氢溴酸氟硫西汀口崩片项目信息
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%
114.531846481846001846591845631843991845740.06
214.561849191849901849540.03
单位质量响应值RSD%判断
12702.9612702.880.01数据可信
供试品溶液-24050601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%
2min1133588-13358874.33272.492.8074.3372.492.79
2126742-12674270.52370.52
3135199-13519975.22975.23
4130256-13025672.47872.48
5129842-12984272.24872.25
6126013-12601370.11770.12
5min1165121-16512191.87892.830.6891.8892.820.68
2165792-16579292.25192.25
3167930-16793093.44193.44
4167774-16777493.35493.35
5167240-16724093.05793.06
6167092-16709292.97592.97
10min1167668-16766893.29594.310.7293.3094.310.71
2168353-16835393.67693.68
3170083-17008394.63994.64
4170106-17010694.65294.65
5169958-16995894.56994.57
6170802-17080295.03995.04
15min1168705-16870593.87295.070.9393.8795.070.93
2169401-16940194.25994.26
3172458-17245895.96095.96
4172516-17251695.99395.99
5170647-17064794.95394.95
6171451-17145195.40095.40
20min1167705-16770593.31695.040.9793.3295.040.96
2170544-17054494.89594.90
3172318-17231895.88395.88
4171461-17146195.40695.41
5170967-17096795.13195.13
6171827-17182795.60995.61
30min1168844-16884493.95095.430.8093.9595.420.80
2171741-17174195.56295.56
3171427-17142795.38795.39
4172268-17226895.85595.85
5172104-17210495.76495.76
6172600-17260096.04096.04
45min1169960-16996094.57196.181.0294.5796.181.02
2172026-17202695.72095.72
3174315-17431596.99496.99
4174897-17489797.31897.32
5172755-17275596.12696.13
6173211-17321196.37996.38
60min1169508-16950894.31996.031.0794.3296.031.07
2172300-17230095.87395.87
3174162-17416296.90996.91
4174575-17457597.13897.14
5171837-17183795.61595.61
6173098-17309896.31796.32
极限1169087-16908794.08595.991.1194.0895.981.12
2172052-17205295.73595.73
3173393-17339396.48196.48
4174757-17475797.24097.24
5172496-17249695.98295.98
6173230-17323096.39096.39
氢溴酸氟硫西汀口崩片项目信息
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%
114.531849991850611848991850091849631849860.04
214.561851281851501851390.01
单位质量响应值RSD%判断
12731.3112715.590.09数据可信
供试品溶液-24050602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%
2min1129095-12909571.71672.554.4271.7272.554.42
2121545-12154567.52267.52
3134480-13448074.70874.71
4131248-13124872.91272.91
5138508-13850876.94576.95
6128698-12869871.49671.50
5min1166855-16685592.69392.621.4692.6992.621.46
2166246-16624692.35592.35
3169791-16979194.32494.32
4169204-16920493.99894.00
5163814-16381491.00491.00
6164435-16443591.34991.35
10min1169399-16939994.10694.821.6894.1194.821.68
2170496-17049694.71694.72
3175557-17555797.52797.53
4172334-17233495.73795.74
5168520-16852093.61893.62
6167827-16782793.23393.23
15min1168586-16858693.65595.271.7593.6595.271.75
2171073-17107395.03695.04
3176816-17681698.22798.23
4172890-17289096.04696.05
5169898-16989894.38494.38
6169737-16973794.29494.29
20min1171180-17118095.09695.551.7895.1095.551.78
2171294-17129495.15995.16
3177531-17753198.62498.62
4173186-17318696.21096.21
5169688-16968894.26794.27
6169135-16913593.96093.96
30min1171114-17111495.05995.961.9295.0695.961.91
2171611-17161195.33595.34
3178712-17871299.28099.28
4174357-17435796.86196.86
5170689-17068994.82394.82
6169906-16990694.38894.39
45min1171920-17192095.50796.191.7695.5196.191.76
2171988-17198895.54595.54
3178690-17869099.26899.27
4174588-17458896.98996.99
5170531-17053194.73594.74
6171184-17118495.09895.10
60min1172542-17254295.85295.941.2095.8595.941.20
2172259-17225995.69595.70
3176078-17607897.81797.82
4173845-17384596.57696.58
5170164-17016494.53194.53
6171320-17132095.17395.17
极限1170767-17076794.86695.901.7894.8795.901.78
2172791-17279195.99195.99
3178027-17802798.89998.90
4173868-17386896.58996.59
5169629-16962994.23494.23
6170632-17063294.79194.79
氢溴酸氟硫西汀口崩片项目信息
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%
114.531852641851281850571849071850431850800.08
214.561835191837191836190.08
单位质量响应值RSD%判断
12737.7812611.200.71数据可信
供试品溶液-24050603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%
2min1125847-12584770.18471.564.4470.1871.564.44
2122945-12294568.56568.57
3129124-12912472.01172.01
4123111-12311168.65868.66
5137927-13792776.92176.92
6130920-13092073.01373.01
5min1169139-16913994.32794.921.9494.3394.921.93
2169316-16931694.42694.43
3173662-17366296.85096.85
4168391-16839193.91093.91
5166040-16604092.59992.60
6174621-17462197.38497.38
10min1172626-17262696.27296.761.5996.2796.761.59
2173932-17393297.00097.00
3176062-17606298.18898.19
4171622-17162295.71295.71
5169732-16973294.65894.66
6177078-17707898.75598.75
15min1172221-17222196.04696.931.5496.0596.931.54
2173697-17369796.86996.87
3176647-17664798.51498.51
4171368-17136895.57095.57
5171429-17142995.60495.60
6177477-17747798.97798.98
20min1172784-17278496.36097.151.5796.3697.151.58
2174674-17467497.41497.41
3176613-17661398.49598.50
4170099-17009994.86394.86
5173413-17341396.71196.71
6177646-17764699.07199.07
30min1172481-17248196.19197.591.1396.1997.591.14
2175652-17565297.95997.96
3177300-17730098.87898.88
4173756-17375696.90296.90
5173671-17367196.85596.85
6177045-17704598.73698.74
45min1174194-17419497.14698.211.1697.1598.211.16
2176353-17635398.35098.35
3178247-17824799.40799.41
4174467-17446797.29997.30
5174546-17454697.34397.34
6178814-17881499.72399.72
60min1174720-17472097.44098.371.4697.4498.371.46
2176738-17673898.56598.57
3178931-17893199.78899.79
4173931-17393197.00097.00
5174127-17412797.10997.11
6179904-179904100.331100.33
极限1174745-17474597.45498.001.1297.4598.001.12
2176879-17687998.64498.64
3177779-17777999.14699.15
4173422-17342296.71696.72
5173813-17381396.93496.93
6177661-17766199.08099.08
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