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%
114.221799771798311798141797321800961798900.09
214.221779301775821777560.14
单位质量响应值RSD%判断
12650.4912500.420.85数据可信
加速3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%
2min1113254-11325463.70362.455.3863.7062.455.38
2109051-10905161.33961.34
3105072-10507259.10159.10
4105289-10528959.22359.22
5120928-12092868.02068.02
6112596-11259663.33363.33
5min1169701-16970195.45494.982.0195.4594.982.01
2167340-16734094.12694.13
3168020-16802094.50894.51
4174214-17421497.99297.99
5163960-16396092.22592.22
6169899-16989995.56595.57
10min1174479-17447998.14198.591.6598.1498.591.65
2174148-17414897.95597.96
3175909-17590998.94698.95
4179947-179947101.217101.22
5171160-17116096.27496.27
6175967-17596798.97898.98
15min1175231-17523198.56498.521.4498.5698.521.44
2174464-17446498.13398.13
3175167-17516798.52898.53
4178535-178535100.423100.42
5170943-17094396.15296.15
6176579-17657999.32399.32
20min1173747-17374797.73098.412.1097.7398.412.10
2173176-17317697.40897.41
3173307-17330797.48297.48
4179650-179650101.050101.05
5170546-17054695.92995.93
6179271-179271100.837100.84
30min1174941-17494198.40199.322.0798.4099.322.07
2180968-180968101.791101.79
3176017-17601799.00699.01
4178685-178685100.507100.51
5170518-17051895.91395.91
6178321-178321100.302100.30
45min1176318-17631899.17698.171.4199.1898.171.41
2174277-17427798.02898.03
3173241-17324197.44597.44
4177360-17736099.76299.76
5170504-17050495.90595.91
6175455-17545598.69098.69
60min1181008-181008101.81498.692.12101.8198.692.12
2175186-17518698.53998.54
3173684-17368497.69497.69
4177342-17734299.75299.75
5169895-16989595.56395.56
6175644-17564498.79798.80
极限1173665-17366597.68397.731.4397.6897.731.43
2172751-17275197.16997.17
3173320-17332097.48997.49
4177331-17733199.74699.75
5170013-17001395.62995.63
6175371-17537198.64398.64
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%
114.221775861777211779171776631779701777710.10
214.221774591775681775140.05
单位质量响应值RSD%判断
12501.4812483.400.11数据可信
加速3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%
2min1117978-11797866.79966.478.5766.8066.478.57
2125435-12543571.02171.02
3117471-11747166.51266.51
497903-9790355.43355.43
5123801-12380170.09670.10
6121795-12179568.96068.96
5min1165691-16569193.81493.901.1993.8193.901.19
2164145-16414592.93992.94
3164750-16475093.28193.28
4167339-16733994.74794.75
5169030-16903095.70595.70
6164141-16414192.93792.94
10min1171832-17183297.29198.942.0697.2998.942.06
2172905-17290597.89997.90
3180870-180870102.409102.41
4177096-177096100.272100.27
5174054-17405498.54998.55
6171702-17170297.21897.22
15min1171283-17128396.98098.141.2696.9898.141.25
2172288-17228897.55097.55
3172372-17237297.59797.60
4176674-176674100.033100.03
5175409-17540999.31799.32
6171998-17199897.38597.39
20min1177259-177259100.36498.801.32100.3698.801.32
2171794-17179497.27097.27
3173771-17377198.38998.39
4176704-176704100.050100.05
5175242-17524299.22299.22
6172173-17217397.48497.48
30min1171054-17105496.85198.381.4996.8598.381.49
2172186-17218697.49297.49
3173020-17302097.96497.96
4177641-177641100.580100.58
5176246-17624699.79199.79
6172391-17239197.60897.61
45min1170929-17092996.78098.011.4396.7898.011.43
2171125-17112596.89196.89
3172971-17297197.93697.94
4176855-176855100.135100.14
5175270-17527099.23899.24
6171431-17143197.06497.06
60min1170833-17083396.72698.321.3396.7398.321.33
2171212-17121296.94096.94
3173428-17342898.19598.19
4176714-176714100.056100.06
5174952-17495299.05899.06
6174790-17479098.96698.97
极限1171909-17190997.33598.711.5597.3398.711.55
2172146-17214697.46997.47
3171994-17199497.38397.38
4176592-17659299.98699.99
5175305-17530599.25899.26
6178062-178062100.819100.82
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%
114.221765991769881770261767541769241768580.11
214.221773741775201774470.06
单位质量响应值RSD%判断
12437.2712478.690.24数据可信
加速3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%
2min1129975-12997573.79667.475.5173.8067.475.52
2123311-12331170.01270.01
3116401-11640166.08966.09
4113722-11372264.56864.57
5113129-11312964.23164.23
6116468-11646866.12766.13
5min1177182-177182100.59896.422.48100.6096.422.48
2171015-17101597.09797.10
3165707-16570794.08394.08
4167336-16733695.00895.01
5166865-16686594.74194.74
6170818-17081896.98596.98
10min1180110-180110102.261100.501.10102.26100.501.10
2177404-177404100.724100.72
3174478-17447899.06399.06
4176540-176540100.234100.23
5177834-177834100.968100.97
6175677-17567799.74499.74
15min1180199-180199102.311100.531.36102.31100.521.36
2177490-177490100.773100.77
3174790-17479099.24099.24
4179376-179376101.844101.84
5174388-17438899.01299.01
6176100-17610099.98499.98
