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%
127.935707875711865717155698605693065705710.18
228.055736935719495728210.22
单位质量响应值RSD%判断
20428.6120421.430.03数据可信
中间条件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
2024032421批163033162986863010049.9648.993.6747.10%～50.87%
260259860145160202447.74
361766661780561773648.98
464816564831664824051.40
562427062617962522449.58
658269758403558336646.26
2024032521批165928566052065990252.3348.893.7846.96%～50.83%
261559361610861585048.83
360773160633560703348.13
462050462127362088849.23
560097660221760159647.70
659517959375559446747.14
2024032621批166653966536866595452.8149.384.8246.89%～51.88%
260318160300060309047.82
362024962228862126849.26
458586058581758583846.45
565082164875264978651.52
661024161130661077448.43
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%
127.939849539836349853499837769821009839620.13
228.059884939876569880740.06
单位质量响应值RSD%判断
35229.5735225.450.01数据可信
中间条件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
2024032421批110804651078355107941046.8946.143.6244.39%～47.89%
210351021031560103333144.88
310630131063279106314646.18
411135181116545111503248.43
510740031079734107686846.78
610039411006729100533543.67
2024032521批111356611137354113650849.3746.053.9144.16%～47.94%
210602141060775106049446.06
310461941042957104457645.37
410658651067933106689946.34
510340941035583103483844.95
610177511017398101757444.20
2024032621批111489581146943114795049.8646.464.9244.07%～48.86%
210359221037011103646645.02
310652451068413106682946.34
410060841006132100610843.70
511145121114628111457048.41
610462321046286104625945.45
点击查看处理图标(自动生成)
　
原始图谱下载图谱(谢超君 于 2025-01-18 14:25:37 完成)
生成报告数据部分下载报告(谢超君 于 2025-01-18 14:26:57 完成)
Current page cost:39 ms