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)1.5补液体积(ml)0
对照品批号382/2305001对照品来源工作对照品能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%
114.011810271802091809791807611812821808520.23
214.091824861824481824670.02
单位质量响应值RSD%判断
12908.7812950.110.23数据可信
供试品溶液-2733947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%
2min118336-1833610.0817.5965.9410.087.5965.93
24649-46492.5562.56
317690-176909.7269.73
47443-74434.0924.09
56663-66633.6633.66
628072-2807215.43415.43
5min1105208-10520857.84457.3819.1957.8657.3919.20
279622-7962243.77643.78
3117887-11788764.81564.83
4104497-10449757.45357.46
585427-8542746.96846.97
6133517-13351773.40873.43
10min1157270-15727086.46784.746.7186.5884.846.73
2148185-14818581.47281.55
3157466-15746686.57586.70
4156380-15638085.97886.08
5137409-13740975.54875.63
6168036-16803692.38792.53
15min1168240-16824092.49991.993.0492.7692.243.06
2167534-16753492.11192.32
3165937-16593791.23391.50
4169182-16918293.01793.26
5158713-15871387.26187.47
6174284-17428495.82296.12
20min1174836-17483696.12594.532.2296.5494.932.23
2173895-17389595.60895.97
3169977-16997793.45493.87
4171831-17183194.47394.87
5165428-16542890.95391.31
6175644-17564496.57097.03
30min1178038-17803897.88695.881.8798.4696.441.88
2177044-17704497.33997.87
3171512-17151294.29894.87
4172088-17208894.61495.17
5170806-17080693.91094.42
6176848-17684897.23197.85
45min1179386-17938698.62796.911.3799.3697.631.37
2178560-17856098.17398.86
3174831-17483196.12396.86
4174788-17478896.09996.81
5173192-17319295.22195.89
6176831-17683197.22298.01
60min1179490-17949098.68497.241.7699.5898.121.77
2179617-17961798.75499.61
3175327-17532796.39597.29
4174754-17475496.08096.96
5172413-17241394.79395.62
6179549-17954998.71699.66
极限1181480-18148099.77898.661.27100.8499.701.24
2180170-18017099.058100.07
3178359-17835998.06299.12
4175561-17556196.52497.56
5181599-18159999.844100.82
6179528-17952898.70599.82
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)1.5补液体积(ml)0
对照品批号382/2305001对照品来源工作对照品能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%
114.011815371811801812241804651812061811220.22
214.091845221847311846260.09
单位质量响应值RSD%判断
12928.0513103.340.96数据可信
供试品溶液-2733947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%
2min121336-2133611.6537.0762.8011.657.0762.79
210543-105435.7585.76
3-0.0000.00
411953-119536.5296.53
511710-117106.3966.40
622111-2211112.07712.08
5min195656-9565652.24652.489.7352.2752.509.74
286411-8641147.19647.21
389278-8927848.76248.76
499061-9906154.10554.12
593293-9329350.95550.97
6112824-11282461.62261.64
10min1128805-12880570.35171.609.6970.4671.709.70
2123225-12322567.30367.39
3123042-12304267.20367.28
4133696-13369673.02273.12
5122339-12233966.81966.92
6155393-15539384.87385.00
15min1141707-14170777.39877.607.9977.6277.828.00
2135770-13577074.15574.36
3134346-13434673.37773.57
4141938-14193877.52477.75
5134530-13453073.47873.68
6164133-16413389.64789.91
20min1147194-14719480.39579.767.4380.7580.117.44
2139572-13957276.23276.56
3137531-13753175.11775.43
4146570-14657080.05480.41
5138821-13882175.82276.15
6166522-16652290.95191.37
30min1151233-15123382.60181.417.3383.0981.897.34
2142064-14206477.59378.04
3139564-13956476.22776.67
4149665-14966581.74482.23
5142524-14252477.84478.30
6169288-16928892.46293.03
45min1155629-15562985.00284.165.7885.6384.785.80
2148724-14872481.23081.81
3146373-14637379.94680.51
4154497-15449784.38485.01
5148666-14866681.19981.78
6170672-17067293.21893.94
60min1158155-15815586.38185.655.7887.1586.405.80
2149879-14987981.86182.58
3148432-14843281.07181.77
4157865-15786586.22386.99
5153114-15311483.62884.35
6173400-17340094.70895.58
极限1177346-17734696.86396.232.1297.7797.132.16
2171088-17108893.44594.30
3174015-17401595.04495.88
4179660-17966098.12799.03
5174223-17422395.15896.02
6180823-18082398.76299.79
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