阿齐沙坦氨氯地平片项目信息
介质体积(ml) 900 取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.75对照品水分(%)0对照品稀释倍数1000
标示量(mg)20供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.842807132807492807152807582808262807520.02
210.982803232802192802710.03
单位质量响应值RSD%判断
25899.6325525.591.03数据可信
供试品溶液-阿齐沙坦-pH6.8
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024030121126635226659626647493.0493.913.7590.22%~97.60%
226103926084626094291.11
328269428265628267598.70
427028627039427034094.39
525580125578925579589.31
627751127756727753996.91
2024030221127822527802927812797.1196.881.7595.11%~98.66%
227884227900627892497.39
327002327015727009094.31
427711627693327702496.73
527558427569727564096.24
628532028480728506499.53
2024030321125902525867725885190.3893.403.9389.56%~97.25%
227298927274127286595.28
327127027135927131494.73
425283025278525280888.27
528212428233228222898.54
626699526696926698293.22
阿齐沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml) 5补液体积(ml) 5
对照品批号100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%) 99.90对照品水分(%)0对照品稀释倍数4000
标示量(mg)5供试品稀释倍数2系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.697177371833718917181471851718320.07
214.717174771600716740.15
单位质量响应值RSD%判断
4889.864872.470.26数据可信
供试品溶液-氨氯地平-pH6.8
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024030121169498695146950692.3293.592.1991.44%~95.73%
268628686996866491.20
372775731337295496.90
469736696486969292.57
570616704897055293.71
671459713107138494.82
2024030221167773676236769889.9294.832.9191.93%~97.72%
270075703037018993.23
373076728507296396.91
472644728277273696.61
572076720217204895.70
672624728167272096.59
2024030321169524696126956892.4095.122.6392.50%~97.75%
273225735077336697.45
371624715647159495.10
471504714787149194.96
574099741297411498.44
669584695406956292.40
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