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%
118.932012772018102018182018632015532016640.13
2 19.022004322004632004480.02
单位质量响应值RSD%判断
10653.1410538.800.77数据可信
供试品溶液-2025032621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%
5min1203300-20330098.00999.981.2198.0199.981.21
2208005-208005100.277100.28
3208169-208169100.356100.36
4209758-209758101.122101.12
5209590-209590101.041101.04
6205567-20556799.10299.10
10min1204879-20487998.770100.861.1898.93101.031.18
2209025-209025100.769100.94
3209697-209697101.093101.26
4211685-211685102.051102.22
5211413-211413101.920102.09
6208631-208631100.579100.74
15min1203555-20355598.132100.721.4998.46101.051.48
2208339-208339100.438100.77
3209612-209612101.052101.39
4212411-212411102.401102.74
5211287-211287101.860102.20
6208277-208277100.408100.74
20min1203311-20331198.014100.531.4098.51101.041.40
2208202-208202100.372100.87
3208773-208773100.648101.15
4212135-212135102.268102.78
5209893-209893101.188101.70
6208892-208892100.705101.21
30min1203037-20303797.882100.181.3998.54100.851.38
2207957-207957100.254100.92
3208186-208186100.365101.04
4211542-211542101.982102.66
5209508-209508101.002101.68
6206606-20660699.603100.27
45min1202064-20206497.41399.911.4998.23100.751.49
2207238-20723899.908100.74
3208016-208016100.283101.12
4211124-211124101.781102.63
5209033-209033100.773101.62
6206002-20600299.312100.15
极限1202003-20200397.38499.631.4998.36100.631.49
2206234-20623499.424100.43
3206446-20644699.526100.53
4211206-211206101.820102.84
5208514-208514100.523101.54
6205565-20556599.101100.10
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%
118.932006572005232010632009462010882008550.13
2 19.022009492012522011000.11
单位质量响应值RSD%判断
10610.4110573.080.25数据可信
供试品溶液-2025032621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%
5min1208148-208148100.38498.614.23100.3898.614.23
2209499-209499101.035101.04
3207867-207867100.248100.25
4204358-20435898.55698.56
5187278-18727890.31990.32
6209688-209688101.126101.13
10min1210204-210204101.375101.591.01101.54101.761.01
2214727-214727103.557103.72
3209605-209605101.086101.25
4208519-208519100.563100.73
5210499-210499101.518101.67
6210356-210356101.449101.62
15min1209908-209908101.233101.340.96101.57101.680.97
2214167-214167103.286103.63
3209088-209088100.837101.17
4208720-208720100.660100.99
5209588-209588101.078101.40
6209360-209360100.968101.31
20min1209189-209189100.886101.101.07101.39101.601.07
2214130-214130103.269103.78
3208667-208667100.634101.14
4208207-208207100.412100.91
5209134-209134100.859101.35
6208510-208510100.558101.06
30min1208633-208633100.618100.741.02101.29101.411.02
2213044-213044102.745103.43
3207241-20724199.946100.62
4207496-207496100.069100.74
5208342-208342100.477101.13
6208537-208537100.571101.24
45min1208117-208117100.369100.650.96101.21101.490.97
2212558-212558102.511103.37
3207404-207404100.025100.86
4206979-20697999.820100.65
5208807-208807100.702101.53
6208331-208331100.472101.31
极限1207913-207913100.270100.200.89101.28101.210.89
2211330-211330101.918102.95
3206277-20627799.481100.49
4206663-20666399.668100.67
5207132-20713299.894100.89
6207326-20732699.987101.00
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%
118.932016602018052011412011762013112014190.15
2 19.022011522011222011370.02
单位质量响应值RSD%判断
10640.2010575.030.44数据可信
供试品溶液-2025032621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%
5min1204937-20493798.68898.471.3298.6998.471.32
2207359-20735999.85499.85
3205954-20595499.17899.18
4204185-20418598.32698.33
5204938-20493898.68898.69
6199488-19948896.06496.06
10min1206137-20613799.26699.141.1899.4399.301.18
2208579-208579100.442100.61
3206802-20680299.58699.75
4205541-20554198.97999.14
5206767-20676799.56999.73
6201396-20139696.98397.14
15min1205456-20545698.93898.921.3899.2799.241.37
2208073-208073100.198100.53
3207232-20723299.793100.12
4205497-20549798.95899.29
5206145-20614599.27099.60
6200053-20005396.33696.66
20min1205401-20540198.91198.821.2899.4199.321.28
2207906-207906100.118100.62
3206612-20661299.49499.99
4205167-20516798.79999.29
5205954-20595499.17899.67
6200289-20028996.45096.93
30min1204592-20459298.52298.601.2799.1899.261.27
2207615-20761599.977100.65
3206365-20636599.376100.04
4204825-20482598.63499.29
5205130-20513098.78199.44
6200000-20000096.31096.95
45min1204538-20453898.49698.361.2799.3299.181.27
2207337-20733799.844100.68
3205236-20523698.83299.66
4204120-20412098.29499.12
5204767-20476798.60699.43
6199529-19952996.08496.89
极限1203704-20370498.09498.061.4199.0899.051.41
2206540-20654099.460100.46
3205474-20547498.94699.94
4203728-20372898.10699.09
5204088-20408898.27999.27
6198271-19827195.47896.44
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