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%
111.725125135126805119225122655121065122970.06
211.725158195155535156860.04
单位质量响应值RSD%判断
43711.3544000.510.47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%
5min1309362-30936256.68263.4413.6556.6863.4413.65
2332134-33213460.85460.85
3284164-28416452.06552.07
4406485-40648574.47774.48
5391693-39169371.76771.77
6353624-35362464.79264.79
10min1526762-52676296.51596.431.8997.1497.141.97
2518297-51829794.96495.64
3512000-51200093.81094.39
4532922-53292297.64398.47
5539661-53966198.87899.68
6528132-52813296.76697.49
15min1527105-52710596.57796.762.0498.2898.542.11
2524311-52431196.06597.80
3509260-50926093.30894.93
4533987-53398797.83899.75
5539525-53952598.853100.75
6534562-53456297.94499.74
20min1522175-52217595.67496.042.1798.4598.902.24
2519358-51935895.15897.96
3507022-50702292.89895.56
4532797-53279797.620100.62
5539896-53989698.921101.92
6523803-52380395.97298.86
30min1521586-52158695.56695.362.6499.4099.282.69
2511084-51108493.64297.50
3499232-49923291.47095.16
4531439-53143997.371101.46
5537157-53715798.419102.51
6522244-52224495.68799.64
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%
111.725124635124035126225128705126205125960.04
211.725150885155115153000.06
单位质量响应值RSD%判断
43736.8643967.580.38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%
5min1358060-35806065.61069.6514.3565.6169.6514.35
2343825-34382563.00163.00
3447714-44771482.03882.04
4451636-45163682.75682.76
5332256-33225660.88260.88
6347257-34725763.63063.63
10min1519668-51966895.22294.182.5495.9594.962.62
2508815-50881593.23493.93
3519005-51900595.10196.01
4534530-53453097.94698.87
5502381-50238192.05592.73
6499538-49953891.53492.24
15min1524267-52426796.06595.242.1297.8597.062.18
2502872-50287292.14593.88
3525965-52596596.37698.34
4533445-53344597.74799.75
5511427-51142793.71295.41
6520581-52058195.39097.11
20min1523247-52324795.87894.872.4198.7397.752.47
2508375-50837593.15395.91
3518217-51821794.95798.00
4539347-53934798.828101.92
5505082-50508292.55095.29
6512202-51220293.85496.64
30min1517174-51717494.76595.192.3098.6999.122.38
2504784-50478492.49596.29
3529113-52911396.953101.05
4537675-53767598.522102.71
5512208-51220893.85697.62
6516041-51604194.55898.38
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%
111.725153765152775152575151285147965151670.05
211.725154535156425155480.03
单位质量响应值RSD%判断
43956.2343988.740.06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%
5min1373244-37324468.20559.0118.0968.2059.0018.09
2344321-34432162.91962.92
3215350-21535039.35239.35
4299777-29977754.78054.78
5341960-34196062.48862.49
6362780-36278066.29266.29
10min1524659-52465995.87390.394.1196.6391.044.20
2492414-49241489.98190.68
3462297-46229784.47884.91
4488336-48833689.23689.84
5498395-49839591.07491.77
6501861-50186191.70792.44
15min1538972-53897298.48993.053.06100.3194.713.07
2501825-50182591.70193.40
3510012-51001293.19794.57
4494089-49408990.28791.89
5503455-50345591.99993.70
6506923-50692392.63294.39
20min1536958-53695898.12193.512.63101.0496.212.65
2504981-50498192.27895.00
3514074-51407493.93996.35
4498000-49800091.00293.61
5509045-50904593.02095.75
6507303-50730392.70295.49
30min1534315-53431597.63893.442.51101.6597.182.53
2504938-50493892.27096.01
3515202-51520294.14597.60
4496803-49680390.78394.40
5506355-50635592.52996.29
6510563-51056393.29897.11
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