14
29508-95084.5504.65
39390-93904.4944.58
48917-89174.2674.36
59587-95874.5884.68
69249-92494.4264.53
45min19928-99284.7514.992.814.895.132.79
210326-103264.9415.09
310502-105025.0265.17
410468-104685.0095.15
510824-108245.1805.33
610464-104645.0075.16
60min110658-106585.1005.374.475.295.574.39
211072-110725.2985.50
310967-109675.2485.44
410974-109745.2525.45
511929-119295.7095.91
611759-117595.6275.83
极限110960-109605.2455.483.055.495.743.07
211625-116255.5635.83
311457-114575.4835.74
411126-111265.3245.58
511890-118905.6905.96
611644-116445.5725.84
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