恩格列净片项目信息
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DC033-12306002对照品来源分装对照品使用方法直接使用
对照品含量(%)98.99对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.80 5481925476585469765465175459525470590.17
29.825447515445475446490.03
单位质量响应值RSD%判断
55822.3555463.240.46数据可信
加速6月-供试品溶液-23121802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%
5min1377694-37769460.47474.4613.2360.4774.4613.23
2432210-43221069.20369.20
3514507-51450782.38082.38
4525697-52569784.17184.17
5425234-42523468.08668.09
6515073-51507382.47082.47
10min1537746-53774686.10191.843.9386.2091.973.94
2559907-55990789.64989.76
3582454-58245493.25993.40
4601329-60132996.28196.42
5572103-57210391.60291.72
6588152-58815294.17194.31
15min1587857-58785794.12496.012.0594.3796.282.06
2589044-58904494.31494.58
3592910-59291094.93395.23
4619366-61936699.16999.47
5607919-60791997.33697.60
6600547-60054796.15696.45
20min1611804-61180497.95897.561.6898.3698.001.68
2600433-60043396.13896.56
3598365-59836595.80796.26
4624249-62424999.951100.42
5617286-61728698.83699.26
6603888-60388896.69197.15
30min1627091-627091100.40698.751.66100.9799.351.65
2612385-61238598.05198.63
3603560-60356096.63897.25
4628281-628281100.597101.23
5620970-62097099.426100.02
6608259-60825997.39198.01
45min1631585-631585101.12699.581.53101.86100.341.51
2624347-62434799.967100.71
3609225-60922597.54598.32
4630468-630468100.947101.75
5624518-62451899.994100.75
6611455-61145597.90398.68
60min1634208-634208101.54699.961.53102.45100.891.51
2630205-630205100.905101.82
3612295-61229598.03798.97
4631190-631190101.062102.03
5624822-624822100.043100.97
6613021-61302198.15399.09
极限1644214-644214103.148101.621.15104.22102.721.13
2636616-636616101.931103.01
3626801-626801100.360101.46
4641531-641531102.718103.86
5628138-628138100.574101.67
6630636-630636100.974102.08
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