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%
114.151825051827241828411826501820161825470.18
214.161830791832731831760.08
单位质量响应值RSD%判断
12900.8512936.160.20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%
2min1105750-10575057.86059.559.4257.8659.569.42
2118613-11861364.89864.90
3110375-11037560.39160.39
4111844-11184461.19561.19
5116397-11639763.68663.69
690100-9010049.29849.30
5min1165604-16560490.60991.322.4090.6191.322.40
2166305-16630590.99390.99
3174835-17483595.66095.66
4165426-16542690.51290.51
5165716-16571690.67090.67
6163556-16355689.48989.49
10min1170957-17095793.53894.951.7493.5494.961.75
2173256-17325694.79694.80
3179487-17948798.20598.21
4172272-17227294.25894.26
5172292-17229294.26894.27
6173003-17300394.65794.66
15min1172569-17256994.42095.681.7494.4295.681.74
2174635-17463595.55095.55
3180685-18068598.86198.86
4172713-17271394.49994.50
5173486-17348694.92294.92
6175145-17514595.82995.83
20min1172178-17217894.20695.731.6794.2195.741.67
2176313-17631396.46996.47
3180022-18002298.49898.50
4172763-17276394.52694.53
5173423-17342394.88794.89
6175104-17510495.80795.81
30min1173104-17310494.71396.102.3394.7196.102.33
2174659-17465995.56495.56
3183690-183690100.505100.50
4172751-17275194.52094.52
5173932-17393295.16695.17
6175752-17575296.16296.16
45min1173609-17360994.98996.141.6894.9996.141.68
2175548-17554896.05096.05
3181388-18138899.24599.25
4173226-17322694.78094.78
5174991-17499195.74595.75
6175510-17551096.02996.03
60min1173642-17364295.00796.031.7795.0196.031.77
2175889-17588996.23796.24
3181378-18137899.24099.24
4172645-17264594.46294.46
5174321-17432195.37995.38
6175218-17521895.86995.87
极限1173382-17338294.86595.661.8794.8695.661.88
2174556-17455695.50795.51
3181045-18104599.05899.06
4171360-17136093.75993.76
5174161-17416195.29195.29
6174503-17450395.47895.48
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%
114.151848431848981845251851701841221847120.22
214.161841511842801842160.05
单位质量响应值RSD%判断
13053.8513009.600.25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%
2min1127292-12729269.04269.935.7869.0469.935.78
2127673-12767369.24969.25
3124245-12424567.38967.39
4137483-13748374.56974.57
5119029-11902964.56064.56
6137872-13787274.78074.78
5min1167345-16734590.76691.171.5390.7791.171.53
2170154-17015492.29092.29
3164536-16453689.24389.24
4167558-16755890.88290.88
5167129-16712990.64990.65
6171852-17185293.21193.21
10min1168289-16828991.27892.691.2391.2892.691.23
2172349-17234993.48093.48
3168392-16839291.33491.33
4171371-17137192.95092.95
5171672-17167293.11393.11
6173303-17330393.99894.00
15min1171171-17117192.84293.361.5392.8493.361.53
2172745-17274593.69593.70
3167440-16744090.81890.82
4173023-17302393.84693.85
5173270-17327093.98093.98
6175139-17513994.99494.99
20min1169028-16902891.67992.761.4091.6892.761.40
2169119-16911991.72991.73
3168453-16845391.36791.37
4173264-17326493.97793.98
5173499-17349994.10494.10
6172754-17275493.70093.70
30min1171138-17113892.82493.851.3092.8293.851.30
2174078-17407894.41894.42
3169519-16951991.94591.95
4173806-17380694.27194.27
5173954-17395494.35194.35
6175640-17564095.26595.27
45min1171975-17197593.27894.091.2993.2894.091.29
2174482-17448294.63794.64
3169662-16966292.02392.02
4174259-17425994.51694.52
5174977-17497794.90694.91
6175473-17547395.17595.17
60min1171339-17133992.93394.021.2592.9394.021.25
2174777-17477794.79794.80
3170358-17035892.40192.40
4173791-17379194.26394.26
5173579-17357994.14894.15
6176170-17617095.55395.55
极限1172271-17227193.43893.981.0193.4493.981.01
2172663-17266393.65193.65
3170913-17091392.70292.70
4174606-17460694.70594.70
5173361-17336194.02994.03
6175829-17582995.36895.37
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%
114.151834701833211832451832371830661832680.08
214.161846871846541846700.02
单位质量响应值RSD%判断
12951.8013041.670.49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%
2min1134652-13465273.23169.924.2673.2369.924.26
2130150-13015070.78370.78
3126105-12610568.58368.58
4122910-12291066.84566.85
5122801-12280166.78666.79
6134817-13481773.32173.32
5min1170171-17017192.54893.250.9592.5593.250.95
2169014-16901491.91991.92
3172982-17298294.07794.08
4172499-17249993.81593.81
5172886-17288694.02594.03
6171239-17123993.12993.13
10min1172070-17207093.58194.511.1593.5894.511.14
2171599-17159993.32593.33
3172527-17252793.83093.83
4175271-17527195.32295.32
5176504-17650495.99395.99
6174654-17465494.98794.99
15min1172411-17241193.76794.971.2893.7794.971.28
2171339-17133993.18493.18
3176100-17610095.77395.77
4175500-17550095.44795.45
5177022-17702296.27496.27
6175333-17533395.35695.36
20min1171385-17138593.20994.921.6193.2194.921.60
2170626-17062692.79692.80
3176940-17694096.23096.23
4175567-17556795.48395.48
5176908-17690896.21296.21
6175715-17571595.56495.56
30min1171059-17105993.03195.291.8993.0395.281.89
2170953-17095392.97492.97
3177383-17738396.47196.47
4177184-17718496.36396.36
5178140-17814096.88296.88
6176525-17652596.00496.00
45min1174078-17407894.67395.831.4294.6795.831.42
2172179-17217993.64193.64
3178392-17839297.02097.02
4177985-17798596.79896.80
5177625-17762596.60296.60
6176943-17694396.23196.23
60min1173286-17328694.24395.701.5494.2495.701.54
2172112-17211293.60493.60
3178151-17815196.88896.89
4176141-17614195.79595.80
5178783-17878397.23297.23
6177275-17727596.41296.41
极限1174721-17472195.02396.061.2295.0296.061.23
2173176-17317694.18394.18
3177948-17794896.77896.78
4177913-17791396.75996.76
5178445-17844597.04897.05
6177595-17759596.58696.59
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