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500
标示量(mg)20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%
114.516600406607886611856612826612386609070.08
214.546602546617616610080.17
单位质量响应值RSD%判断
45548.3845461.350.14数据可信
供试品溶液-2024090521-9M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%
5min1275646-27564635.15034.446.0235.1534.446.02
2262688-26268833.49833.50
3280509-28050935.77035.77
4291674-29167437.19437.19
5244931-24493131.23431.23
6264836-26483633.77233.77
10min1532064-53206467.84967.594.0767.9167.654.07
2522919-52291966.68266.74
3543266-54326669.27769.34
4555051-55505170.78070.84
5492035-49203562.74462.80
6534757-53475768.19268.25
15min1692010-69201088.24588.863.1788.4289.023.17
2686524-68652487.54587.71
3707863-70786390.26690.44
4727996-72799692.83493.01
5662794-66279484.51984.68
6703591-70359189.72289.89
20min1775842-77584298.93598.991.1999.2599.311.20
2765197-76519797.57897.89
3779864-77986499.44899.77
4788325-788325100.527100.86
5765985-76598597.67897.98
6782408-78240899.772100.09
30min1790955-790955100.862101.020.43101.35101.500.43
2786537-786537100.299100.77
3794428-794428101.305101.80
4796100-796100101.518102.02
5793460-793460101.182101.64
6791641-791641100.950101.44
45min1784037-78403799.980100.590.46100.63101.240.47
2784768-784768100.073100.72
3792371-792371101.043101.70
4792097-792097101.008101.68
5789427-789427100.668101.30
6790366-790366100.787101.44
极限1784888-784888100.089100.420.49100.91101.240.49
2780867-78086799.576100.39
3789321-789321100.654101.48
4791112-791112100.882101.72
5789216-789216100.641101.44
6789390-789390100.663101.48
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