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%
119.261013581009911012601012161013181012290.15
219.171011911010971011440.07
单位质量响应值RSD%判断
5255.925276.160.28数据可信
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%
5min1101340-10134098.30098.931.1798.3098.931.17
2103112-103112100.019100.02
3100329-10032997.32097.32
4102615-10261599.53799.54
5103278-103278100.180100.18
6101269-10126998.23298.23
10min1102649-10264999.570100.671.2199.73100.841.21
2104884-104884101.738101.90
3102559-10255999.48399.65
4104309-104309101.180101.35
5105439-105439102.277102.44
6102880-10288099.79499.96
15min1102911-10291199.824100.791.07100.15101.121.07
2104824-104824101.680102.02
3103266-103266100.169100.50
4104327-104327101.198101.53
5105417-105417102.255102.59
6102710-10271099.62999.96
20min1102862-10286299.777100.861.50100.27101.361.50
2104877-104877101.731102.24
3103062-10306299.971100.47
4104002-104002100.883101.39
5106595-106595103.398103.91
6102456-10245699.38399.88
30min1101993-10199398.934100.471.3399.60101.141.33
2104463-104463101.330102.01
3102842-10284299.757100.42
4104040-104040100.919101.59
5105626-105626102.458103.14
6102474-10247499.400100.06
45min1102094-10209499.032100.111.0499.86100.951.04
2104224-104224101.098101.94
3102552-10255299.476100.30
4103470-103470100.367101.21
5104639-104639101.500102.35
6102264-10226499.197100.02
极限1101853-10185398.79899.981.0799.79100.981.06
2104012-104012100.892101.90
3102672-10267299.592100.59
4103776-103776100.663101.67
5104265-104265101.138102.16
6101837-10183798.78399.78
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%
119.261008351011261009531011141009301009920.13
219.171010181010541010360.03
单位质量响应值RSD%判断
5243.615270.530.37数据可信
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%
5min1104186-104186101.234100.860.90101.23100.860.90
2105454-105454102.466102.47
3103446-103446100.515100.51
4103656-103656100.719100.72
5103276-103276100.350100.35
6102801-10280199.88899.89
10min1105276-105276102.293102.061.02102.46102.221.02
2106648-106648103.626103.80
3105611-105611102.618102.79
4104103-104103101.153101.32
5104853-104853101.882102.05
6103706-103706100.767100.93
15min1105144-105144102.165101.980.87102.50102.310.87
2106337-106337103.324103.67
3105529-105529102.539102.88
4103858-103858100.915101.25
5104576-104576101.613101.95
6104254-104254101.300101.63
20min1104926-104926101.953101.670.85102.46102.180.85
2105871-105871102.871103.39
3105348-105348102.363102.87
4103886-103886100.942101.45
5104107-104107101.157101.66
6103664-103664100.727101.23
30min1104637-104637101.672101.560.90102.35102.230.90
2105946-105946102.944103.63
3105122-105122102.143102.82
4103504-103504100.571101.24
5104290-104290101.335102.01
6103602-103602100.666101.34
45min1106296-106296103.284101.471.19104.13102.321.18
2105670-105670102.676103.53
3103726-103726100.787101.64
4103528-103528100.594101.43
5104004-104004101.057101.90
6103367-103367100.438101.28
极限1103982-103982101.036101.170.85102.06102.190.85
2105476-105476102.487103.52
3104845-104845101.874102.89
4103264-103264100.338101.35
5103841-103841100.899101.91
6103312-103312100.385101.39
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%
119.262018842019932020132018122020932019590.06
219.172012242013692012960.06
单位质量响应值RSD%判断
10485.9310500.570.10数据可信
供试品溶液-2025042221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%
5min1176711-17671186.02293.594.9986.0293.584.99
2201400-20140098.04198.04
3201017-20101797.85497.85
4185823-18582390.45890.46
5192379-19237993.64993.65
6196157-19615795.48895.49
10min1187604-18760491.32597.833.8191.4797.993.81
2205752-205752100.159100.32
3205582-205582100.077100.24
4195771-19577195.30195.45
5205920-205920100.241100.40
6205216-20521699.898100.06
15min1190301-19030192.63898.303.3792.9398.623.38
2206473-206473100.510100.84
3205736-205736100.152100.48
4196933-19693395.86696.18
5206979-206979100.757101.08
6205153-20515399.868100.19
20min1191380-19138093.16398.603.1693.6199.083.17
2206215-206215100.385100.88
3207056-207056100.794101.29
4198326-19832696.54497.01
5207299-207299100.912101.40
6204969-20496999.778100.27
30min1192566-19256693.74098.552.8594.3599.192.85
2206530-206530100.538101.20
3206044-206044100.301100.97
4198281-19828196.52297.15
5206432-206432100.490101.15
6204771-20477199.682100.34
45min1194495-19449594.67998.732.5395.4499.542.54
2206490-206490100.519101.35
3205209-20520999.895100.73
4198641-19864196.69897.49
5207517-207517101.019101.85
6204490-20449099.545100.37
极限1192317-19231793.61998.302.6894.5499.282.69
2205914-205914100.238101.24
3204794-20479499.693100.69
4198754-19875496.75397.71
5205802-205802100.184101.18
6204004-20400499.308100.30
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%
119.262015352017612014802017712017282016550.07
219.172014632015392015010.03
单位质量响应值RSD%判断
10470.1510511.270.28数据可信
供试品溶液-2025042221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%
5min1192639-19263993.79991.436.6993.8091.436.69
2191522-19152293.25593.26
3201376-20137698.05398.05
4196561-19656195.70995.71
5174034-17403484.74084.74
6170487-17048783.01383.01
10min1203723-20372399.19698.221.8099.3598.371.81
2202305-20230598.50698.66
3206516-206516100.556100.72
4202723-20272398.70998.87
5198520-19852096.66396.80
6196537-19653795.69795.84
15min1205505-205505100.06499.101.12100.3999.421.13
2203077-20307798.88199.20
3206428-206428100.513100.84
4203643-20364399.15799.48
5202501-20250198.60198.90
6200056-20005697.41097.71
20min1205004-20500499.82099.531.11100.31100.011.11
2202873-20287398.78299.27
3206242-206242100.423100.92
4204629-20462999.637100.13
5206869-206869100.728101.19
6200779-20077997.76398.22
30min1205524-205524100.07399.700.79100.73100.350.79
2203651-20365199.16199.81
3206544-206544100.570101.24
4203907-20390799.28699.94
5206305-206305100.453101.09
6202585-20258598.64299.27
45min1205965-205965100.28899.720.88101.11100.530.87
2202609-20260998.65499.47
3205683-205683100.150100.98
4204185-20418599.421100.24
5207227-207227100.902101.70
6203121-20312198.90399.69
极限1205956-205956100.28399.590.96101.27100.570.95
2202964-20296498.82699.81
3205420-205420100.022101.02
4202755-20275598.72599.71
5207264-207264100.920101.89
6202796-20279698.74599.70
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