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%
114.161812261812671811551811061809301811370.08
214.071821441821521821480.01
单位质量响应值RSD%判断
12792.1612945.840.85数据可信
供试品溶液-24050601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%
2min1118011-11801164.82072.675.4264.8272.675.42
2133778-13377873.48073.48
3134437-13443773.84273.84
4134038-13403873.62373.62
5137856-13785675.72075.72
6135750-13575074.56374.56
5min1163288-16328889.68990.901.4389.6990.901.43
2163217-16321789.65089.65
3164841-16484190.54290.54
4165060-16506090.66290.66
5167305-16730591.89591.90
6169221-16922192.94792.95
10min1174730-17473095.97397.180.9995.9797.180.99
2177840-17784097.68297.68
3175349-17534996.31396.31
4178650-17865098.12798.13
5178788-17878898.20298.20
6176220-17622096.79296.79
15min1175447-17544796.36797.540.8796.3797.540.87
2178438-17843898.01098.01
3176420-17642096.90296.90
4178627-17862798.11498.11
5179540-17954098.61598.62
6177014-17701497.22897.23
20min1175442-17544296.36497.350.8396.3697.350.83
2177874-17787497.70097.70
3176327-17632796.85196.85
4178067-17806797.80697.81
5179393-17939398.53598.53
6176292-17629296.83196.83
30min1174901-17490196.06797.421.0296.0797.421.02
2177986-17798697.76297.76
3176650-17665097.02897.03
4178292-17829297.93097.93
5180026-18002698.88298.88
6176279-17627996.82496.82
45min1174732-17473295.97497.461.0995.9797.461.09
2178004-17800497.77297.77
3177253-17725397.35997.36
4178180-17818097.86897.87
5180365-18036599.06999.07
6176110-17611096.73196.73
60min1175253-17525396.26197.731.2196.2697.731.21
2178153-17815397.85497.85
3177623-17762397.56297.56
4178992-17899298.31498.31
5181331-18133199.59999.60
6176248-17624896.80796.81
极限1175415-17541596.35098.151.4196.3598.151.41
2177626-17762697.56497.56
3178182-17818297.86997.87
4180472-18047299.12799.13
5182614-182614100.304100.30
6177853-17785397.68997.69
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%
114.161817551817381817511816901817471817360.02
214.071817841818921818380.05
单位质量响应值RSD%判断
12834.4612923.810.50数据可信
供试品溶液-24050601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%
2min1127196-12719669.80870.183.9569.8170.183.95
2124336-12433668.23868.24
3126986-12698669.69369.69
4137712-13771275.57975.58
5127182-12718269.80069.80
6123844-12384467.96867.97
5min1167607-16760791.98692.871.2491.9992.871.24
2169213-16921392.86892.87
3168494-16849492.47392.47
4166953-16695391.62791.63
5172734-17273494.80094.80
6170309-17030993.46993.47
10min1174051-17405195.52396.131.0695.5296.131.06
2173603-17360395.27795.28
3174495-17449595.76795.77
4173878-17387895.42895.43
5178034-17803497.70997.71
6176888-17688897.08097.08
15min1175831-17583196.50096.841.1296.5096.841.12
2174823-17482395.94795.95
3175342-17534296.23196.23
4174891-17489195.98495.98
5179476-17947698.50098.50
6178316-17831697.86497.86
20min1176240-17624096.72497.141.1796.7297.131.17
2175201-17520196.15496.15
3175345-17534596.23396.23
4175946-17594696.56396.56
5179630-17963098.58598.58
6179574-17957498.55498.55
30min1176812-17681297.03897.281.2997.0497.281.29
2174837-17483795.95495.95
3175552-17555296.34796.35
4176169-17616996.68596.69
5179965-17996598.76998.77
6180193-18019398.89498.89
45min1178461-17846197.94397.571.5997.9497.571.58
2175610-17561096.37996.38
3175478-17547896.30696.31
4175038-17503896.06596.06
5181175-18117599.43399.43
6180940-18094099.30499.30
60min1178792-17879298.12597.941.4898.1297.941.49
2176220-17622096.71396.71
3176039-17603996.61496.61
4176489-17648996.86196.86
5181772-18177299.76099.76
6181464-18146499.59199.59
极限1179555-17955598.54498.091.7398.5498.091.73
2175649-17564996.40096.40
3176193-17619396.69996.70
4176360-17636096.79096.79
5182172-18217299.98099.98
6182422-182422100.117100.12
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%
114.161815251814951814941814741813161814610.05
214.071820221817581818900.11
单位质量响应值RSD%判断
12815.0412927.510.62数据可信
供试品溶液-24050602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%
2min1130171-13017171.48571.343.6171.4871.343.61
2129941-12994171.35871.36
3128757-12875770.70870.71
4138614-13861476.12176.12
5126876-12687669.67569.68
6125094-12509468.69768.70
5min1169357-16935793.00494.061.0793.0094.061.07
2173173-17317395.10095.10
3171418-17141894.13694.14
4168983-16898392.79992.80
5173320-17332095.18195.18
6171456-17145694.15794.16
10min1172731-17273194.85796.060.8894.8696.060.88
2176120-17612096.71896.72
3174904-17490496.05096.05
4173680-17368095.37895.38
5176860-17686097.12597.12
6175290-17529096.26296.26
15min1173009-17300995.01096.210.8395.0196.200.83
2176136-17613696.72796.73
3175349-17534996.29596.29
4174082-17408295.59995.60
5177017-17701797.21197.21
6175520-17552096.38996.39
20min1173796-17379695.44296.660.9095.4496.660.90
2177529-17752997.49297.49
3175676-17567696.47496.47
4174757-17475795.97095.97
5177830-17783097.65797.66
6176502-17650296.92896.93
30min1175262-17526296.24797.040.7996.2597.040.79
2178215-17821597.86997.87
3176627-17662796.99797.00
4174972-17497296.08896.09
5178148-17814897.83297.83
6177015-17701597.21097.21
45min1175220-17522096.22497.170.8896.2297.180.89
2179012-17901298.30698.31
3176918-17691897.15697.16
4175110-17511096.16496.16
5178049-17804997.77897.78
6177396-17739697.41997.42
60min1176405-17640596.87597.440.7696.8797.440.76
2179214-17921498.41798.42
3177394-17739497.41897.42
4175452-17545296.35196.35
5178179-17817997.84997.85
6177987-17798797.74397.74
极限1178417-17841797.98098.100.8797.9898.100.87
2180168-18016898.94198.94
3178927-17892798.26098.26
4175736-17573696.50796.51
5178934-17893498.26498.26
6179610-17961098.63598.63
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