坎地沙坦酯片项目信息
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100685-201903对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)8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%
116.067913779053790477904379195790950.09
2 16.247940878747790780.60
单位质量响应值RSD%判断
4924.974869.330.81数据可信
供试品溶液-2025022821批-pH1.2(内含0.5%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11551-15511.7782.1118.521.782.1118.48
21962-19622.2492.25
31687-16871.9341.93
41784-17842.0452.05
52469-24692.8302.83
61594-15941.8271.83
10min16243-62437.1577.545.547.167.555.54
26828-68287.8277.83
36469-64697.4167.42
46400-64007.3377.34
57202-72028.2568.26
66340-63407.2687.27
15min112074-1207413.84113.893.8913.8613.913.87
212315-1231514.11814.13
311838-1183813.57113.59
412464-1246414.28814.30
512658-1265814.51114.53
611358-1135813.02013.04
20min117300-1730019.83221.025.3019.8721.065.30
218939-1893921.71121.75
318375-1837521.06421.10
419592-1959222.46022.50
518722-1872221.46221.50
617095-1709519.59719.63
30min127695-2769531.74932.522.4031.8232.592.41
228687-2868732.88632.96
327894-2789431.97732.05
429024-2902433.27233.35
529192-2919233.46533.54
627714-2771431.77031.84
45min137726-3772643.24843.811.3343.3743.941.34
238513-3851344.15044.28
337986-3798643.54643.67
438769-3876944.44344.58
538691-3869144.35444.49
637614-3761443.11943.24
60min144285-4428550.76752.011.7150.9652.211.71
245493-4549352.15252.36
344890-4489051.46051.66
446003-4600352.73652.94
546414-4641453.20753.42
645111-4511151.71451.91
极限149469-4946956.71057.531.1256.9957.821.13
250278-5027857.63757.93
350012-5001257.33257.62
450964-5096458.42358.72
550641-5064158.05358.35
649740-4974057.02057.30
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