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%
128.271143354114329211422561142653114273911428590.05
228.321142772114394611433590.08
单位质量响应值RSD%判断
40426.5740372.850.10数据可信
加速3月-供试品溶液-缬沙坦钠-pH6.8
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024030121112984191299372129889652.0750.484.7147.99%～52.98%
213061261305488130580752.35
312997691300574130017252.12
411717691172236117200246.98
512824871283074128278051.43
611958151196140119597847.95
2024030221111620031162731116236746.6048.745.9345.71%～51.76%
211487841148857114882046.06
313132921312933131311252.64
411919431191815119187947.78
512996731300738130020652.12
611780501177027117753847.21
2024030321112827271284527128362751.4649.057.9044.99%～53.11%
210851451084133108463943.48
312516821252312125199750.19
411191241119879111950244.88
513104181310772131059552.54
612905531291003129077851.75
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%
128.271986261198607019846851985859198543819856630.04
228.321987050198878819879190.07
单位质量响应值RSD%判断
70239.2370194.880.05数据可信
加速3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
2024030121122547362256110225542349.1547.614.8245.20%～50.01%
222670632266698226688049.40
322575262258816225817149.21
420295222030143202983244.23
522245052225006222475648.48
620721322072996207256445.17
2024030221120119382013224201258143.8645.936.1842.96%～48.90%
219874731987377198742543.31
322848292284491228466049.79
420648602064039206445044.99
522581182259732225892549.23
620380502036755203740244.40
2024030321122289812230879222993048.5946.228.1042.30%～50.15%
218751501873253187420240.84
321738822174872217437747.38
419347091936092193540042.18
522734252274158227379249.55
622395762240361223996848.81
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%
128.271143382114391711435841143869114373111436970.02
228.321149339114981311495760.03
单位质量响应值RSD%判断
40456.2140592.370.24数据可信
长期3月-供试品溶液-缬沙坦钠-pH6.8
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024030121113372931337940133761653.4649.457.6445.49%～53.41%
212813531282630128199251.24
311136621114017111384044.52
411242341125125112468044.95
512985881298472129853051.90
612671031266240126667250.62
2024030221112215441221717122163048.8246.896.3043.79%～49.99%
211457141146274114599445.80
311243261124299112431244.93
410958041095642109572343.79
512977401297209129747451.86
611544141154887115465046.15
2024030321113129901313427131320852.4849.916.1746.68%～53.14%
211963261196766119654647.82
311154571115246111535244.58
412879291287858128789451.47
512968451296853129684951.83
612828421282906128287451.27
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%
128.271987267198761319869271987590198673919872270.02
228.321997352199845219979020.04
单位质量响应值RSD%判断
70294.5570547.390.26数据可信
长期3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
2024030121123229042323413232315850.4846.637.7042.86%～50.39%
222211492223460222230448.29
319303541930969193066241.95
419482551950083194916942.35
522532792253297225328848.96
621970342195788219641147.73
2024030221121208532120984212091846.0944.196.3941.23%～47.15%
219792071981235198022143.03
319536941952829195326242.44
418986491898074189836241.25
522528292251991225241048.94
619966041997985199729443.40
2024030321122831722283602228338749.6247.116.2744.01%～50.21%
220769782077205207709245.13
319325131932127193232041.99
422337552233586223367048.54
522518812251722225180248.93
622300992230384223024248.46
点击查看处理图标(自动生成)
　
原始图谱下载图谱(谢鑫慧 于 2024-07-16 11:48:41 完成)
生成报告数据部分下载报告(谢鑫慧 于 2024-07-16 11:50:53 完成)
Current page cost:48 ms