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%
119.231929691929781933061929171926811929700.12
219.221925231924871925050.02
单位质量响应值RSD%判断
10034.8410015.870.14数据可信
供试品溶液-2025042021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%
5min1141620-14162072.15882.5722.0472.1682.5722.04
2187439-18743995.50395.50
3199439-199439101.617101.62
4117551-11755159.89459.89
5132060-13206067.28767.29
6194204-19420498.95098.95
10min1195305-19530599.511100.611.5399.63100.751.55
2198654-198654101.217101.38
3203008-203008103.436103.61
4196923-196923100.335100.44
5195308-19530899.51399.62
6195543-19554399.63299.80
15min1195187-19518799.451100.761.4299.74101.061.42
2198429-198429101.103101.43
3202721-202721103.290103.63
4198025-198025100.897101.16
5196936-196936100.342100.62
6195221-19522199.46899.80
20min1194516-19451699.109100.461.5199.56100.931.52
2198032-198032100.900101.40
3202318-202318103.084103.60
4197734-197734100.749101.18
5196166-19616699.950100.39
6194252-19425298.97499.47
30min1193825-19382598.757100.191.5499.37100.831.55
2197398-197398100.577101.24
3201911-201911102.877103.56
4196955-196955100.352100.95
5196128-19612899.930100.54
6193650-19365098.66899.33
45min1193623-19362398.654100.081.5399.44100.891.53
2197210-197210100.482101.31
3201728-201728102.784103.64
4196650-196650100.196100.97
5195619-19561999.671100.45
6193717-19371798.70299.53
极限1192743-19274398.20699.791.5399.15100.761.54
2197243-197243100.498101.50
3200979-200979102.402103.43
4195859-19585999.793100.73
5194813-19481399.260100.20
6193459-19345998.57099.56
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%
119.231927801931121926961921431925221926510.19
219.221917201919301918250.08
单位质量响应值RSD%判断
10018.259980.490.27数据可信
供试品溶液-2025042021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%
5min1191165-19116597.65581.9417.4097.6581.9417.40
2111322-11132256.86856.87
3169127-16912786.39786.40
4161377-16137782.43882.44
5150154-15015476.70576.70
6179225-17922591.55691.56
10min1196506-196506100.38399.570.76100.5599.710.77
2195634-19563499.938100.03
3193821-19382199.01299.16
4192633-19263398.40598.54
5194797-19479799.51099.64
6196131-196131100.192100.34
15min1196223-196223100.23999.720.71100.57100.030.70
2196559-196559100.410100.67
3193376-19337698.78499.09
4193740-19374098.97099.27
5195206-19520699.719100.01
6196198-196198100.226100.55
20min1196349-196349100.30399.580.90100.80100.050.89
2196194-196194100.224100.65
3192956-19295698.57099.04
4192608-19260898.39298.86
5195137-19513799.684100.14
6196404-196404100.331100.82
30min1195833-195833100.04099.330.80100.7099.970.79
2195456-19545699.847100.44
3192509-19250998.34298.98
4192613-19261398.39599.03
5194519-19451999.36899.99
6195779-195779100.012100.67
45min1195302-19530299.76899.150.89100.6099.950.88
2195683-19568399.963100.73
3191895-19189598.02898.83
4191967-19196798.06598.86
5194447-19444799.332100.12
6195205-19520599.719100.54
极限1194743-19474399.48398.830.88100.4899.800.87
2195105-19510599.668100.60
3191682-19168297.91998.88
4191130-19113097.63798.59
5193592-19359298.89599.85
6194585-19458599.402100.39
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