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%
119.642034432033142032572031882032542032910.05
219.702028912028742028820.01
单位质量响应值RSD%判断
10350.8710298.580.36数据可信
供试品溶液-25031101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%
5min1160824-16082479.56781.278.0979.5781.278.09
2150909-15090974.66174.66
3171842-17184285.01885.02
4186620-18662092.32992.33
5152814-15281475.60475.60
6162590-16259080.44180.44
10min1198862-19886298.38697.542.8398.5297.682.83
2203280-203280100.572100.70
3192894-19289495.43395.58
4202461-202461100.167100.32
5188891-18889193.45393.58
6196527-19652797.23197.36
15min1201740-20174099.81099.022.55100.1199.322.55
2206861-206861102.343102.64
3196692-19669297.31297.61
4203520-203520100.691101.01
5192484-19248495.23195.51
6199600-19960098.75199.05
20min1201747-20174799.81399.422.37100.2899.882.37
2207793-207793102.805103.27
3198207-19820798.06298.52
4203305-203305100.584101.07
5193685-19368595.82596.27
6200927-20092799.40899.87
30min1201300-20130099.59299.662.21100.22100.302.21
2208170-208170102.991103.63
3199541-19954198.72299.35
4203336-203336100.599101.26
5194662-19466296.30896.91
6201671-20167199.776100.40
45min1201000-20100099.44499.762.20100.24100.552.20
2208194-208194103.003103.81
3200418-20041899.15699.95
4203040-203040100.453101.28
5194534-19453496.24597.01
6202603-202603100.237101.03
极限1201003-20100399.44599.562.10100.41100.522.10
2207561-207561102.690103.67
3200194-20019499.045100.00
4202048-20204899.962100.95
5194429-19442996.19397.11
6202200-202200100.037101.00
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%
119.642029092030922028822027162029032029000.07
219.702031162029852030500.05
单位质量响应值RSD%判断
10330.9610307.110.17数据可信
供试品溶液-25031101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%
5min1166802-16680282.57074.0510.2982.5774.0610.29
2149529-14952974.01974.02
3131307-13130764.99965.00
4140715-14071569.65669.66
5169197-16919783.75583.76
6140054-14005469.32969.33
10min1196164-19616497.10497.291.5897.2497.411.58
2196056-19605697.05197.17
3191723-19172394.90695.01
4196143-19614397.09497.21
5197907-19790797.96798.11
6201248-20124899.62199.74
15min1197454-19745497.74398.261.0898.0498.551.08
2197070-19707097.55397.84
3196797-19679797.41897.68
4198529-19852998.27598.55
5198547-19854798.28498.59
6202609-202609100.295100.58
20min1197152-19715297.59398.391.1898.0698.841.17
2197199-19719997.61798.06
3197186-19718697.61098.04
4199531-19953198.77199.21
5198420-19842098.22198.69
6203117-203117100.546100.99
30min1197291-19729197.66298.391.0298.2999.001.01
2197032-19703297.53498.14
3198137-19813798.08198.67
4199240-19924098.62799.23
5198346-19834698.18498.81
6202551-202551100.266100.88
45min1197156-19715697.59598.461.1698.3899.241.15
2196988-19698897.51298.29
3198003-19800398.01598.77
4199595-19959598.80399.57
5198472-19847298.24799.04
6203176-203176100.575101.36
极限1196933-19693397.48598.271.1798.4499.211.16
2196549-19654997.29598.23
3197792-19779297.91098.83
4199355-19935598.68499.62
5197631-19763197.83098.79
6202821-202821100.400101.35
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%
119.642026992030222027512029542029612028770.08
219.702019522015572017540.14
单位质量响应值RSD%判断
10329.7910241.320.61数据可信
供试品溶液-25031101批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1164464-16446481.67983.645.5981.6883.645.59
2168823-16882383.84383.84
3151554-15155475.26775.27
4176792-17679287.80187.80
5174460-17446086.64386.64
6174399-17439986.61386.61
10min1194990-19499096.83996.851.7496.9896.991.74
2191817-19181795.26395.40
3193458-19345896.07896.20
4196914-19691497.79497.94
5192150-19215095.42895.57
6200741-20074199.69599.84
15min1196602-19660297.63997.971.3997.9498.271.39
2194523-19452396.60796.91
3196432-19643297.55597.84
4198947-19894798.80499.11
5195184-19518496.93597.24
6201926-201926100.284100.59
20min1196813-19681397.74498.291.3998.2098.751.39
2194085-19408596.38996.85
3197512-19751298.09198.54
4200221-20022199.43799.91
5196956-19695697.81598.28
6201847-201847100.244100.72
30min1197035-19703597.85598.871.4698.4899.491.46
2194820-19482096.75497.37
3199073-19907398.86799.48
4201306-20130699.976100.62
5199321-19932198.99099.62
6202865-202865100.750101.39
45min1196047-19604797.36499.131.7198.1599.921.70
2194900-19490096.79497.58
3200729-20072999.689100.47
4202562-202562100.599101.41
5200197-20019799.425100.22
6203144-203144100.888101.70
极限1195908-19590897.29599.061.7998.24100.021.79
2194144-19414496.41997.36
3200888-20088899.768100.71
4202315-202315100.477101.45
5200778-20077899.713100.67
6202732-202732100.684101.66
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