氨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MAD-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(%)94.94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%
115.106821696805536817106815136818306815550.09
215.066813596817436815510.04
单位质量响应值RSD%判断
45136.0945255.710.19数据可信
供试品溶液-24032601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%
5min1258579-25857933.16434.462.9133.1634.462.91
2277977-27797735.65235.65
3259749-25974933.31433.31
4270502-27050234.69434.69
5273558-27355835.08635.09
6271557-27155734.82934.83
10min1546690-54669070.11772.702.1770.1772.762.17
2563570-56357072.28172.34
3567808-56780872.82572.88
4583689-58368974.86274.92
5573857-57385773.60173.66
6565598-56559872.54272.60
15min1715334-71533491.74694.351.8091.9294.521.80
2728251-72825193.40393.58
3743286-74328695.33195.51
4753636-75363696.65996.84
5739484-73948494.84495.02
6733631-73363194.09394.27
20min1762212-76221297.75999.371.7298.0899.711.72
2766849-76684998.35398.69
3788449-788449101.124101.46
4794519-794519101.902102.25
5769961-76996198.75299.09
6766706-76670698.33598.67
30min1764268-76426898.02299.351.7398.5199.861.72
2768670-76867098.58799.09
3787712-787712101.029101.53
4795191-795191101.988102.50
5767679-76767998.46098.96
6764413-76441398.04198.54
45min1762968-76296897.85699.221.7298.5199.891.72
2765925-76592598.23598.90
3787469-787469100.998101.67
4793397-793397101.758102.44
5767583-76758398.44799.12
6764307-76430798.02798.69
60min1761650-76165097.68799.091.7298.5099.921.72
2765330-76533098.15998.99
3786024-786024100.813101.65
4792753-792753101.676102.53
5765898-76589898.23199.06
6763969-76396997.98498.81
极限1759605-75960597.42498.841.7598.4099.841.75
2763498-76349897.92498.91
3783815-783815100.529101.54
4791365-791365101.498102.52
5764492-76449298.05199.05
6761297-76129797.64198.63
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