比索洛尔氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
对照品批号100711-202203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2000
标示量(mg)5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%
110.118213882286824138222682265822660.13
210.158187282053819620.16
单位质量响应值RSD%判断
8137.098075.070.55数据可信
影响因素5天-供试品溶液-比索洛尔-0.005molhcl
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
20240301211906979078690742100.5598.802.4396.28%～101.31%
2914309162191526101.42
386747868108677896.16
4909549108291018100.85
587780879618787097.37
687067869938703096.44
2024030221188526885078851698.0899.582.4497.03%～102.13%
289198891948919698.84
3906069062390614100.41
4927009254192620102.63
586681865728662695.99
6914489178691617101.52
2024030321187932878508789197.3999.151.8197.27%～101.02%
287299872698728496.72
3913169132191318101.19
4909179094790932100.76
589538895348953699.21
689860899388989999.61
比索洛尔氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
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(%)99.9对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.521046791046131045671035041048131044350.51
213.491036961043861040410.47
单位质量响应值RSD%判断
7724.487712.450.12数据可信
影响因素5天-供试品溶液-氨氯地平-0.005molhcl
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024030121111035010969211002192.4095.592.0493.55%～97.64%
211288011293911291094.83
311481711538911510396.67
411310911324311317695.05
511526611490311508496.66
611703511621311662497.95
2024030221111816611899511858099.5998.032.9395.02%～101.04%
2120189121034120612101.30
311728611675011701898.28
411056911051611054292.84
511761811762711762298.79
611631811562611597297.40
2024030321111378411349111363895.4495.352.6492.71%～97.99%
211626411683011654797.88
310853510913110883391.41
411661811731111696498.23
511245711198511222194.25
611249111351511300394.91
比索洛尔氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
对照品批号100711-202203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2000
标示量(mg)5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%
110.118212981950820658197281990820210.10
210.158194481959819520.02
单位质量响应值RSD%判断
8112.868074.090.34数据可信
影响因素5天-供试品溶液-比索洛尔-0.005molhcl
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024030121189192892908924199.04100.061.5198.47%～101.64%
288890887538882298.57
3926579269492676102.85
489826898548984099.70
5905009048090490100.42
689862899318989699.77
2024030221185657856368564695.0595.983.6992.27%～99.69%
283747836818371492.90
3924269249592460102.61
483921839528393693.15
586818868858685296.39
686352862758631495.79
2024030321188894889778893698.7097.921.2896.61%～99.24%
289510895668953899.37
387580875668757397.19
488094880828808897.76
588827888958886198.62
686420864318642695.91
比索洛尔氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
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(%)99.9对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.521016441010191004531014801010471011290.46
213.491002841000831001840.15
单位质量响应值RSD%判断
7479.967426.540.51数据可信
影响因素5天-供试品溶液-氨氯地平-0.005molhcl
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024030121110677010690510683892.9297.923.2194.62%～101.21%
211404711380511392699.09
311387411415611401599.17
411085511079611082696.39
511194311261611228097.66
6117502117653117578102.27
2024030221110217310174010195688.6891.993.9488.18%～95.79%
210717510723010720293.24
311370111305211337698.61
410347310356310351890.04
510531110552510541891.69
610295510321610308689.66
2024030321110748810774410761693.6095.342.2893.06%～97.62%
211145711068011106896.60
310792010733710762893.61
411043011103811073496.31
510719110729210724293.28
611304411376111340298.63
比索洛尔氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
对照品批号100711-202203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2000
标示量(mg)5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%
110.118196982163820378208581962820430.11
210.158192781802818640.11
单位质量响应值RSD%判断
8115.038065.420.44数据可信
影响因素10天-供试品溶液-比索洛尔-0.005molhcl
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
20240301211908659088090872100.8999.162.1296.96%～101.36%
287198872978724896.87
388099881358811797.83
487496874518747497.12
5910669105391060101.10
6911019115291126101.17
20240302211900829015890120100.0599.472.9096.44%～102.50%
287020869118696696.55
3943819438594383104.79
488141881568814897.87
588355884038837998.12
689565895658956599.44
20240303211918859210391994102.14101.041.9998.94%～103.15%
288174882148819497.92
3927649275092757102.98
4924259222992327102.51
589403894258941499.27
6913679139591381101.45
比索洛尔氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
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(%)99.9对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.521035751035911030411040081033491035130.35
213.491038581034571036580.28
单位质量响应值RSD%判断
7656.297684.060.26数据可信
影响因素10天-供试品溶液-氨氯地平-0.005molhcl
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024030121110905610932310919092.2894.661.5793.10%～96.22%
211443511477211460496.86
311267711256811262295.18
411189711273711231794.93
511181411161411171494.42
611178311139111158794.31
2024030221110918810892410905692.1795.803.5292.27%～99.34%
2119331119920119626101.10
311206311231711219094.82
411259311244111251795.09
511014911032311023693.17
611654411645911650298.46
2024030321111263211330211296795.4896.322.9593.34%～99.30%
211523011528011525597.41
311408511350511379596.18
410841310870110855791.75
5118682119132118907100.50
611474511384511429596.60
比索洛尔氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
对照品批号100711-202203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2000
标示量(mg)5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%
110.118179782070818368208781896819370.17
210.158234882296823220.05
单位质量响应值RSD%判断
8104.558110.540.06数据可信
影响因素10天-供试品溶液-比索洛尔-0.005molhcl
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
20240301211928869263592760102.7699.441.9097.47%～101.42%
289032889978901498.61
388997888148890698.50
489033886558884498.43
588277882208824897.77
6908789072990804100.60
2024030221180855808728086489.5988.312.5485.96%～90.66%
282103820558207990.93
380090801678012888.77
480535804728050489.19
578258781737821686.65
676464764797647284.72
2024030321187527876318757997.0397.242.6494.55%～99.93%
2918609195991910101.82
388236883408828897.81
486546867268663695.98
584922850188497094.13
687287872438726596.68
比索洛尔氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
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(%)99.9对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.521010281003811001041008661007881006330.38
213.491006931015101011020.58
单位质量响应值RSD%判断
7443.277494.590.49数据可信
影响因素10天-供试品溶液-氨氯地平-0.005molhcl
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024030121111364711410211387498.8496.501.5994.89%～98.10%
211016710987411002095.49
310949610869710909694.69
411030711051511041195.83
511245611271211258497.72
611117311097411107496.41
2024030221110841010743210792193.6786.764.3982.77%～90.75%
210012510126610069687.40
397130968339698284.17
410099310082610091087.58
596662971359689884.10
696747960369639283.66
2024030321110481410464310472890.9091.031.7889.34%～92.72%
210196410214110205288.58
310540710538910539891.48
410350610364510357689.90
510652910636610644892.39
610693710723310708592.94
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