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D382/2305001对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.83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%
114.221874881878761874631871541870561874070.18
214.201864011864811864410.04
单位质量响应值RSD%判断
13179.1113129.650.27数据可信
供试品溶液-24040801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%
2min114613-146137.85210.6321.927.8510.6321.92
225178-2517813.52913.53
324178-2417812.99212.99
420447-2044710.98710.99
515631-156318.3998.40
618678-1867810.03610.04
5min193658-9365850.32650.264.2650.3350.264.26
294318-9431850.68050.68
397617-9761752.45352.45
495685-9568551.41551.41
585987-8598746.20446.20
693977-9397750.49750.50
10min1121630-12163065.35665.622.1265.3665.622.12
2122253-12225365.69165.69
3126449-12644967.94567.95
4121104-12110465.07365.07
5118518-11851863.68463.68
6122719-12271965.94165.94
15min1129731-12973169.70970.591.5769.7170.591.57
2132231-13223171.05271.05
3134999-13499972.53972.54
4130238-13023869.98169.98
5129540-12954069.60669.61
6131507-13150770.66370.66
20min1139120-13912074.75473.302.7774.7573.302.77
2137236-13723673.74173.74
3129644-12964469.66269.66
4140493-14049375.49275.49
5136396-13639673.29073.29
6135638-13563872.88372.88
30min1141791-14179176.18974.582.3176.1974.582.31
2138501-13850174.42174.42
3140672-14067275.58875.59
4140458-14045875.47375.47
5132815-13281571.36671.37
6138537-13853774.44174.44
45min1149068-14906880.09979.332.2280.1079.332.22
2146964-14696478.96978.97
3150423-15042380.82780.83
4151069-15106981.17481.17
5146044-14604478.47478.47
6142278-14227876.45176.45
60min1144137-14413777.45079.152.0777.4579.152.08
2144979-14497977.90277.90
3148623-14862379.86079.86
4152616-15261682.00682.01
5146304-14630478.61478.61
6147122-14712279.05479.05
极限1151772-15177281.55282.801.9381.5582.801.93
2154288-15428882.90482.90
3157964-15796484.87984.88
4155747-15574783.68883.69
5155148-15514883.36683.37
6149643-14964380.40880.41
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D382/2305001对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.83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%
114.221875301871501870091870651868151871140.15
214.201863651861911862780.07
单位质量响应值RSD%判断
13158.5113118.170.22数据可信
供试品溶液-24040802批-pH1.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
2min1120327-12032764.73558.718.2864.7358.708.28
294970-9497051.09351.09
3108336-10833658.28458.28
4107279-10727957.71557.71
5106326-10632657.20257.20
6117487-11748763.20763.21
5min1171207-17120792.10792.190.7092.1192.190.70
2171526-17152692.27992.28
3169764-16976491.33191.33
4173282-17328293.22493.22
5170537-17053791.74791.75
6171799-17179992.42692.43
10min1176638-17663895.02995.530.8295.0395.540.82
2180285-18028596.99196.99
3176493-17649394.95194.95
4178069-17806995.79995.80
5176659-17665995.04195.04
6177323-17732395.39895.40
15min1177882-17788295.69996.411.0995.7096.411.09
2181508-18150897.64997.65
3178231-17823195.88695.89
4181712-18171297.75997.76
5177115-17711595.28695.29
6178728-17872896.15496.15
20min1178462-17846296.01196.891.0896.0196.891.08
2182802-18280298.34598.35
3178998-17899896.29996.30
4182350-18235098.10298.10
5178765-17876596.17496.17
6179241-17924196.43096.43
30min1179715-17971596.68597.061.4996.6897.061.49
2183963-18396398.97098.97
3177941-17794195.73095.73
4183485-18348598.71398.71
5179474-17947496.55596.56
6177920-17792095.71995.72
45min1180134-18013496.91097.491.1396.9197.491.13
2183974-18397498.97698.98
3180145-18014596.91696.92
4183658-18365898.80698.81
5179531-17953196.58696.59
6179831-17983196.74796.75
60min1179951-17995196.81297.481.1896.8197.481.18
2183883-18388398.92798.93
3180171-18017196.93096.93
4183936-18393698.95698.96
5179309-17930996.46696.47
6179861-17986196.76396.76
极限1178141-17814195.83897.181.3495.8497.181.34
2183960-18396098.96898.97
3179692-17969296.67296.67
4183366-18336698.64998.65
5179322-17932296.47396.47
6179390-17939096.51096.51
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