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对照品来源工作对照品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%
114.151812561812921812491811571813151812540.04
214.181818051816561817300.06
单位质量响应值RSD%判断
12809.4712815.940.04数据可信
供试品溶液-2024051221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%
2min1136335-13633575.21171.529.0075.2171.519.00
2130913-13091372.22072.22
3130696-13069672.10072.10
4106540-10654058.77458.77
5136358-13635875.22375.22
6136974-13697475.56375.56
5min1173663-17366395.80394.521.4895.8094.521.48
2167872-16787292.60892.61
3173539-17353995.73595.73
4172325-17232595.06595.06
5168512-16851292.96192.96
6172100-17210094.94194.94
10min1178032-17803298.21396.641.6798.2196.641.67
2173806-17380695.88295.88
3177881-17788198.13098.13
4176349-17634997.28597.28
5170300-17030093.94893.95
6174677-17467796.36296.36
15min1178152-17815298.27997.061.3998.2897.051.39
2172921-17292195.39495.39
3177944-17794498.16598.16
4176440-17644097.33597.33
5172867-17286795.36495.36
6177271-17727197.79397.79
20min1179252-17925298.88697.311.5598.8997.311.55
2173428-17342895.67395.67
3178349-17834998.38898.39
4176328-17632897.27397.27
5172783-17278395.31895.32
6178263-17826398.34198.34
30min1178717-17871798.59196.911.7498.5996.911.74
2174138-17413896.06596.07
3178783-17878398.62898.63
4173181-17318195.53795.54
5171725-17172594.73494.73
6177473-17747397.90597.90
45min1179237-17923798.87897.871.2898.8897.871.28
2175517-17551796.82696.83
3179489-17948999.01799.02
4177742-17774298.05398.05
5173821-17382195.89095.89
6178643-17864398.55098.55
60min1179965-17996599.28097.881.4599.2897.881.45
2174500-17450096.26596.26
3178347-17834798.38798.39
4177669-17766998.01398.01
5174156-17415696.07596.08
6179915-17991599.25299.25
极限1179588-17958899.07297.691.2899.0797.681.28
2175776-17577696.96996.97
3179703-17970399.13599.14
4176922-17692297.60197.60
5173842-17384295.90295.90
6176616-17661697.43297.43
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对照品来源工作对照品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%
114.151805451804291803961803961804791804490.04
214.181820461819061819760.06
单位质量响应值RSD%判断
12752.5812833.290.45数据可信
供试品溶液-2024051221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%
2min1121574-12157467.17265.8326.2667.1765.8326.26
2123943-12394368.48168.48
3146911-14691181.17181.17
457931-5793132.00832.01
5133248-13324873.62273.62
6131239-13123972.51272.51
5min1166002-16600291.71993.682.4991.7293.682.49
2174858-17485896.61296.61
3172122-17212295.10195.10
4164613-16461390.95290.95
5172728-17272895.43595.44
6166959-16695992.24892.25
10min1174169-17416996.23296.471.6396.2396.471.63
2172815-17281595.48495.48
3179658-17965899.26499.26
4173570-17357095.90195.90
5175817-17581797.14297.14
6171617-17161794.82294.82
15min1175060-17506096.72497.141.6196.7297.141.61
2176852-17685297.71497.71
3179034-17903498.92098.92
4173334-17333495.77095.77
5178550-17855098.65298.65
6172056-17205695.06495.06
20min1174469-17446996.39796.491.4896.4096.491.48
2178691-17869198.73098.73
3175994-17599497.24097.24
4172683-17268395.41195.41
5174727-17472796.54096.54
6171283-17128394.63794.64
30min1174195-17419596.24697.771.8596.2597.761.85
2178653-17865398.70998.71
3181045-181045100.031100.03
4175278-17527896.84496.84
5179599-17959999.23299.23
6172907-17290795.53495.53
45min1176043-17604397.26797.681.5097.2797.681.50
2179945-17994599.42399.42
3176816-17681697.69497.69
4175191-17519196.79696.80
5179629-17962999.24899.25
6173105-17310595.64495.64
60min1175211-17521196.80796.351.8496.8196.351.84
2174656-17465696.50196.50
3177264-17726497.94297.94
4168308-16830892.99392.99
5176689-17668997.62497.62
6174142-17414296.21796.22
极限1176107-17610797.30297.681.8197.3097.681.81
2179050-17905098.92898.93
3180710-18071099.84699.85
4175005-17500596.69496.69
5178063-17806398.38398.38
6171788-17178894.91694.92
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