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%
116.293869639275388583899739305390260.68
216.333987240011399420.25
单位质量响应值RSD%判断
2395.702445.931.47数据可信
影响因素10天-供试品溶液-含0.35%吐温20的pH6.8
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2025030321批139431393693940091.3892.231.3090.98%~93.48%
239187389903908890.65
339727394883960891.86
439882400363995992.67
540417406744054694.03
639451405504000092.77
2025030121批141193411634117895.5096.160.9495.22%~97.11%
241598416104160496.49
341362413764136995.94
440519412854090294.86
542349415004192497.23
642230413894181096.97
2025030121批141773423284205097.5295.871.4094.47%~97.28%
241982415384176096.85
341803411214146296.16
441033412064112095.37
541389411104125095.67
640760400134038693.66
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%
116.297851177680782057777978475781300.50
216.337790677462776840.41
单位质量响应值RSD%判断
4796.194757.130.58数据可信
影响因素10天-供试品溶液
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2025030321批185670828168424399.0196.741.8494.87%~98.60%
284533822518339298.01
382840838348333797.94
480988810418101495.21
581214807728099395.19
681256805178088695.06
2025030121批180240812158072894.8894.620.3794.26%~94.97%
280943793208013294.18
380777795888018294.24
480075808808047894.58
580803805828069294.83
681448801778081294.98
2025030121批180820810688094495.1394.591.3193.29%~95.88%
280751823858156895.86
381731816608169696.01
479890796397976493.74
579987786677932793.23
678847803527960093.55
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%
116.297854978219782507900177754783550.59
216.337871478910788120.18
单位质量响应值RSD%判断
4810.014826.210.24数据可信
影响因素10天-供试品溶液
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2025030321批177548788097817891.0992.621.3591.31%~93.92%
280141790077957492.71
380701801038040293.68
478420781897830491.24
581067805438080594.15
680087792517966992.83
2025030121批179623790407933292.4392.711.0591.70%~93.72%
279169793907928092.37
380569799348025293.50
480462810798077094.11
578158786477840291.35
679801789707938692.50
2025030121批179347803147983093.0193.561.1592.43%~94.68%
279927795717974992.92
381695808598127794.70
481721813688154495.01
580099802588017893.42
679257791547920692.29
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