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%
111.725155575155765154675152765152125154180.04
211.725144245150035147140.08
单位质量响应值RSD%判断
43977.6543917.580.10数据可信
供试品溶液-2022042701批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1330577-33057760.44257.0217.2960.4457.0217.29
2360982-36098266.00166.00
3346601-34660163.37263.37
4215177-21517739.34339.34
5333339-33333960.94760.95
6284454-28445452.00952.01
10min1494507-49450790.41595.052.9291.0995.682.87
2530887-53088797.06697.80
3513245-51324593.84194.54
4533538-53353897.55197.99
5531502-53150297.17997.86
6515481-51548194.25094.83
15min1503214-50321492.00795.762.5093.6897.452.46
2535391-53539197.89099.70
3515171-51517194.19395.94
4533852-53385297.60999.13
5534191-53419197.67199.43
6520589-52058995.18496.81
20min1497753-49775391.00894.852.4193.7197.602.37
2524091-52409195.82498.72
3512374-51237493.68296.47
4529050-52905096.73199.34
5531429-53142997.166100.01
6517936-51793694.69897.38
30min1491533-49153389.87193.422.5993.5897.222.54
2518773-51877394.85298.82
3499190-49919091.27195.11
4523024-52302495.62999.31
5523204-52320495.66299.58
6509768-50976893.20596.94
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%
111.725145625144565153495152185152405149650.09
211.725168925184695176800.22
单位质量响应值RSD%判断
43938.9944170.650.38数据可信
供试品溶液-2022042801批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1374211-37421168.25460.5010.6268.2560.5010.61
2329904-32990460.17360.17
3284977-28497751.97851.98
4301575-30157555.00655.01
5367654-36765467.05867.06
6331738-33173860.50760.51
10min1533122-53312297.23894.993.8798.0095.663.90
2532624-53262497.14897.82
3481905-48190587.89788.47
4516875-51687594.27594.89
5533957-53395797.39198.14
6526254-52625495.98696.66
15min1550081-550081100.33296.792.60102.1798.522.63
2543141-54314199.066100.81
3511819-51181993.35394.91
4528326-52832696.36498.02
5524676-52467695.69897.53
6525983-52598395.93697.68
20min1531725-53172596.98495.413.5399.9498.223.54
2525500-52550095.84898.70
3487345-48734588.88991.48
4531783-53178396.99499.72
5539493-53949398.401101.29
6522893-52289395.37398.18
30min1531877-53187797.01192.775.62101.0496.645.51
2517065-51706594.31098.22
3488791-48879189.15392.73
4459770-45977083.85987.67
5528868-52886896.463100.45
6525409-52540995.83299.70
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%
111.725155065153515146255147045149765150320.08
211.725157885153555155720.06
单位质量响应值RSD%判断
43944.7143990.780.08数据可信
供试品溶液-2022050701批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1290649-29064953.11757.9920.4453.1257.9920.44
2316602-31660257.86057.86
3379839-37983969.41769.42
4359875-35987565.76965.77
5354442-35444264.77664.78
6202351-20235136.98136.98
10min1519974-51997495.02893.992.6095.6294.632.66
2508386-50838692.91093.55
3518091-51809194.68395.45
4507124-50712492.67993.41
5535403-53540397.84798.57
6496725-49672590.77991.19
15min1505276-50527692.34194.303.0193.9995.993.07
2501626-50162691.67493.35
3526717-52671796.26098.08
4518892-51889294.83096.59
5540316-54031698.745100.55
6503241-50324191.97093.39
20min1512016-51201693.57393.903.0296.2596.643.08
2502188-50218891.77794.47
3525942-52594296.11899.01
4507866-50786692.81595.63
5538106-53810698.341101.25
6496867-49686790.80593.25
30min1520981-52098195.21294.092.9698.9297.873.01
2505106-50510692.31096.02
3527303-52730396.367100.33
4502246-50224691.78895.63
5535519-53551997.868101.87
6497960-49796091.00494.45
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