氢溴酸伏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%
113.781752671751711760091757341752631754890.21
213.831734831737551736190.12
单位质量响应值RSD%判断
12735.0512553.801.02数据可信
中间条件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%
2min1118734-11873466.42362.213.7466.4262.203.74
2106922-10692259.81559.81
3109637-10963761.33361.33
4108459-10845960.67460.67
5111091-11109162.14762.15
6112331-11233162.84162.84
5min1173290-17329096.94295.542.2096.9495.542.20
2164903-16490392.25192.25
3170760-17076095.52795.53
4174886-17488697.83597.84
5172897-17289796.72396.72
6167982-16798293.97393.97
10min1177242-17724299.15397.811.6799.1597.811.67
2171581-17158195.98695.99
3174430-17443097.58097.58
4178848-178848100.052100.05
5175233-17523398.02998.03
6171743-17174396.07796.08
15min1179743-179743100.55299.042.37100.5599.042.37
2171789-17178996.10396.10
3173738-17373897.19397.19
4179582-179582100.462100.46
5182555-182555102.125102.13
6174867-17486797.82597.82
20min1177835-17783599.48598.442.0699.4998.452.06
2171495-17149595.93895.94
3174806-17480697.79197.79
4181913-181913101.766101.77
5176093-17609398.51098.51
6173712-17371297.17997.18
30min1176902-17690298.96397.291.3498.9697.281.34
2170653-17065395.46795.47
3174277-17427797.49597.49
4176009-17600998.46498.46
5172454-17245496.47596.47
6173132-17313296.85496.85
45min1176979-17697999.00698.522.6999.0198.522.69
2170666-17066695.47595.47
3178409-17840999.80699.81
4176766-17676698.88798.89
5170799-17079995.54995.55
6182992-182992102.370102.37
60min1176781-17678198.89597.541.4998.9097.541.49
2170393-17039395.32295.32
3172963-17296396.76096.76
4177373-17737399.22799.23
5174920-17492097.85497.85
6173732-17373297.19097.19
极限1171766-17176696.09098.931.9396.0998.931.93
2181652-181652101.620101.62
3174295-17429597.50597.50
4177953-17795399.55199.55
5177580-17758099.34299.34
6177824-17782499.47999.48
氢溴酸伏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%
113.781748151758631759601765411762801758920.38
213.831741961755411748680.55
单位质量响应值RSD%判断
12764.3012644.110.67数据可信
中间条件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%
2min1120480-12048067.08066.361.6367.0866.361.63
2117641-11764165.50065.50
3119804-11980466.70466.70
4120972-12097267.35467.35
5116009-11600964.59164.59
6120169-12016966.90766.91
5min1167730-16773093.38893.581.3093.3993.581.30
2166662-16666292.79392.79
3168525-16852593.83093.83
4172228-17222895.89295.89
5166823-16682392.88392.88
6166493-16649392.69992.70
10min1173657-17365796.68899.753.6696.6999.753.66
2184619-184619102.791102.79
3172757-17275796.18796.19
4178744-17874499.52099.52
5189285-189285105.389105.39
6175833-17583397.89997.90
15min1174060-17406096.91297.710.9196.9197.710.91
2175106-17510697.49597.49
3173643-17364396.68096.68
4177960-17796099.08499.08
5175678-17567897.81397.81
6176493-17649398.26798.27
20min1177194-17719498.65798.500.9698.6698.500.96
2180193-180193100.327100.33
3176006-17600697.99698.00
4175817-17581797.89097.89
5176413-17641398.22298.22
6175896-17589697.93497.93
30min1174437-17443797.12297.771.6397.1297.771.64
2175673-17567397.81097.81
3171749-17174995.62595.63
4180513-180513100.505100.51
5175043-17504397.46097.46
6176160-17616098.08198.08
45min1176078-17607898.03699.391.9698.0499.391.96
2179142-17914299.74299.74
3175770-17577097.86497.86
4179469-17946999.92499.92
5184738-184738102.857102.86
6175848-17584897.90897.91
60min1177520-17752098.83997.851.5798.8497.851.57
2173053-17305396.35296.35
3173750-17375096.74096.74
4180426-180426100.457100.46
5174680-17468097.25797.26
6175053-17505397.46597.47
极限1176174-17617498.08997.791.0598.0997.781.05
2173412-17341296.55196.55
3174244-17424497.01597.01
4178735-17873599.51599.52
5175584-17558497.76197.76
6175623-17562397.78297.78
氢溴酸伏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%
113.781754631761701760571761461756241758920.19
213.831770611768501769560.09
单位质量响应值RSD%判断
12764.3012795.080.18数据可信
中间条件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%
2min1117450-11745065.00669.758.8765.0169.758.88
2132756-13275673.47773.48
3119243-11924365.99866.00
4145726-14572680.65680.66
5118242-11824265.44465.44
6122706-12270667.91567.91
5min1168749-16874993.39893.700.6093.4093.700.60
2169502-16950293.81593.82
3168395-16839593.20293.20
4170328-17032894.27294.27
5168237-16823793.11593.11
6170592-17059294.41894.42
10min1174655-17465596.66797.531.3396.6797.531.33
2172729-17272995.60195.60
3179630-17963099.42199.42
4176405-17640597.63697.64
5177016-17701697.97497.97
6176886-17688697.90297.90
15min1174845-17484596.77297.530.5196.7797.530.51
2175682-17568297.23597.24
3176982-17698297.95597.95
4177305-17730598.13498.13
5176315-17631597.58697.59
6176133-17613397.48597.49
20min1175849-17584997.32897.911.0797.3397.911.07
2173640-17364096.10596.11
3177019-17701997.97597.98
4178396-17839698.73898.74
5178336-17833698.70498.70
6178188-17818898.62298.62
30min1175532-17553297.15297.950.7097.1597.940.70
2176937-17693797.93097.93
3176088-17608897.46097.46
4177790-17779098.40298.40
5176512-17651297.69597.69
6178951-17895199.04599.04
45min1175954-17595497.38697.740.3897.3997.740.38
2177086-17708698.01398.01
3176356-17635697.60997.61
4177446-17744698.21298.21
5176924-17692497.92397.92
6175754-17575497.27597.28
60min1176652-17665297.77298.021.6397.7798.021.63
2176655-17665597.77497.77
3181848-181848100.648100.65
4173020-17302095.76295.76
5176313-17631397.58597.58
6178146-17814698.59998.60
极限1173534-17353496.04797.261.0796.0597.261.07
2174419-17441996.53696.54
3174404-17440496.52896.53
4176438-17643897.65497.65
5178014-17801498.52698.53
6177582-17758298.28798.29
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