氢溴酸氟硫西汀口崩片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号171336-202301对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数0.7867
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.781736791736921738251733481736631736410.11
213.831742361738801740580.15
单位质量响应值RSD%判断
12600.9412585.540.09数据可信
加速6月-供试品溶液-2025102321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%
2min1105199-10519959.08759.558.8159.0959.558.81
2103714-10371458.25358.25
398702-9870255.43855.44
4123632-12363269.44069.44
5106924-10692460.05660.06
697945-9794555.01355.01
5min1169699-16969995.31594.092.7595.3194.092.75
2164674-16467492.49292.49
3159640-15964089.66589.66
4168318-16831894.53994.54
5171475-17147596.31296.31
6171321-17132196.22696.23
10min1176870-17687099.342100.432.2199.34100.432.21
2177698-17769899.80799.81
3186356-186356104.670104.67
4175333-17533398.47998.48
5176991-17699199.41099.41
6179631-179631100.893100.89
15min1178477-178477100.245100.370.52100.24100.370.52
2178206-178206100.093100.09
3179953-179953101.074101.07
4177339-17733999.60699.61
5178844-178844100.451100.45
6179390-179390100.758100.76
20min1176943-17694399.38399.691.1399.3899.691.12
2178817-178817100.436100.44
3178756-178756100.402100.40
4174048-17404897.75797.76
5176893-17689399.35599.36
6179464-179464100.799100.80
30min1178433-178433100.220100.101.01100.22100.101.01
2178419-178419100.212100.21
3179510-179510100.825100.83
4175965-17596598.83498.83
5176356-17635699.05499.05
6180612-180612101.444101.44
45min1178211-178211100.09599.362.03100.1099.362.03
2179246-179246100.677100.68
3179067-179067100.576100.58
4170757-17075795.90995.91
5174373-17437397.94097.94
6179786-179786100.980100.98
60min1178328-178328100.161100.280.64100.16100.280.64
2179286-179286100.699100.70
3179233-179233100.669100.67
4176864-17686499.33999.34
5177661-17766199.78799.79
6179848-179848101.015101.01
极限1180570-180570101.42099.171.84101.4299.171.84
2178794-178794100.423100.42
3173722-17372297.57497.57
4178327-178327100.161100.16
5172110-17211096.66996.67
6175874-17587498.78398.78
氢溴酸氟硫西汀口崩片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号171336-202301对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数0.7867
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.781740461737091736791739461736461738050.11
213.831740221743621741920.14
单位质量响应值RSD%判断
12612.8412595.230.10数据可信
加速6月-供试品溶液-2025102421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%
2min1110263-11026361.87863.052.4561.8863.052.44
2114236-11423664.10864.11
3108660-10866060.97960.98
4114667-11466764.35064.35
5115311-11531164.71164.71
6110955-11095562.26762.27
5min1166469-16646993.42093.740.8793.4293.740.87
2166466-16646693.41993.42
3164696-16469692.42592.43
4167819-16781994.17894.18
5168334-16833494.46794.47
6168432-16843294.52294.52
10min1175275-17527598.36295.895.3798.3695.895.36
2174334-17433497.83497.83
3176800-17680099.21899.22
4176222-17622298.89498.89
5169665-16966595.21495.21
6152903-15290385.80785.81
15min1181321-181321101.755100.301.62101.76100.301.62
2182485-182485102.408102.41
3175496-17549698.48698.49
4176388-17638898.98798.99
5176847-17684799.24499.24
6179855-179855100.932100.93
20min1177361-17736199.53399.440.3799.5399.440.37
2176821-17682199.23099.23
3176373-17637398.97898.98
4178300-178300100.060100.06
5177055-17705599.36199.36
6177293-17729399.49599.49
30min1176733-17673399.18099.771.0099.1899.781.00
2180825-180825101.477101.48
3176424-17642499.00799.01
4176422-17642299.00699.01
5177380-17738099.54399.54
6178954-178954100.427100.43
45min1176751-17675199.19099.450.3199.1999.450.30
2177503-17750399.61299.61
3177891-17789199.83099.83
4176690-17669099.15699.16
5176766-17676699.19999.20
6177643-17764399.69199.69
60min1176679-17667999.15099.180.2399.1599.180.23
2177141-17714199.40999.41
3176210-17621098.88798.89
4176347-17634798.96498.96
5177185-17718599.43499.43
6176852-17685299.24799.25
极限1177452-17745299.58499.370.6399.5899.370.63
2177195-17719599.44099.44
3175636-17563698.56598.56
4176105-17610598.82898.83
5178782-178782100.330100.33
6177300-17730099.49899.50
氢溴酸氟硫西汀口崩片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号171336-202301对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数0.7867
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.781751731750881748721751861749871750610.08
213.831751901753091752500.05
单位质量响应值RSD%判断
12703.9912671.730.18数据可信
加速6月-供试品溶液-2025102521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%
2min1112101-11210162.49460.2811.3762.4960.2811.37
2103331-10333157.60557.60
385985-8598547.93547.93
4111885-11188562.37462.37
5114013-11401363.56063.56
6121445-12144567.70367.70
5min1168750-16875094.07592.941.9694.0792.941.96
2165582-16558292.30992.31
3163122-16312290.93790.94
4163612-16361291.21091.21
5167478-16747893.36693.37
6171694-17169495.71695.72
10min1177992-17799299.22799.131.3399.2399.131.33
2178072-17807299.27299.27
3179106-17910699.84899.85
4173968-17396896.98496.98
5176813-17681398.57098.57
6180986-180986100.896100.90
15min1179335-17933599.97698.581.6199.9898.581.61
2179829-179829100.251100.25
3178106-17810699.29199.29
4172848-17284896.35996.36
5174058-17405897.03497.03
6176854-17685498.59398.59
20min1178598-17859899.56599.791.1699.5699.791.16
2178378-17837899.44299.44
3182021-182021101.473101.47
4175745-17574597.97497.97
5179206-17920699.90499.90
6180088-180088100.396100.40
30min1178978-17897899.77798.962.7399.7898.962.73
2178084-17808499.27899.28
3170895-17089595.27195.27
4174563-17456397.31597.32
5177140-17714098.75298.75
6185377-185377103.344103.34
45min1177890-17789099.17099.531.2299.1799.521.22
2180147-180147100.428100.43
3177949-17794999.20399.20
4175563-17556397.87397.87
5177781-17778199.10999.11
6181842-181842101.373101.37
60min1181226-181226101.03099.981.30101.0399.981.31
2180059-180059100.379100.38
3177779-17777999.10899.11
4175617-17561797.90397.90
5179419-179419100.023100.02
6181941-181941101.429101.43
极限1179434-179434100.03199.251.10100.0399.251.10
2178285-17828599.39099.39
3176599-17659998.45098.45
4175048-17504897.58697.59
5178360-17836099.43299.43
6180449-180449100.597100.60
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