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%
111.725188695186585187975189275191345188770.04
211.725214585215325214950.02
单位质量响应值RSD%判断
44272.7844496.160.36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%
5min1376985-37698568.24961.2110.4468.2561.2110.44
2322024-32202458.29958.30
3305613-30561355.32855.33
4324793-32479358.80058.80
5388078-38807870.25770.26
6311171-31117156.33456.33
10min1505597-50559791.53394.802.6792.2995.482.66
2537325-53732597.27797.92
3509327-50932792.20892.82
4533508-53350896.58697.24
5535850-53585097.01097.79
6520412-52041294.21594.84
15min1560781-560781101.52499.192.67103.30100.932.68
2562231-562231101.786103.51
3525944-52594495.21796.86
4548657-54865799.329101.06
5554746-554746100.431102.29
6535068-53506896.86998.54
20min1561751-561751101.69998.543.16104.60101.373.16
2555067-555067100.489103.35
3519872-51987294.11796.81
4549193-54919399.426102.26
5553866-553866100.272103.25
6525910-52591095.21197.96
30min1567678-567678102.77299.142.54106.81103.072.54
2551679-55167999.876103.85
3539604-53960497.690101.43
4546043-54604398.855102.79
5553935-553935100.284104.37
6526727-52672795.35899.17
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%
111.725199045199375201445202425202735201000.04
211.725193355193995193670.01
单位质量响应值RSD%判断
44377.1344314.590.10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%
5min1345240-34524062.55664.8210.1962.5664.8210.18
2319631-31963157.91657.92
3425398-42539877.08077.08
4339520-33952061.52061.52
5365739-36573966.27166.27
6350721-35072163.54963.55
10min1485528-48552887.97696.154.9388.6796.864.89
2521565-52156594.50695.15
3524516-52451695.04095.90
4554904-554904100.546101.23
5545147-54514798.77999.51
6552036-552036100.027100.73
15min1509402-50940292.30296.983.4193.9798.773.38
2529039-52903995.86097.55
3522550-52255094.68496.60
4558006-558006101.109102.91
5542338-54233898.270100.10
6550091-55009199.674101.49
20min1512256-51225692.81996.133.0495.5299.003.02
2519885-51988594.20196.96
3519296-51929694.09497.06
4554901-554901100.546103.47
5537346-53734697.365100.29
6539627-53962797.778100.70
30min1505069-50506991.51795.553.2795.2599.483.25
2516686-51668693.62297.43
3520986-52098694.40198.41
4551757-55175799.976104.02
5542710-54271098.337102.34
6526706-52670695.43799.45
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%
111.725194855194125191635193075193595193450.03
211.725235415235165235280.01
单位质量响应值RSD%判断
44312.7144669.620.57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%
5min1270989-27098948.94362.3210.9148.9462.3210.91
2359854-35985464.99264.99
3361707-36170765.32765.33
4342621-34262161.88061.88
5373733-37373367.49967.50
6361331-36133165.25965.26
10min1502110-50211090.68592.793.6591.2393.493.66
2490535-49053588.59489.32
3528299-52829995.41596.14
4507557-50755791.66892.36
5542549-54254997.98898.74
6511695-51169592.41693.14
15min1503391-50339190.91693.253.5292.4794.973.53
2491876-49187688.83690.54
3528951-52895195.53297.32
4512400-51240092.54394.25
5542802-54280298.03499.87
6518331-51833193.61495.37
20min1503586-50358690.95192.753.0793.5195.513.09
2490750-49075088.63391.33
3524539-52453994.73697.58
4509782-50978292.07094.80
5535117-53511796.64699.57
6517636-51763693.48996.28
30min1494101-49410189.23891.543.6192.8195.333.61
2481220-48122086.91290.59
3522057-52205794.28798.19
4499658-49965890.24294.00
5529275-52927595.59199.59
6514886-51488692.99296.82
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