氢溴酸伏硫西汀片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号D382/2305001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(%)99.83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%
114.321801601802671802371800571801081801660.05
214.401803341805081804210.07
单位质量响应值RSD%判断
12581.4212529.240.30数据可信
供试品溶液-2024051221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%
2min1106390-10639059.89561.546.0059.8961.546.00
2114656-11465664.54864.55
397559-9755954.92354.92
4111945-11194563.02263.02
5110455-11045562.18362.18
6114873-11487364.67064.67
5min1169475-16947595.41094.871.6095.4194.871.60
2164529-16452992.62592.63
3167075-16707594.05894.06
4172320-17232097.01197.01
5167695-16769594.40894.41
6169975-16997595.69195.69
10min1178710-178710100.60999.471.52100.6199.471.52
2171869-17186996.75796.76
3176868-17686899.57299.57
4179600-179600101.110101.11
5176815-17681599.54299.54
6176296-17629699.25099.25
15min1178785-178785100.65199.691.43100.6599.691.43
2172351-17235197.02997.03
3177677-177677100.027100.03
4179423-179423101.010101.01
5177798-177798100.095100.10
6176444-17644499.33399.33
20min1178735-178735100.62399.571.58100.6299.571.58
2171822-17182296.73196.73
3177011-17701199.65299.65
4179864-179864101.258101.26
5177572-17757299.96899.97
6176159-17615999.17399.17
30min1178642-178642100.57099.511.52100.5799.511.52
2171823-17182396.73196.73
3176627-17662799.43699.44
4179520-179520101.065101.06
5177362-17736299.85099.85
6176553-17655399.39499.39
45min1177962-177962100.18899.271.52100.1999.271.52
2171981-17198196.82096.82
3176922-17692299.60299.60
4179781-179781101.212101.21
5174952-17495298.49398.49
6176423-17642399.32199.32
60min1178105-178105100.26899.511.59100.2799.511.59
2172167-17216796.92596.93
3176943-17694399.61499.61
4180753-180753101.759101.76
5176350-17635099.28099.28
6176199-17619999.19599.20
极限1178581-178581100.53699.541.53100.5499.541.53
2171767-17176796.70096.70
3177140-17714099.72599.72
4179413-179413101.004101.00
5177682-177682100.030100.03
6176307-17630799.25699.26
氢溴酸伏硫西汀片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号D382/2305001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(%)99.83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%
114.321835721808531808821806961805211813050.71
214.401799731801711800720.08
单位质量响应值RSD%判断
12660.9612505.000.88数据可信
供试品溶液-2024051221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%
2min1100240-10024056.31059.446.3756.3159.446.38
2103961-10396158.40058.40
3105692-10569259.37359.37
4113118-11311863.54463.54
597576-9757654.81454.81
6114263-11426364.18864.19
5min1159459-15945989.57788.911.8189.5888.911.81
2157524-15752488.49088.49
3160425-16042590.11990.12
4153270-15327086.10086.10
5157660-15766088.56688.57
6161245-16124590.58090.58
10min1167677-16767794.19394.062.2094.1994.062.19
2168007-16800794.37994.38
3168978-16897894.92494.92
4160244-16024490.01890.02
5169245-16924595.07495.07
6170519-17051995.79095.79
15min1169251-16925195.07793.544.1995.0893.544.19
2172067-17206796.65996.66
3170448-17044895.75095.75
4158629-15862989.11089.11
5156667-15666788.00888.01
6172031-17203196.63996.64
20min1169041-16904194.95992.913.4794.9692.923.47
2167935-16793594.33894.34
3161131-16113190.51690.52
4156905-15690588.14288.14
5164645-16464592.49092.49
6172748-17274897.04297.04
30min1170309-17030995.67293.932.8695.6793.922.85
2166780-16678093.68993.69
3167128-16712893.88593.88
4159214-15921489.43989.44
5166314-16631493.42793.43
6173455-17345597.43997.44
45min1170108-17010895.55994.522.7095.5694.522.70
2169050-16905094.96494.96
3167966-16796694.35694.36
4159732-15973289.73089.73
5169537-16953795.23895.24
6173194-17319497.29297.29
60min1170612-17061295.84294.632.7695.8494.632.76
2167026-16702693.82793.83
3168437-16843794.62094.62
4160156-16015689.96889.97
5170981-17098196.04996.05
6173550-17355097.49297.49
极限1171323-17132396.24196.851.6596.2496.851.65
2172400-17240096.84696.85
3172335-17233596.81096.81
4167921-16792194.33094.33
5174042-17404297.76997.77
6176422-17642299.10699.11
氢溴酸伏硫西汀片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号D382/2305001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(%)99.83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%
114.321809231807021810731809311807871808830.08
214.401813941811861812900.09
单位质量响应值RSD%判断
12631.4912589.580.24数据可信
供试品溶液-2024051221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%
2min1124989-12498970.05771.025.5970.0671.025.59
2130385-13038573.08273.08
3115093-11509364.51064.51
4131322-13132273.60773.61
5134946-13494675.63875.64
6123513-12351369.23069.23
5min1173648-17364897.33196.850.9897.3396.850.98
2172865-17286596.89296.89
3170665-17066595.65995.66
4175563-17556398.40498.40
5171822-17182296.30796.31
6172215-17221596.52896.53
10min1175281-17528198.24699.341.1498.2599.341.13
2176493-17649398.92598.93
3179057-179057100.363100.36
4180351-180351101.088101.09
5176254-17625498.79198.79
6175935-17593598.61398.61
15min1178435-178435100.01499.320.95100.0199.320.95
2176002-17600298.65098.65
3177070-17707099.24999.25
4179923-179923100.848100.85
5175908-17590898.59798.60
6175821-17582198.54998.55
20min1177739-17773999.62499.540.9499.6299.540.94
2176587-17658798.97898.98
3177851-17785199.68799.69
4180632-180632101.245101.25
5175853-17585398.56798.57
6176882-17688299.14399.14
30min1177196-17719699.31999.500.9099.3299.500.90
2176909-17690999.15999.16
3177842-17784299.68299.68
4180537-180537101.192101.19
5176166-17616698.74298.74
6176419-17641998.88498.88
45min1178194-17819499.87999.012.1999.8899.012.19
2178304-17830499.94099.94
3177635-17763599.56599.57
4180156-180156100.979100.98
5169188-16918894.83194.83
6176358-17635898.85098.85
60min1178719-178719100.17399.520.84100.1799.520.84
2176759-17675999.07499.07
3176877-17687799.14199.14
4180028-180028100.907100.91
5176300-17630098.81798.82
6176674-17667499.02799.03
极限1179509-179509100.61699.680.93100.6299.680.93
2177074-17707499.25199.25
3176871-17687199.13799.14
4180333-180333101.078101.08
5176452-17645298.90298.90
6176803-17680399.09999.10
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