盐酸达泊西汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DSZJ-4057-240226对照品来源自制工作对照品对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数2000
标示量(mg)30供试品稀释倍数5系数0.8934
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.882065432068742064412065142065182065780.09
215.952082732088362085540.20
单位质量响应值RSD%判断
13008.6913075.490.37数据可信
供试品溶液-2024042721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%
5min123970-2397012.31522.5337.3312.3122.5337.34
233677-3367717.30217.30
359299-5929930.46630.47
436962-3696218.99018.99
541858-4185821.50521.51
667313-6731334.58334.58
10min197231-9723149.95457.2911.3350.0257.4211.37
2117002-11700260.11160.21
3124269-12426963.84564.01
497344-9734450.01250.12
5108021-10802155.49755.62
6125198-12519864.32264.51
15min1119213-11921361.24766.997.5261.5967.437.54
2140019-14001971.93772.37
3141398-14139872.64573.17
4119812-11981261.55561.94
5134733-13473369.22169.65
6127168-12716865.33465.88
20min1129720-12972066.64573.196.9467.3374.006.98
2149516-14951676.81677.65
3147895-14789575.98376.91
4130676-13067667.13767.86
5144261-14426174.11674.93
6152646-15264678.42479.34
30min1137019-13701970.39576.367.1171.4577.587.15
2154725-15472579.49280.75
3154244-15424479.24580.59
4135825-13582569.78270.88
5147565-14756575.81377.04
6162375-16237583.42284.77
45min1134479-13447969.09076.967.5570.5478.617.57
2157345-15734580.83882.54
3151537-15153777.85479.64
4138815-13881571.31872.80
5152065-15206578.12579.77
6164564-16456484.54786.36
60min1140686-14068672.27978.786.5874.1180.856.62
2158998-15899881.68783.83
3153051-15305178.63280.85
4143312-14331273.62875.51
5156224-15622480.26282.34
6167742-16774286.18088.46
极限1149548-14954876.83281.665.3279.0784.175.39
2167434-16743486.02188.62
3159638-15963882.01684.68
4148377-14837776.23178.52
5160686-16068682.55585.08
6167997-16799786.31189.07
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