盐酸氟西汀胶囊项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100513-202203对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数1000
标示量(mg)20供试品稀释倍数2系数0.8946
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.725149915154515154875158835157295155080.07
211.725180745178625179680.03
单位质量响应值RSD%判断
43985.3244195.220.34数据可信
供试品溶液-2022042701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%
5min1357325-35732565.12261.9013.1665.1261.9013.15
2366736-36673666.83766.84
3398913-39891372.70172.70
4283513-28351351.67051.67
5292049-29204953.22553.23
6339463-33946361.86661.87
10min1501046-50104691.31495.703.6592.0496.383.62
2515070-51507093.87094.61
3552583-552583100.707101.51
4540513-54051398.50799.08
5528561-52856196.32996.92
6512846-51284693.46594.15
15min1508803-50880392.72896.303.4594.4798.053.43
2519316-51931694.64496.43
3557187-557187101.546103.47
4536682-53668297.80999.48
5535505-53550597.59499.26
6512847-51284793.46595.19
20min1508703-50870392.71096.143.0595.4898.963.03
2520524-52052494.86497.70
3548275-54827599.922102.98
4540760-54076098.552101.31
5534416-53441697.396100.14
6512325-51232593.37096.13
30min1501555-50155591.40796.073.6095.2199.963.55
2520847-52084794.92398.81
3549454-549454100.137104.30
4543300-54330099.015102.87
5536369-53636997.752101.58
6511249-51124993.17496.98
盐酸氟西汀胶囊项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100513-202203对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数1000
标示量(mg)20供试品稀释倍数2系数0.8946
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.725168455169405170575170245167805169290.03
211.725158625158455158540.01
单位质量响应值RSD%判断
44106.5744014.850.15数据可信
供试品溶液-2022042801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%
5min1425382-42538277.57671.3812.5777.5871.3812.58
2433572-43357279.07079.07
3351620-35162064.12564.12
4314378-31437857.33357.33
5391376-39137671.37571.37
6432075-43207578.79778.80
10min1536087-53608797.76694.994.1398.6395.784.14
2503311-50331191.78892.67
3509596-50959692.93493.65
4498125-49812590.84391.48
5554347-554347101.096101.89
6523724-52372495.51196.39
15min1549396-549396100.19395.864.39102.1497.714.41
2514364-51436493.80495.70
3512013-51201393.37595.12
4495556-49555690.37492.02
5555101-555101101.233103.15
6527526-52752696.20498.14
20min1552100-552100100.68696.394.09103.7599.304.11
2517106-51710694.30497.24
3523365-52336595.44698.23
4498059-49805990.83193.48
5554689-554689101.158104.20
6525980-52598095.92298.93
30min1546054-54605499.58395.723.66103.7699.703.69
2515493-51549394.01098.00
3519630-51963094.76498.61
4498248-49824890.86594.52
5548347-548347100.001104.17
6521438-52143895.09499.17
盐酸氟西汀胶囊项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100513-202203对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数1000
标示量(mg)20供试品稀释倍数2系数0.8946
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.725159755159435161145156835159055159240.04
211.725173655176915175280.05
单位质量响应值RSD%判断
44020.8244157.680.22数据可信
供试品溶液-2022050701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%
5min1327180-32718059.62964.566.4559.6364.566.45
2353968-35396864.51164.51
3327858-32785859.75259.75
4366332-36633266.76466.76
5366160-36616066.73366.73
6384023-38402369.98969.99
10min1512279-51227993.36394.852.5694.0395.562.57
2525190-52519095.71696.43
3504598-50459891.96492.63
4513723-51372393.62794.37
5542531-54253198.87799.62
6524191-52419195.53496.31
15min1515730-51573093.99295.432.5995.6997.202.60
2533236-53323697.18398.96
3507896-50789692.56594.25
4512870-51287093.47195.25
5542798-54279898.926100.77
6529277-52927796.46198.30
20min1524831-52483195.65194.562.1998.4097.392.19
2529046-52904696.41999.28
3501436-50143691.38794.10
4507703-50770392.52995.35
5525042-52504295.69098.63
6524990-52499095.68098.59
30min1504506-50450691.94793.782.6395.7597.662.62
2515516-51551693.95397.88
3505830-50583092.18895.92
4504104-50410491.87495.72
5539336-53933698.295102.30
6518125-51812594.42998.40
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