枸橼酸西地那非片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号420012-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.8对照品水分(%)0对照品稀释倍数500
标示量(mg)25供试品稀释倍数1系数0.7118
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
117.36 2368732373362373502370732374992372260.11
217.31 2354712367912361310.40
单位质量响应值RSD%判断
13665.0913641.310.13数据可信
供试品溶液-2024051611批-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1263249-26324997.62999.492.6397.6399.492.63
2273383-273383101.388101.39
3279503-279503103.657103.66
4268302-26830299.50399.50
5264188-26418897.97897.98
6260946-26094696.77596.78
10min1264630-26463098.14198.491.0098.3098.651.00
2263739-26373997.81197.98
3265335-26533598.40398.58
4270607-270607100.358100.52
5265729-26572998.54998.71
6263303-26330397.64997.81
15min1263414-26341497.69097.871.1698.0298.201.16
2261967-26196797.15497.49
3263353-26335397.66898.00
4269865-269865100.083100.42
5263484-26348497.71698.04
6261357-26135796.92897.25
20min1262311-26231197.28197.421.0497.7797.911.04
2260825-26082596.73097.22
3263133-26313397.58698.09
4267808-26780899.32099.82
5261754-26175497.07597.57
6260213-26021396.50396.99
30min1274873-274873101.94097.712.38102.5998.362.36
2258079-25807995.71296.37
3261919-26191997.13697.80
4266165-26616598.71199.38
5260475-26047596.60197.25
6259253-25925396.14796.79
45min1258519-25851995.87596.370.9696.7097.190.96
2257908-25790895.64896.46
3259696-25969696.31297.14
4264746-26474698.18499.01
5259587-25958796.27197.08
6258677-25867795.93496.74
极限1257546-25754695.51495.961.0796.5096.941.07
2256547-25654795.14496.12
3258824-25882495.98896.97
4264063-26406397.93198.92
5258642-25864295.92196.89
6256841-25684195.25396.22
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