氢溴酸伏硫西汀片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号D382/2305001对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.83对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数0.7867
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.321799171798301797901795981797391797750.07
214.401801691801211801450.02
单位质量响应值RSD%判断
12554.1212510.070.25数据可信
供试品溶液-2024051221批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
2min1111903-11190363.11563.057.7963.1163.057.79
299606-9960656.17956.18
3112019-11201963.18063.18
4112040-11204063.19263.19
5126616-12661671.41371.41
6108517-10851761.20561.21
5min1167004-16700494.19394.631.3294.1994.631.32
2164287-16428792.66092.66
3170821-17082196.34696.35
4167368-16736894.39894.40
5169219-16921995.44295.44
6167959-16795994.73194.73
10min1173707-17370797.97399.671.3697.9799.671.36
2176512-17651299.55599.56
3178635-178635100.753100.75
4174169-17416998.23498.23
5177660-177660100.203100.20
6179607-179607101.301101.30
15min1174289-17428998.302100.271.5698.30100.261.56
2178380-178380100.609100.61
3180764-180764101.954101.95
4174577-17457798.46498.46
5178327-178327100.579100.58
6180303-180303101.694101.69
20min1173911-17391198.088100.041.5398.09100.041.53
2177770-177770100.265100.26
3180546-180546101.831101.83
4174359-17435998.34198.34
5178054-178054100.425100.43
6179564-179564101.277101.28
30min1173835-17383598.045100.001.4498.05100.001.44
2177835-177835100.302100.30
3180360-180360101.726101.73
4174594-17459498.47498.47
5178211-178211100.514100.51
6178926-178926100.917100.92
45min1173606-17360697.91699.961.4797.9299.961.47
2178489-178489100.670100.67
3180546-180546101.831101.83
4174650-17465098.50598.51
5178125-178125100.465100.47
6177917-177917100.348100.35
60min1173442-17344297.82499.811.5897.8299.811.58
2177468-177468100.095100.09
3180263-180263101.671101.67
4173705-17370597.97297.97
5178258-178258100.540100.54
6178684-178684100.780100.78
极限1173952-17395298.111100.061.4398.11100.061.43
2178446-178446100.646100.65
3180302-180302101.693101.69
4174708-17470898.53898.54
5177890-177890100.333100.33
6179167-179167101.053101.05
氢溴酸伏硫西汀片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号D382/2305001对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.83对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数0.7867
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.321822891804041808881810261809661811150.39
214.401806541803191804860.14
单位质量响应值RSD%判断
12647.7012533.750.64数据可信
供试品溶液-2024051221批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
2min1171504-17150496.28291.045.8696.2891.045.86
2170268-17026895.58895.59
3161657-16165790.75490.75
4168076-16807694.35894.36
5151969-15196985.31585.32
6149568-14956883.96783.97
5min1171784-17178496.43998.071.6196.4498.071.61
2171456-17145696.25596.26
3178964-178964100.470100.47
4175968-17596898.78898.79
5175493-17549398.52198.52
6174456-17445697.93997.94
10min1175649-17564998.60998.031.1898.6198.031.18
2171785-17178596.44096.44
3177418-17741899.60299.60
4175859-17585998.72798.73
5173371-17337197.33097.33
6173629-17362997.47597.47
15min1173637-17363797.47997.330.8797.4897.330.87
2173427-17342797.36297.36
3175605-17560598.58498.58
4173997-17399797.68297.68
5172331-17233196.74696.75
6171189-17118996.10596.11
20min1173506-17350697.40696.520.9397.4196.520.93
2169391-16939195.09695.10
3173754-17375497.54597.55
4171505-17150596.28396.28
5171968-17196896.54396.54
6171433-17143396.24296.24
30min1171824-17182496.46296.422.5496.4696.422.54
2168761-16876194.74294.74
3177118-17711899.43499.43
4174182-17418297.78597.79
5173722-17372297.52797.53
6164894-16489492.57192.57
45min1168845-16884594.78995.721.4894.7995.721.48
2167354-16735493.95293.95
3173947-17394797.65497.65
4171611-17161196.34296.34
5172366-17236696.76696.77
6168898-16889894.81994.82
60min1164526-16452692.36594.281.4492.3694.281.45
2166396-16639693.41493.41
3171460-17146096.25796.26
4168813-16881394.77194.77
5167248-16724893.89393.89
6169176-16917694.97594.98
极限1166074-16607493.23494.771.2693.2394.771.26
2168527-16852794.61194.61
3171839-17183996.47096.47
4170708-17070895.83595.84
5167501-16750194.03594.03
6168192-16819294.42394.42
氢溴酸伏硫西汀片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号D382/2305001对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.83对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数0.7867
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.321797011797781796131794051793891795770.10
214.401792721792421792570.02
单位质量响应值RSD%判断
12540.2912448.400.53数据可信
供试品溶液-2024051221批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
2min1167845-16784594.95475.5723.0194.9575.5723.00
2104564-10456459.15459.15
3163633-16363392.57192.57
4103073-10307358.31158.31
5110470-11047062.49662.50
6151907-15190785.93885.94
5min1173385-17338598.08897.780.5398.0997.780.52
2171934-17193497.26797.27
3171649-17164997.10697.11
4172750-17275097.72997.73
5173997-17399798.43498.43
6173284-17328498.03198.03
10min1178438-178438100.947100.980.55100.95100.980.55
2177231-177231100.264100.26
3178408-178408100.930100.93
4177728-177728100.545100.55
5179752-179752101.690101.69
6179437-179437101.512101.51
15min1176888-176888100.070100.650.65100.07100.660.65
2176473-17647399.83599.84
3178041-178041100.722100.72
4177717-177717100.539100.54
5179327-179327101.450101.45
6179085-179085101.313101.31
20min1177147-177147100.216100.740.67100.22100.740.67
2176933-176933100.095100.10
3178067-178067100.737100.74
4177293-177293100.299100.30
5179369-179369101.473101.47
6179661-179661101.639101.64
30min1177521-177521100.428100.390.94100.43100.390.94
2176388-17638899.78799.79
3177912-177912100.649100.65
4174782-17478298.87898.88
5179361-179361101.469101.47
6178736-178736101.115101.12
45min1177817-177817100.595100.560.73100.60100.560.73
2176230-17623099.69899.70
3178113-178113100.763100.76
4176228-17622899.69799.70
5179220-179220101.389101.39
6178964-178964101.244101.24
60min1177002-177002100.134100.300.71100.13100.300.71
2175705-17570599.40199.40
3177497-177497100.414100.41
4176175-17617599.66799.67
5178422-178422100.938100.94
6178943-178943101.232101.23
极限1177412-177412100.366100.440.59100.37100.440.59
2176375-17637599.78099.78
3177503-177503100.418100.42
4176481-17648199.84099.84
5178478-178478100.969100.97
6178990-178990101.259101.26
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