富马酸比索洛尔片项目信息
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100711-202203对照品来源中检所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%
19.878455184909848198428084518846150.30
29.868476784686847260.07
单位质量响应值RSD%判断
8572.958592.900.17数据可信
供试品溶液-1批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min192391-9239196.68794.702.6396.6994.702.63
288673-8867392.79692.80
387900-8790091.98791.99
493772-9377298.13298.13
591435-9143595.68795.69
688760-8876092.88792.89
10min193092-9309297.42197.062.1797.5897.212.17
294867-9486799.27899.43
391913-9191396.18796.34
494239-9423998.62198.78
593144-9314497.47597.63
689204-8920493.35293.51
15min193132-9313297.46296.942.3197.7997.262.31
294905-9490599.31899.64
391751-9175196.01796.33
494186-9418698.56598.89
592949-9294997.27197.59
688877-8887793.01093.32
20min192706-9270697.01796.562.1697.5097.042.15
294204-9420498.58499.07
391464-9146495.71796.19
493899-9389998.26598.76
592603-9260396.90997.39
688753-8875392.88093.35
30min192183-9218396.46996.072.1697.1296.712.16
293776-9377698.13698.79
391075-9107595.31095.94
493379-9337997.72198.38
592089-9208996.37197.02
688285-8828592.39093.01
45min192028-9202896.30795.672.7497.1296.472.73
293703-9370398.06098.87
390896-9089695.12295.91
493211-9321197.54598.36
591930-9193096.20597.01
686742-8674290.77591.55
极限191392-9139295.64295.152.3496.6196.112.33
292879-9287997.19898.17
389975-8997594.15995.11
492695-9269597.00597.99
591427-9142795.67896.64
687159-8715991.21292.14
富马酸比索洛尔片项目信息
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100711-202203对照品来源中检所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%
19.878482584831848948490784971848860.08
29.868413784680844080.46
单位质量响应值RSD%判断
8600.418560.650.33数据可信
供试品溶液-1批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min192748-9274897.08898.081.3397.0998.081.33
292263-9226396.58096.58
395275-9527599.73399.73
494525-9452598.94898.95
594557-9455798.98298.98
692809-9280997.15297.15
10min194798-9479899.23499.390.8799.4099.550.87
293632-9363298.01398.17
396012-96012100.505100.67
495625-95625100.100100.26
594705-9470599.13799.30
694900-9490099.34199.50
15min196136-96136100.63599.421.17100.9699.741.17
293068-9306897.42397.75
395836-95836100.321100.65
494730-9473099.16399.49
594613-9461399.04099.37
695452-9545299.919100.25
20min194197-9419798.60598.740.9599.1099.240.94
292796-9279697.13897.63
395223-9522399.679100.18
494616-9461699.04499.54
594041-9404198.44298.94
695111-9511199.562100.06
30min194256-9425698.66798.420.8499.3399.080.84
292597-9259796.93097.58
394896-9489699.337100.00
494085-9408598.48899.15
593810-9381098.20098.86
694490-9449098.91299.57
45min193470-9347097.84497.701.0598.6798.531.04
291708-9170895.99996.81
394537-9453798.96199.79
493155-9315597.51498.34
593092-9309297.44898.27
694058-9405898.45999.28
极限193312-9331297.67897.190.9798.6798.170.97
291195-9119595.46296.43
393874-9387498.26799.26
492940-9294097.28998.28
592726-9272697.06598.05
692999-9299997.35198.34
富马酸比索洛尔片项目信息
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100711-202203对照品来源中检所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%
19.878492184743851258486184941849180.17
29.868394383801838720.12
单位质量响应值RSD%判断
8603.658506.290.81数据可信
供试品溶液-2批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min193251-9325197.90997.271.2197.9197.271.21
293889-9388998.57998.58
393040-9304097.68797.69
490942-9094295.48595.48
591630-9163096.20796.21
693103-9310397.75497.75
10min194502-9450299.22298.301.1499.3998.461.14
295114-9511499.865100.03
393343-9334398.00698.17
492546-9254697.16997.33
592446-9244697.06497.22
693790-9379098.47598.64
15min194141-9414198.84398.111.1399.1798.431.13
294867-9486799.60699.94
393463-9346398.13298.46
492333-9233396.94597.27
592138-9213896.74097.06
693694-9369498.37498.70
20min194016-9401698.71297.811.1199.2198.301.11
294376-9437699.09099.59
393239-9323997.89698.39
491942-9194296.53597.02
591937-9193796.52997.01
693430-9343098.09798.59
30min193341-9334198.00397.621.2498.6698.271.24
294198-9419898.90399.57
394110-9411098.81199.46
491702-9170296.28396.93
591543-9154396.11696.76
692942-9294297.58498.24
45min192997-9299797.64296.931.0798.4697.741.07
293541-9354198.21399.04
392110-9211096.71197.53
491043-9104395.59196.39
591355-9135595.91896.72
692874-9287497.51398.33
极限192548-9254897.17196.221.1498.1597.201.14
292980-9298097.62498.61
391601-9160196.17697.16
490404-9040494.92095.88
590524-9052495.04696.01
691824-9182496.41197.39
富马酸比索洛尔片项目信息
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100711-202203对照品来源中检所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%
19.878442684615846168433984293844580.18
29.868451784367844420.13
单位质量响应值RSD%判断
8557.048564.100.06数据可信
供试品溶液-3批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min191520-9152096.02595.632.4696.0395.632.46
286965-8696591.24691.25
391304-9130495.79995.80
492802-9280297.37197.37
590968-9096895.44695.45
693300-9330097.89397.89
10min194109-9410998.74299.321.3098.9099.481.29
295671-95671100.381100.53
393358-9335897.95498.11
493731-9373198.34598.51
594539-9453999.19399.35
696558-96558101.311101.47
15min193975-9397598.60199.131.1598.9399.461.15
295686-95686100.397100.72
393293-9329397.88698.21
493853-9385398.47398.80
594125-9412598.75999.08
695968-95968100.692101.02
20min193507-9350798.11098.861.4698.6099.351.45
295788-95788100.504100.99
392936-9293697.51198.00
493205-9320597.79398.28
593789-9378998.40698.90
696095-96095100.826101.33
30min193095-9309597.67898.351.3898.3399.011.37
295525-95525100.228100.88
392342-9234296.88897.54
493297-9329797.89098.54
593024-9302497.60498.26
695153-9515399.837100.51
45min192620-9262097.18097.891.3797.9998.711.37
294903-9490399.575100.40
392096-9209696.63097.44
492713-9271397.27798.09
592505-9250597.05997.87
694946-9494699.620100.45
极限192067-9206796.59997.251.2597.5898.241.25
293957-9395798.58299.57
391237-9123795.72996.70
492129-9212996.66497.64
592567-9256797.12498.10
694189-9418998.82699.83
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