苯磺酸美洛加巴林片项目信息
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D405-1-240701对照品来源原料对照品使用方法直接使用
对照品含量(%)99.66对照品水分(%)0.00对照品稀释倍数4000
标示量(mg)2.5供试品稀释倍数1系数0.5695
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
119.419667896670965389666696667966440.07
219.459678596839968120.04
单位质量响应值RSD%判断
4979.084977.480.03数据可信
中间条件6月-供试品溶液-2025042321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%
5min199266-99266101.854101.291.32101.85101.291.32
2100708-100708103.334103.33
397141-9714199.67499.67
499350-99350101.940101.94
597866-97866100.418100.42
697954-97954100.508100.51
10min1100627-100627103.251102.121.27103.42102.281.27
2100985-100985103.618103.79
397729-97729100.277100.44
4100130-100130102.741102.91
598857-98857101.434101.60
698796-98796101.372101.54
15min1100319-100319102.934101.881.26103.28102.221.26
2100829-100829103.458103.80
397587-97587100.131100.46
499879-99879102.483102.82
598560-98560101.130101.47
698572-98572101.142101.48
20min1100200-100200102.812101.751.18103.33102.261.18
2100676-100676103.301103.82
397720-97720100.268100.77
499600-99600102.197102.71
598316-98316100.879101.38
698504-98504101.072101.58
30min1100082-100082102.691102.040.99103.38102.720.99
2100482-100482103.102103.79
397973-97973100.527101.19
4100256-100256102.870103.55
598842-98842101.419102.09
699072-99072101.655102.33
45min1100235-100235102.848101.731.23103.70102.571.23
2100546-100546103.167104.03
397440-9744099.980100.82
499731-99731102.331103.18
598561-98561101.131101.97
698331-98331100.895101.74
极限1100029-100029102.637101.671.21103.66102.691.21
2100620-100620103.243104.28
397673-97673100.219101.22
499672-99672102.271103.29
598575-98575101.145102.16
697973-97973100.527101.54
苯磺酸美洛加巴林片项目信息
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D405-1-240701对照品来源原料对照品使用方法直接使用
对照品含量(%)99.66对照品水分(%)0.00对照品稀释倍数4000
标示量(mg)2.5供试品稀释倍数1系数0.5695
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
119.419682997008970269673597075969350.15
219.459692296913969180.01
单位质量响应值RSD%判断
4994.084982.930.16数据可信
中间条件6月-供试品溶液-2025042322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%
5min194424-9442496.687100.552.1996.69100.552.19
298502-98502100.863100.86
3100638-100638103.050103.05
499032-99032101.406101.41
599300-99300101.680101.68
697269-9726999.60199.60
10min195044-9504497.322101.542.2897.48101.702.29
299310-99310101.691101.86
3101335-101335103.764103.94
4100659-100659103.072103.24
5100184-100184102.585102.75
698428-98428100.787100.95
15min194817-9481797.090101.302.3097.41101.632.30
298965-98965101.337101.67
3101403-101403103.834104.18
4100063-100063102.462102.80
599949-99949102.345102.69
698346-98346100.703101.04
20min194744-9474497.015101.262.3597.50101.762.35
299039-99039101.413101.92
3101198-101198103.624104.14
4100443-100443102.851103.36
599944-99944102.340102.85
697962-97962100.310100.81
30min194548-9454896.814101.052.3197.46101.722.31
299081-99081101.456102.13
3100795-100795103.211103.90
4100132-100132102.532103.22
599764-99764102.155102.84
697770-97770100.114100.78
45min194234-9423496.493100.872.3897.30101.712.38
298702-98702101.068101.91
3100950-100950103.370104.23
499900-99900102.295103.15
599358-99358101.740102.59
697892-97892100.239101.07
极限194314-9431496.575100.832.3897.54101.842.38
298724-98724101.090102.10
3100905-100905103.324104.36
4100063-100063102.462103.49
599249-99249101.628102.65
