氢溴酸替格列汀片项目信息
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DMAD-P/23001对照品来源自制对照品使用方法直接使用
对照品含量(%)95.04对照品水分(%)0对照品稀释倍数250
标示量(mg)40供试品稀释倍数1系数0.6784
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.626798526810746805066793306787876799100.14
214.636820576816456818510.05
单位质量响应值RSD%判断
46505.4746606.360.16数据可信
供试品溶液-2025011121批-水
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1255462-25546231.84127.7424.8631.8427.7424.85
2183419-18341922.86222.86
3269580-26958033.60133.60
4253381-25338131.58231.58
5245804-24580430.63730.64
6127794-12779415.92815.93
10min1522920-52292065.17757.1222.5565.2357.1722.55
2382402-38240247.66347.70
3534091-53409166.57066.63
4522218-52221865.09065.14
5506636-50663663.14863.20
6281508-28150835.08735.11
15min1698330-69833087.04081.0711.1187.2081.2111.13
2599439-59943974.71574.83
3692502-69250286.31486.48
4710422-71042288.54888.71
5674935-67493584.12484.28
6527101-52710165.69865.78
20min1783215-78321597.62195.104.0397.9395.384.07
2741721-74172192.44992.69
3764771-76477195.32295.63
4802932-802932100.078100.39
5769320-76932095.88996.19
6715869-71586989.22789.42
30min1789601-78960198.41799.461.7498.8999.901.71
2807505-807505100.648101.04
3774261-77426196.50596.97
4811920-811920101.198101.67
5801584-80158499.910100.37
6803120-803120100.102100.44
45min1801138-80113899.85599.731.52100.49100.331.51
2799734-79973499.680100.24
3777359-77735996.89197.52
4813342-813342101.376102.02
5805547-805547100.404101.03
6803491-803491100.148100.66
极限1793776-79377698.937100.051.4999.74100.811.46
2805201-805201100.361101.09
3783757-78375797.68898.48
4816711-816711101.796102.61
5806754-806754100.555101.34
6809840-809840100.939101.62
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