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2000
标示量(mg)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%
119.561019121020841021661017861024801020860.27
219.491017821019891018860.15
单位质量响应值RSD%判断
5219.125227.600.12数据可信
供试品溶液-2025042321批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1102778-102778100.51098.112.45100.5198.122.45
297815-9781595.65695.66
3101964-10196499.71499.71
4101171-10117198.93898.94
596730-9673094.59594.60
6101512-10151299.27299.27
10min1105732-105732103.398100.901.64103.57101.061.64
2100533-10053398.31498.47
3103792-103792101.501101.67
4102792-102792100.523100.69
5102829-102829100.559100.72
6103387-103387101.105101.27
15min1105797-105797103.462100.762.14103.80101.092.14
299121-9912196.93397.26
3103721-103721101.432101.77
4102534-102534100.271100.60
5103658-103658101.370101.70
6103380-103380101.098101.43
20min1105763-105763103.429100.662.09103.94101.162.08
299320-9932097.12897.61
3103394-103394101.112101.62
4102189-10218999.934100.43
5103981-103981101.686102.18
6102963-102963100.690101.19
30min1105212-105212102.890100.492.03103.57101.162.03
299024-9902496.83897.49
3103411-103411101.129101.80
4102224-10222499.968100.63
5103742-103742101.452102.12
6102945-102945100.673101.34
45min1105568-105568103.238100.482.19104.09101.322.19
298807-9880796.62697.43
3103165-103165100.888101.73
4102048-10204899.796100.63
5103609-103609101.322102.16
6103297-103297101.017101.86
极限1105492-105492103.164100.162.14104.19101.162.14
298775-9877596.59597.56
3102563-102563100.299101.31
4101944-10194499.694100.69
5103415-103415101.133102.13
6102351-102351100.092101.10
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2000
标示量(mg)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%
119.561020891025641026041024141021471023640.24
219.491024881022691023780.16
单位质量响应值RSD%判断
5233.335252.850.27数据可信
供试品溶液-2025042321批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1104341-104341101.654100.062.88101.65100.062.88
297084-9708494.58494.58
3105307-105307102.596102.60
4102193-10219399.56299.56
5104115-104115101.434101.43
6103181-103181100.524100.52
10min1105218-105218102.509101.432.78102.68101.602.78
298741-9874196.19996.36
3106980-106980104.225104.40
4103514-103514100.849101.01
5105820-105820103.095103.26
6104397-104397101.709101.88
15min1105459-105459102.744101.342.87103.08101.672.87
298516-9851695.97996.30
3106726-106726103.978104.32
4102991-102991100.339100.67
5105887-105887103.161103.50
6104522-104522101.831102.17
20min1105483-105483102.767101.252.74103.28101.762.75
298653-9865396.11396.59
3106584-106584103.840104.36
4103316-103316100.656101.16
5105619-105619102.900103.41
6103906-103906101.231101.74
30min1107701-107701104.928101.763.16105.61102.433.16
298506-9850695.97096.61
3106143-106143103.410104.10
4102916-102916100.266100.94
5105425-105425102.711103.39
6105990-105990103.261103.94
45min1104292-104292101.607100.842.78102.46101.682.78
298450-9845095.91596.71
3106217-106217103.482104.35
4102407-10240799.770100.61
5106026-106026103.296104.15
6103629-103629100.961101.81
极限1104471-104471101.781100.552.69102.81101.562.69
298014-9801495.49096.45
3106026-106026103.296104.33
4102658-102658100.015101.02
5104336-104336101.650102.68
6103717-103717101.046102.06
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2000
标示量(mg)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%
119.562044992033292036702033662042572038240.26
219.492039112042702040900.13
单位质量响应值RSD%判断
10420.4510471.520.35数据可信
供试品溶液-2025042221批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1193170-19317094.46093.863.7694.4693.863.76
2195374-19537495.53895.54
3201758-20175898.66098.66
4190453-19045393.13293.13
5191015-19101593.40793.41
6179825-17982587.93587.93
10min1209464-209464102.428100.381.31102.59100.531.31
2203204-20320499.36799.53
3207066-207066101.256101.42
4204198-20419899.853100.01
5205476-205476100.478100.63
6202204-20220498.87899.02
15min1210828-210828103.095101.021.28103.42101.341.28
2204334-20433499.920100.24
3208468-208468101.941102.27
4204423-20442399.963100.28
5206671-206671101.062101.39
6204814-204814100.154100.47
20min1211170-211170103.262100.811.47103.76101.301.47
2204168-20416899.838100.33
3208249-208249101.834102.34
4204432-20443299.968100.46
5205787-205787100.630101.12
6203147-20314799.33999.82
30min1210248-210248102.812100.641.18103.48101.301.18
2203803-20380399.660100.32
3206335-206335100.898101.57
4204084-20408499.797100.45
5206060-206060100.764101.42
6204306-20430699.906100.55
45min1211070-211070103.214100.591.47104.06101.421.47
2203477-20347799.501100.32
3207110-207110101.277102.12
4203650-20365099.585100.41
5205492-205492100.486101.31
6203434-20343499.480100.29
极限1210666-210666103.016100.381.47104.03101.381.47
2203062-20306299.298100.29
3206703-206703101.078102.09
4203196-20319699.363100.35
5204901-204901100.197101.19
6203115-20311599.324100.30
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2000
标示量(mg)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%
119.562029212037272038792040802036552036520.22
219.492028852035772032310.25
单位质量响应值RSD%判断
10411.6610427.450.11数据可信
供试品溶液-2025042221批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1194002-19400295.10795.434.4695.1195.444.46
2204350-204350100.180100.18
3178927-17892787.71787.72
4195695-19569595.93795.94
5194599-19459995.40095.40
6200428-20042898.25898.26
10min1206527-206527101.248101.211.12101.41101.371.12
2209679-209679102.793102.96
3202895-20289599.46799.61
4205738-205738100.861101.02
5205870-205870100.926101.08
6208014-208014101.977102.14
15min1207224-207224101.589101.281.07101.92101.601.08
2209727-209727102.816103.15
3203189-20318999.61199.92
4205617-205617100.802101.13
5206032-206032101.005101.33
6207752-207752101.848102.18
20min1206810-206810101.386101.060.98101.88101.550.98
2209039-209039102.479102.99
3203385-20338599.707100.19
4204533-204533100.270100.77
5205909-205909100.945101.44
6207140-207140101.548102.05
30min1206186-206186101.081100.820.96101.75101.480.97
2208678-208678102.302102.98
3202831-20283199.436100.08
4204673-204673100.339101.00
5205066-205066100.531101.20
6206477-206477101.223101.90
45min1205732-205732100.858100.621.02101.69101.451.02
2208317-208317102.125102.98
3202441-20244199.245100.05
4204077-204077100.047100.88
5204282-204282100.147100.98
6206600-206600101.283102.12
极限1204904-204904100.452100.150.92101.45101.150.93
2206600-206600101.283102.30
3201679-20167998.87199.85
4202709-20270999.376100.37
5203965-20396599.992100.99
6205879-205879100.930101.94
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