20min1181393-181393102.989100.571.37102.99100.581.36
2177916-177916101.015101.01
3175226-17522699.48899.49
4176005-17600599.93099.93
5174837-17483799.26799.27
6177465-177465100.759100.76
30min1182089-182089103.384100.751.55103.38100.751.55
2179471-179471101.898101.90
3176458-176458100.187100.19
4175361-17536199.56499.56
5175389-17538999.58099.58
6175974-17597499.91299.91
45min1180887-180887102.702100.431.25102.70100.431.25
2177698-177698100.891100.89
3175172-17517299.45799.46
4176342-176342100.121100.12
5174847-17484799.27299.27
6176405-176405100.157100.16
60min1180517-180517102.492100.241.25102.49100.241.25
2177510-177510100.784100.78
3174873-17487399.28799.29
4174969-17496999.34299.34
5175121-17512199.42899.43
6176267-176267100.079100.08
极限1181058-181058102.799100.831.43102.80100.831.42
2177353-177353100.695100.70
3174853-17485399.27699.28
4179135-179135101.707101.71
5174592-17459299.12899.13
6178524-178524101.360101.36
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%
114.221776101772111777601779561775441776160.16
214.221773911777011775460.13
单位质量响应值RSD%判断
12490.5812485.650.03数据可信
中间条件3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%
2min1114032-11403264.58763.472.9564.5963.472.95
2111346-11134663.06663.07
3109542-10954262.04462.04
4117805-11780566.72466.72
5110247-11024762.44362.44
6109361-10936161.94261.94
5min1167812-16781295.04894.181.1995.0594.181.19
2167481-16748194.86194.86
3163399-16339992.54992.55
4167755-16775595.01695.02
5164148-16414892.97392.97
6167038-16703894.61094.61
10min1175789-17578999.56699.242.2899.5799.242.28
2173493-17349398.26698.27
3172095-17209597.47497.47
4176093-17609399.73899.74
5171460-17146097.11497.11
6182389-182389103.304103.30
15min1175640-17564099.48299.611.8399.4899.621.84
2175275-17527599.27599.28
3182202-182202103.199103.20
4174873-17487399.04799.05
5173310-17331098.16298.16
6173944-17394498.52198.52
20min1175833-17583399.59198.660.6199.5998.660.60
2174723-17472398.96298.96
3173487-17348798.26298.26
4174356-17435698.75598.75
5172821-17282197.88597.89
6173886-17388698.48898.49
30min1176581-176581100.01599.500.90100.0199.500.90
2176634-176634100.045100.04
3177766-177766100.686100.69
4175136-17513699.19699.20
5173842-17384298.46398.46
6174036-17403698.57398.57
45min1176378-17637899.90099.060.5899.9099.060.58
2175173-17517399.21799.22
3173424-17342498.22798.23
4175196-17519699.23099.23
5174146-17414698.63698.64
6175014-17501499.12799.13
60min1176065-17606599.72399.660.7499.7299.660.74
2177310-177310100.428100.43
3176484-17648499.96099.96
4176554-17655499.999100.00
5173541-17354198.29398.29
6175808-17580899.57799.58
极限1178481-178481101.09199.201.11101.0999.201.11
2176173-17617399.78499.78
3174033-17403398.57298.57
4175104-17510499.17899.18
5173444-17344498.23898.24
6173583-17358398.31798.32
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%
114.221775611772801773771774461777491774830.11
214.221784561784931784740.02
单位质量响应值RSD%判断
12481.2212550.910.40数据可信
中间条件3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%
2min1107168-10716860.56462.234.3860.5662.234.38
2106454-10645460.16160.16
3108039-10803961.05761.06
4106957-10695760.44560.45
5113882-11388264.35964.36
6118200-11820066.79966.80
5min1163196-16319692.22893.071.5392.2393.061.53
2164582-16458293.01193.01
3168653-16865395.31295.31
4166100-16610093.86993.87
5161331-16133191.17491.17
6164210-16421092.80192.80
10min1170904-17090496.58497.411.8796.5897.411.86
2171724-17172497.04797.05
3173555-17355598.08298.08
4178213-178213100.714100.71
5169141-16914195.58895.59
6170667-17066796.45096.45
15min1171464-17146496.90097.281.2696.9097.281.26
2171981-17198197.19397.19
3174147-17414798.41798.42
4175038-17503898.92098.92
5169063-16906395.54395.54
6171107-17110796.69996.70
20min1172357-17235797.40598.542.3997.4198.542.39
2180981-180981102.279102.28
3174875-17487598.82898.83
4177013-177013100.036100.04
5169700-16970095.90395.90
6171288-17128896.80196.80
30min1172429-17242997.44697.761.1997.4597.761.19
2173078-17307897.81397.81
3175135-17513598.97598.98
4175441-17544199.14899.15
5170061-17006196.10896.11
6171788-17178897.08397.08
45min1170076-17007696.11697.411.6596.1297.411.65
2173267-17326797.91997.92
3175801-17580199.35199.35
4174976-17497698.88598.89
5168468-16846895.20795.21
6171608-17160896.98296.98
60min1172228-17222897.33298.001.8597.3398.001.85
2175754-17575499.32599.32
3178640-178640100.956100.96
4172669-17266997.58197.58
5170103-17010396.13196.13
6171101-17110196.69596.70
极限1172440-17244097.45298.501.9697.4598.501.96
2174890-17489098.83798.84
3174599-17459998.67298.67
4180589-180589102.057102.06
5171206-17120696.75596.75
6172059-17205997.23797.24
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