697537-9753799.875100.88
苯磺酸美洛加巴林片项目信息
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D405-1-240701对照品来源原料对照品使用方法直接使用
对照品含量(%)99.66对照品水分(%)0.00对照品稀释倍数4000
标示量(mg)2.5供试品稀释倍数1系数0.5695
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
119.419708696961970289659197009969350.21
219.459706696831969480.18
单位质量响应值RSD%判断
4994.084984.470.14数据可信
中间条件6月-供试品溶液-2025042421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%
5min194352-9435296.59998.642.3896.6098.642.38
296095-9609598.38398.38
397067-9706799.37899.38
493297-9329795.51995.52
597703-97703100.029100.03
699574-99574101.945101.95
10min195402-9540297.67499.181.9697.8399.341.96
296620-9662098.92199.08
397911-97911100.242100.41
493989-9398996.22796.39
598521-98521100.867101.03
698783-98783101.135101.31
15min195462-9546297.73599.302.2298.0699.632.22
296748-9674899.05299.38
397349-9734999.667100.00
493912-9391296.14896.47
598581-98581100.928101.26
699915-99915102.294102.63
20min195058-9505897.32299.072.2297.8199.562.22
296516-9651698.81499.31
397012-9701299.32299.82
493836-9383696.07096.55
598456-98456100.800101.30
699690-99690102.064102.57
30min195046-9504697.30999.162.3597.9699.822.35
296562-9656298.86199.52
397510-9751099.832100.50
493739-9373995.97196.61
598213-98213100.552101.22
6100079-100079102.462103.14
45min194842-9484297.10098.882.3397.9199.712.34
296298-9629898.59199.41
397226-9722699.541100.37
493419-9341995.64396.44
597994-97994100.327101.17
699711-99711102.085102.94
极限194640-9464096.89498.562.2697.8799.552.26
295904-9590498.18899.18
396958-9695899.267100.26
493155-9315595.37396.33
597806-97806100.135101.14
699127-99127101.487102.51
苯磺酸美洛加巴林片项目信息
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D405-1-240701对照品来源原料对照品使用方法直接使用
对照品含量(%)99.66对照品水分(%)0.00对照品稀释倍数4000
标示量(mg)2.5供试品稀释倍数1系数0.5695
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
119.419698597116966299685696483968140.27
219.459683296901968660.06
单位质量响应值RSD%判断
4987.844980.260.11数据可信
中间条件6月-供试品溶液-YAB2147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%
5min193292-9329295.61489.1710.7595.6189.1710.76
288079-8807990.27190.27
385952-8595288.09188.09
468946-6894670.66270.66
593365-9336595.68895.69
692388-9238894.68794.69
10min1100864-100864103.374102.441.40103.53102.581.40
299310-99310101.781101.93
399197-99197101.665101.81
498998-98998101.462101.58
598952-98952101.414101.57
6102388-102388104.936105.09
15min1100434-100434102.933102.631.54103.26102.941.53
299350-99350101.822102.14
399304-99304101.775102.09
499839-99839102.323102.61
598825-98825101.284101.61
6103057-103057105.622105.95
20min199788-99788102.271102.361.69102.77102.851.69
299131-99131101.598102.09
399111-99111101.577102.06
499555-99555102.032102.49
598477-98477100.928101.42
6103186-103186105.754106.26
30min1100096-100096102.587102.281.85103.26102.941.85
298620-98620101.074101.73
398916-98916101.378102.03
499573-99573102.051102.68
598253-98253100.698101.36
6103293-103293105.863106.55
45min199983-99983102.471102.001.58103.32102.831.58
298727-98727101.184102.01
398434-98434100.884101.71
498928-98928101.390102.19
598527-98527100.979101.81
6102511-102511105.062105.92
极限199904-99904102.390101.701.88103.41102.701.89
297676-97676100.107101.10
398295-98295100.741101.73
498599-98599101.053102.02
598208-98208100.652101.65
6102723-102723105.279106.32
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