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%
114.746900016904966903816906886907086904550.05
214.796903736906656905190.03
单位质量响应值RSD%判断
46842.2746688.240.24数据可信
供试品溶液-24060302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%
5min1280904-28090434.85534.705.1534.8634.705.15
2286409-28640935.53935.54
3284170-28417035.26135.26
4253133-25313331.41031.41
5277627-27762734.44934.45
6295755-29575536.69836.70
10min1641739-64173979.62975.706.0579.6975.766.04
2595904-59590473.94274.00
3629486-62948678.10978.17
4541625-54162567.20767.26
5629335-62933578.09078.15
6622484-62248477.24077.30
15min1782156-78215697.05296.052.1797.2496.242.18
2772873-77287395.90096.08
3790378-79037898.07398.26
4744614-74461492.39492.56
5767624-76762495.24995.44
6786933-78693397.64597.83
20min1795806-79580698.74698.752.0699.1099.102.06
2815866-815866101.235101.58
3793662-79366298.48098.83
4782036-78203697.03797.36
5774682-77468296.12596.47
6813017-813017100.882101.23
30min1795189-79518998.67098.772.1499.1999.272.13
2816176-816176101.274101.78
3793606-79360698.47398.99
4784988-78498897.40497.88
5771870-77187095.77696.28
6813988-813988101.002101.52
45min1793757-79375798.49298.772.0399.1799.452.03
2813061-813061100.887101.57
3791389-79138998.19898.88
4785233-78523397.43498.08
5775535-77553596.23196.90
6817233-817233101.405102.09
极限1792618-79261898.35198.632.2699.2099.472.25
2816821-816821101.354102.20
3789747-78974797.99498.84
4784762-78476297.37698.18
5770446-77044695.59996.43
6814717-814717101.093101.95
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