他达拉非片项目信息
介质体积(ml)1000取样体积(ml)0补液体积(ml)0
对照品批号D533-190826对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.93对照品水分(%)0对照品稀释倍数625
标示量(mg)20供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.591286131291911288301292071284611288600.27
212.651292861294841293850.11
单位质量响应值RSD%判断
10235.1110228.060.05数据可信
供试品溶液-shui(内含0.5%SDS)
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
20240301211126781-12678199.06101.091.3499.67%~102.51%
2128864-128864100.69
3130987-130987102.35
4130544-130544102.00
5128142-128142100.12
6130945-130945102.31
20240302211122554-12255495.7698.401.7196.65%~100.16%
2128260-128260100.22
3125720-12572098.23
4127224-12722499.41
5124461-12446197.25
6127423-12742399.56
20240303211128827-128827100.66102.601.58100.91%~104.30%
2129730-129730101.36
3132077-132077103.20
4134101-134101104.78
5130135-130135101.68
6133022-133022103.94
他达拉非片项目信息
介质体积(ml)1000取样体积(ml)0补液体积(ml)0
对照品批号D533-190826对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.93对照品水分(%)0对照品稀释倍数625
标示量(mg)20供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.592521282528642524292521072530132525080.17
212.652521362521592521480.01
单位质量响应值RSD%判断
20056.2419932.650.44数据可信
供试品溶液-shui(内含0.5%SDS)
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
20240301211256076-256076102.39104.061.64102.27%~105.84%
2254655-254655101.82
3262785-262785105.07
4262591-262591104.99
5265681-265681106.23
6259686-259686103.83
20240302211257049-257049102.78103.001.53101.35%~104.65%
2256422-256422102.53
3257650-257650103.02
4257587-257587102.99
5252379-252379100.91
6264529-264529105.77
20240303211260668-260668104.22103.771.37102.29%~105.26%
2260283-260283104.07
3262972-262972105.15
4256285-256285102.47
5254266-254266101.66
6262759-262759105.06
他达拉非片项目信息
介质体积(ml)1000取样体积(ml)0补液体积(ml)0
对照品批号D533-190826对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.93对照品水分(%)0对照品稀释倍数625
标示量(mg)20供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.595045235039405047885043475043855043970.07
212.655086905097385092140.15
单位质量响应值RSD%判断
40063.3040254.070.34数据可信
供试品溶液-shui(内含0.5%SDS)
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
20240301211493239-49323998.19100.932.0698.75%~103.11%
2495434-49543498.63
3512823-512823102.09
4508772-508772101.28
5519678-519678103.45
6511980-511980101.92
20240302211526974-526974104.91104.241.37102.74%~105.73%
2527383-527383104.99
3532695-532695106.04
4512464-512464102.02
5523546-523546104.22
6518603-518603103.24
20240303211511036-511036101.73101.060.99100.01%~102.10%
2508642-508642101.26
3509417-509417101.41
4504858-504858100.50
5512830-512830102.09
6499026-49902699.34
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