培哚普利吲达帕胺片项目信息
介质体积(ml)500取样体积(ml)2补液体积(ml)2
对照品批号101072-202303对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数4000
标示量(mg)2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%
116.411633601633171631661631601633451632700.07
216.471633481630601632040.13
单位质量响应值RSD%判断
9949.429909.170.29数据可信
加速6月-供试品溶液-培哚普利-pH2.0(内含0.19%EDTA)
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
20231107211163384163017163200102.52101.231.2499.92%～102.55%
2160336160469160402100.76
3162201162096162148101.86
4160136160441160288100.69
5163014162840162927102.35
615778615810515794699.22
2023110821115327815318015322996.26100.052.7297.20%～102.90%
215463115439715451497.06
3161195161129161162101.24
4163795163916163856102.93
5161997162079162038101.79
6160649160986160818101.02
20231108221159648159675159662100.3099.642.3597.18%～102.10%
215574815522615548797.68
315333715333815333896.33
4163916164035163976103.01
5159906159848159877100.43
6159240159378159309100.08
培哚普利吲达帕胺片项目信息
介质体积(ml)500取样体积(ml)2补液体积(ml)2
对照品批号100275-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.2对照品水分(%)0对照品稀释倍数10000
标示量(mg)0.625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%
112.302950982947392949732950512950752949870.05
212.352949402947092948240.06
单位质量响应值RSD%判断
23982.6823872.390.33数据可信
加速6月-供试品溶液-吲达帕胺-pH2.0(内含0.19%EDTA)
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2023110721128261128220528240892.7293.901.1792.75%～95.05%
229073829071629072795.45
328632528563428598093.89
428890128864428877294.81
528577628559328568493.80
628239028251828245492.74
2023110821127550227573227561790.4992.102.8089.41%～94.80%
226985026945026965088.53
329146829130529138695.67
428102528102628102692.27
527862227843927853091.45
628697028696928697094.22
2023110822128948528937428943095.0394.273.1591.16%～97.38%
228719628659228689494.19
327198327185827192089.28
428442428438928440693.38
529958529925329941998.31
629076829045129061095.41
培哚普利吲达帕胺片项目信息
介质体积(ml)500取样体积(ml)2补液体积(ml)2
对照品批号101072-202303对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数4000
标示量(mg)2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%
116.411627501627351629801626141627511627660.09
216.471621071621651621360.03
单位质量响应值RSD%判断
9918.719844.320.54数据可信
长期6月-供试品溶液-培哚普利-pH2.0(内含0.19%EDTA)
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2023110721115723315743915733699.32100.440.7799.64%～101.25%
2160111159997160054101.03
315786715812015799499.73
4159409159045159227100.51
5159697159691159694100.80
6160452160455160454101.28
20231108211162395162251162323102.46100.451.8598.51%～102.39%
215588115605015596698.45
3161753161518161636102.03
415767615758515763099.50
5161322161182161252101.79
615594815603315599098.47
20231108221158754158905158830100.26101.231.4799.67%～102.79%
2159205159331159268100.54
3162521162436162478102.56
415691315808415749899.42
5163819163694163756103.37
6160286160527160406101.25
培哚普利吲达帕胺片项目信息
介质体积(ml)500取样体积(ml)2补液体积(ml)2
对照品批号100275-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.2对照品水分(%)0对照品稀释倍数10000
标示量(mg)0.625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%
112.302950422952062948382946132949082949210.08
212.352939252939622939440.01
单位质量响应值RSD%判断
23977.3223801.130.53数据可信
长期6月-供试品溶液-吲达帕胺-pH2.0(内含0.19%EDTA)
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2023110721128852128856928854594.8993.721.0592.69%～94.76%
228637728626628632294.16
327974927990627982892.02
428424528427628426093.48
528665428661328663494.26
628457128429328443293.54
2023110821128099528067028083292.3592.491.9090.66%～94.33%
227175427231927203689.46
328515128514328514793.77
428735528727528731594.49
528275228251028263192.94
627959127961927960591.95
2023110822128888928857728873394.9595.044.7990.27%～99.80%
227403827390127397090.10
329484829503429494196.99
427712427724827718691.15
528695028643428669294.28
6312463312377312420102.74
点击查看处理图标(自动生成)
　
原始图谱下载图谱(谢鑫慧 于 2024-05-22 17:24:37 完成)
生成报告数据部分下载报告(谢鑫慧 于 2024-05-22 17:25:26 完成)
Current page cost:75 ms