沙库巴曲缬沙坦钠片项目信息
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DSMF-4022-230920对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.85对照品水分(%)5.54对照品稀释倍数500
标示量(mg)50供试品稀释倍数1系数0.47699
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
127.935701385695115704285707605707385703150.10
228.055694605680695687640.18
单位质量响应值RSD%判断
20419.4420276.790.50数据可信
长期9月-供试品溶液-缬沙坦-pH6.8
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024032721批165386265351965369052.0349.093.5247.28%～50.90%
261794061800861797449.19
359745459549959647647.48
462560162542062551049.79
559475659514259494947.36
661159261240661199948.71
2024032821批161645661622461634049.0648.972.5747.65%～50.29%
262789662785862787749.98
362506462380762443649.70
462976662836962906850.07
558877958883258880646.87
660484760427860456248.12
2024032921批160551460384560468048.1350.362.9848.79%～51.93%
265181765227765204751.90
363265563250163257850.35
465617865445365531652.16
562746362789362767849.96
662344262426262385249.66
沙库巴曲缬沙坦钠片项目信息
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DSMF-4022-230920对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.85对照品水分(%)5.54对照品稀释倍数500
标示量(mg)50供试品稀释倍数1系数0.45065
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
127.939850809843729853259853099847079849590.05
228.059820869824769822810.03
单位质量响应值RSD%判断
35265.2735018.930.50数据可信
长期9月-供试品溶液-沙库巴曲-pH6.8
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024032721批111302801132134113120749.2646.443.5244.73%～48.15%
210700161068028106902246.55
310321201030052103108644.90
410780151080201107910846.99
510297121030346103002944.85
610573551059162105825846.08
2024032821批110663021064454106537846.3946.242.6644.96%～47.53%
210849441085159108505247.25
310810871078198107964247.01
410854201083870108464547.23
510141991016145101517244.20
610425831041931104225745.38
2024032921批110405911041391104099145.3347.403.0845.87%～48.93%
211217211124789112325548.91
310881171087560108783847.37
411300611129327112969449.19
510796601082459108106047.07
610697371067611106867446.53
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