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%
111.725093855088535078945083765088515086720.12
211.725110315113335111820.05
单位质量响应值RSD%判断
43402.0543616.210.35数据可信
供试品溶液-2022042701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%
5min1405468-40546874.88368.7213.0674.8868.7213.06
2344073-34407363.54463.54
3400832-40083274.02674.03
4379863-37986370.15470.15
5287396-28739653.07753.08
6415042-41504276.65176.65
10min1532629-53262998.36797.901.3599.2098.661.43
2521310-52131096.27696.98
3537585-53758599.282100.10
4532450-53245098.33499.11
5521152-52115296.24796.84
6535341-53534198.86899.72
15min1532789-53278998.39698.720.93100.32100.570.97
2529922-52992297.86799.64
3541258-54125899.961101.89
4540275-54027599.779101.65
5530694-53069498.01099.67
6532298-53229898.306100.26
20min1547923-547923101.19198.851.60104.21101.791.62
2530662-53066298.004100.87
3535704-53570498.935101.97
4542615-542615100.211103.19
5526605-52660597.254100.00
6527824-52782497.480100.52
30min1544648-544648100.58798.462.13104.73102.512.17
2524222-52422296.814100.77
3535822-53582298.957103.09
4537729-53772999.309103.40
5514957-51495795.10398.93
6541477-541477100.001104.13
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%
111.725139275144685145985146465150245145330.08
211.725161385164785163080.05
单位质量响应值RSD%判断
43902.1344053.580.25数据可信
供试品溶液-2022042801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%
5min1333704-33370460.97268.769.0460.9768.769.04
2359639-35963965.71165.71
3394875-39487572.14972.15
4355316-35531664.92164.92
5384771-38477170.30370.30
6429503-42950378.47678.48
10min1536906-53690698.100101.474.0498.78102.234.02
2549439-549439100.390101.12
3578647-578647105.726106.53
4540945-54094598.83899.56
5588143-588143107.461108.24
6537916-53791698.28499.16
15min1543779-54377999.355100.703.04101.12102.603.02
2559754-559754102.274104.12
3569643-569643104.081106.06
4535925-53592597.92099.74
5567494-567494103.688105.66
6530388-53038896.90998.87
20min1539999-53999998.665100.191.73101.54103.201.77
2541088-54108898.864101.85
3563529-563529102.964106.10
4545001-54500199.579102.49
5556365-556365101.655104.78
6543950-54395099.387102.43
30min1541296-54129698.902100.061.70102.87104.181.74
2536533-53653398.031102.11
3562625-562625102.799107.08
4543378-54337899.282103.30
5552389-552389100.929105.19
6549520-549520100.404104.55
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%
111.725204325204565187405184565183625192890.21
211.725167635170705169160.05
单位质量响应值RSD%判断
44307.9444105.460.33数据可信
供试品溶液-2022050701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%
5min1227686-22768641.38662.3520.4541.3962.3520.44
2352640-35264064.09864.10
3387647-38764770.46270.46
4426935-42693577.60377.60
5300847-30084754.68454.68
6362472-36247265.88665.89
10min1496845-49684590.31094.522.5990.7795.222.64
2531537-53153796.61697.33
3517776-51777694.11594.90
4515262-51526293.65894.52
5525679-52567995.55196.16
6533085-53308596.89897.63
15min1510155-51015592.73095.111.7494.1996.851.79
2533575-53357596.98798.77
3516198-51619893.82895.66
4520624-52062494.63396.54
5528178-52817896.00697.67
6530664-53066496.45798.27
20min1506491-50649192.06494.391.4794.5697.201.53
2525293-52529395.48198.34
3520192-52019294.55497.43
4514126-51412693.45196.41
5524750-52475095.38298.12
6525016-52501695.43198.31
30min1501027-50102791.07093.671.9894.5997.521.98
2521109-52110994.72198.64
3512487-51248793.15397.08
4507540-50754092.25496.25
5528701-52870196.10199.90
6521142-52114294.72798.67
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