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%
110.118207982138820508222982217821430.10
210.158221381989821010.20
单位质量响应值RSD%判断
8124.938088.770.32数据可信
加速3月-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
2024021621186616866138661495.9698.712.3296.31%～101.11%
289160891698916498.79
389201891808919098.82
488656886438865098.22
5928329281492823102.84
688130881068811897.63
2024021821189237892218922998.8699.721.8097.84%～101.60%
2918069188391844101.76
390137901309013499.86
4919769199591986101.92
588664886168864098.21
688172882228819797.72
20240220211912779126891272101.1399.182.3296.76%～101.59%
288152881138813297.65
3921209214192130102.08
487166871678716696.58
5906099054790578100.36
687778877798777897.25
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%
113.521031631037101039151035711035871035890.27
213.491033391031541032460.13
单位质量响应值RSD%判断
7661.917653.520.08数据可信
加速3月-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
2024021621111528311530211529297.6094.082.7091.41%～96.75%
210962010973910968092.85
311246511293011269895.40
411270511346511308595.73
510810010758710784491.29
610823410819510821491.61
2024021821111162111144711153494.4296.283.2493.01%～99.56%
211181811134911158494.46
3120215119846120030101.61
411617111594811606098.25
511034110995411014893.24
611283211334211308795.73
2024022021111169211152211160794.4895.402.3393.08%～97.72%
211501011414611457896.99
310893510906110899892.27
411506011505111505697.40
511081011064611072893.73
611464511578611521697.53
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%
110.118231682262822968237182345823180.06
210.158182981931818800.09
单位质量响应值RSD%判断
8142.248067.000.66数据可信
长期3月-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
2024021621189724898008976299.4899.562.5296.94%～102.19%
289140889828906198.70
388525884848850498.09
4916539169191672101.60
5931459316393154103.24
686866868858687696.28
20240218211919169182291869101.82101.701.9799.60%～103.79%
2945609462594592104.83
389216891638919098.85
4906219066490642100.46
5922459237692310102.31
6919949188991942101.90
2024022021184259842308424493.3798.563.3595.10%～102.03%
2912569130191278101.16
386575865218654895.92
4918739217292022101.99
590146900889011799.87
689373894308940299.08
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%
113.521035151040681038701040951038181038730.23
213.491027631030381029000.19
单位质量响应值RSD%判断
7682.917627.870.51数据可信
长期3月-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
2024021621111410911413911412496.6495.251.6993.56%～96.93%
211308011228311268295.42
311160211206111183294.70
410982510973410978092.96
511539811465611502797.40
611190711096111143494.36
20240218211118816118406118611100.4497.803.5994.12%～101.49%
210845610940310893092.24
311225411219711222695.03
411604411544511574498.01
5119553119398119476101.17
611801111803411802299.94
2024022021111224311194411209494.9295.071.8493.24%～96.90%
211317711312611315295.82
311505111534611519897.55
411242311273811258095.33
510882510893610888092.20
611161911183411172694.61
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%
110.118170481925819098176681708818020.14
210.158273282888828100.14
单位质量响应值RSD%判断
8091.208158.620.59数据可信
中间条件3月-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
20240216211920439213092086101.80100.073.1196.80%～103.33%
2923599232692342102.08
385757857908577494.82
490034900399003699.54
589222893178927098.69
6936019358793594103.47
20240218211919059203391969101.67100.712.5897.99%～103.44%
289929900869000899.50
388337884018836997.69
4934789353093504103.37
5937799392393851103.75
688892889408891698.30
2024022021189560893828947198.9198.871.0697.78%～99.96%
2907099074790728100.30
389022889268897498.36
488119881588813897.44
589033890418903798.43
690257902709026499.79
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%
113.521028771029971025091024091025121026610.26
213.491043711045641044680.14
单位质量响应值RSD%判断
7593.277744.111.40数据可信
中间条件3月-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
2024021621110994911051511023293.1995.353.1492.22%～98.49%
210734110685610709890.54
311599311619311609398.15
411565011604111584697.94
511436611476411456596.85
611265911313311289695.44
2024021821111545011537011541097.5796.611.8394.76%～98.46%
211252211301511276895.33
311768611803011785899.64
411270611299111284895.40
511225511268811247295.08
611433511429911431796.64
2024022021111154711175411165094.3993.911.7792.17%～95.65%
210894610915710905292.19
310862410810810836691.61
411171911243511207794.75
511185411186311185894.57
611363011333811348495.94
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