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%
114.796787346788096791736789646793796790120.04
214.846770016778066774040.09
单位质量响应值RSD%判断
45910.2145647.170.41数据可信
供试品溶液-H043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%
5min1224870-22487028.50427.699.8028.5027.699.80
2244473-24447330.98930.99
3216455-21645527.43727.44
4234444-23444429.71829.72
5184508-18450823.38823.39
6205882-20588226.09726.10
10min1580040-58004073.52571.843.8573.5771.883.85
2586552-58655274.35074.40
3557600-55760070.68070.73
4587376-58737674.45574.50
5532303-53230367.47467.51
6556430-55643070.53270.58
15min1786381-78638199.68098.652.7199.8598.822.72
2786148-78614899.65099.83
3769405-76940597.52897.69
4810429-810429102.728102.90
5748312-74831294.85495.01
6769092-76909297.48897.65
20min1801043-801043101.539102.231.83101.87102.561.83
2802459-802459101.718102.06
3792912-792912100.508100.83
4835263-835263105.876106.22
5802063-802063101.668101.98
6805469-805469102.100102.42
30min1800806-800806101.508102.121.93102.01102.621.93
2798973-798973101.276101.79
3791844-791844100.372100.87
4836068-836068105.978106.50
5802790-802790101.760102.24
6803097-803097101.799102.29
45min1795319-795319100.813101.771.77101.49102.441.77
2796205-796205100.925101.61
3790582-790582100.213100.87
4830025-830025105.212105.91
5799540-799540101.348102.00
6805636-805636102.121102.78
极限1795879-795879100.884101.711.81101.73102.551.81
2795291-795291100.809101.66
3789730-789730100.105100.93
4830519-830519105.275106.15
5799850-799850101.387102.20
6803053-803053101.793102.63
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%
114.796779416788576787716788786796136788120.09
214.846802266799796801020.03
单位质量响应值RSD%判断
45896.6945828.980.11数据可信
供试品溶液-H043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%
5min1245435-24543531.05429.0714.1131.0529.0714.11
2250942-25094231.75031.75
3201414-20141425.48425.48
4258984-25898432.76832.77
5243984-24398430.87030.87
6177816-17781622.49822.50
10min1588037-58803774.40172.225.0174.4572.275.02
2587970-58797074.39374.45
3546980-54698069.20669.25
4596069-59606975.41775.47
5581512-58151273.57573.63
6524152-52415266.31866.36
15min1789908-78990899.94398.192.38100.1298.362.39
2779859-77985998.67198.85
3755609-75560995.60395.76
4792106-792106100.221100.40
5788398-78839899.75299.93
6750325-75032594.93495.08
20min1802426-802426101.526101.451.06101.87101.781.06
2798028-798028100.970101.31
3791239-791239100.111100.43
4816962-816962103.366103.71
5800536-800536101.287101.63
6801629-801629101.426101.73
30min1800473-800473101.279101.510.91101.79102.010.91
2799206-799206101.119101.63
3793281-793281100.369100.85
4813291-813291102.901103.42
5799035-799035101.097101.61
6808315-808315102.272102.75
45min1800708-800708101.309101.220.95101.99101.890.96
2796834-796834100.819101.50
3789770-78977099.925100.58
4813059-813059102.872103.56
5800427-800427101.274101.95
6799140-799140101.111101.76
极限1801431-801431101.401101.030.94102.25101.860.95
2797692-797692100.927101.77
3788172-78817299.723100.54
4810653-810653102.567103.43
5798234-798234100.996101.84
6794656-794656100.543101.36
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