氢溴酸伏硫西汀口崩片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号171336-202301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(%)99.9对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数0.7867
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.181822501825991803141820611804171815280.60
214.231823091821011822050.09
单位质量响应值RSD%判断
12801.6912804.290.02数据可信
供试品溶液-2025102521批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
2min1145168-14516880.20072.2410.3280.2072.2410.32
2136502-13650275.41375.41
3129354-12935471.46471.46
4129644-12964471.62471.62
5105961-10596158.54058.54
6137934-13793476.20476.20
5min1174123-17412396.19796.272.3796.2096.272.37
2173035-17303595.59695.60
3178509-17850998.62098.62
4177952-17795298.31298.31
5167090-16709092.31292.31
6174847-17484796.59796.60
10min1176613-17661397.57398.951.4097.5798.951.40
2178549-17854998.64298.64
3181103-181103100.053100.05
4175944-17594497.20397.20
5180326-18032699.62499.62
6182146-182146100.630100.63
15min1181138-181138100.07399.621.44100.0799.621.44
2177989-17798998.33398.33
3184662-184662102.020102.02
4181082-181082100.042100.04
5177672-17767298.15898.16
6179397-17939799.11199.11
20min1177890-17789098.27898.840.8698.2898.840.86
2178110-17811098.40098.40
3181944-181944100.518100.52
4178179-17817998.43898.44
5178984-17898498.88398.88
6178386-17838698.55298.55
30min1175706-17570697.07298.841.3497.0798.841.34
2177154-17715497.87297.87
3178357-17835798.53698.54
4181170-181170100.090100.09
5182065-182065100.585100.58
6178947-17894798.86298.86
45min1176227-17622797.35999.081.4297.3699.081.41
2179230-17923099.01999.02
3180760-18076099.86499.86
4176910-17691097.73797.74
5179768-17976899.31699.32
6183111-183111101.163101.16
60min1176870-17687097.71599.201.7597.7199.201.75
2175224-17522496.80596.81
3184065-184065101.690101.69
4180243-18024399.57899.58
5179906-17990699.39299.39
6181075-181075100.038100.04
极限1178164-17816498.43099.410.9698.4399.400.96
2179561-17956199.20199.20
3182393-182393100.766100.77
4179655-17965599.25399.25
5178258-17825898.48298.48
6181554-181554100.302100.30
氢溴酸伏硫西汀口崩片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号171336-202301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(%)99.9对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数0.7867
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.181835991814891801971820921807101816170.73
214.231830741819631825180.44
单位质量响应值RSD%判断
12807.9712826.280.11数据可信
供试品溶液-2025102521批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
2min1123554-12355468.18470.473.0868.1870.473.08
2125901-12590169.47969.48
3131793-13179372.73172.73
4123241-12324168.01168.01
5131105-13110572.35172.35
6130571-13057172.05772.06
5min1175615-17561596.91496.340.8296.9196.340.82
2173106-17310695.53095.53
3175563-17556396.88696.89
4172698-17269895.30595.30
5174362-17436296.22396.22
6176080-17608097.17197.17
10min1181049-18104999.91398.921.2399.9198.921.23
2176861-17686197.60297.60
3179755-17975599.19999.20
4176471-17647197.38797.39
5179438-17943899.02499.02
6181917-181917100.392100.39
15min1185530-185530102.38699.552.14102.3999.562.14
2176598-17659897.45797.46
3178760-17876098.65098.65
4176634-17663497.47797.48
5180413-18041399.56299.56
6184447-184447101.788101.79
20min1176948-17694897.65099.221.8497.6599.221.84
2177870-17787098.15998.16
3180237-18023799.46599.47
4177089-17708997.72897.73
5181002-18100299.88799.89
6185600-185600102.425102.42
30min1177796-17779698.11898.962.0498.1298.972.04
2175786-17578697.00997.01
3183428-183428101.226101.23
4177053-17705397.70897.71
5177456-17745697.93097.93
6184465-184465101.798101.80
45min1180800-18080099.77699.971.6299.7899.981.62
2179581-17958199.10399.10
3181063-18106399.92199.92
4180002-18000299.33599.34
5178626-17862698.57698.58
6186873-186873103.127103.13
60min1183286-183286101.14898.862.00101.1598.862.00
2177187-17718797.78297.78
3180224-18022499.45899.46
4179525-17952599.07299.07
5173118-17311895.53695.54
6181483-181483100.153100.15
极限1179141-17914198.860100.261.6298.86100.271.62
2179612-17961299.12099.12
3183626-183626101.335101.34
4183192-183192101.096101.10
5178681-17868198.60698.61
6185866-185866102.571102.57
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