厄贝沙坦非奈利酮片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号D231201对照品来源自制对照品使用方法直接使用
对照品含量(%)99.92对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.166522365130652106502865136651450.12
210.116490465077649900.19
单位质量响应值RSD%判断
6411.916428.290.19数据可信
供试品溶液-BJ86589批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min128343-2834339.70131.8814.5439.7031.8814.54
221043-2104329.47629.48
321924-2192430.71030.71
424796-2479634.73234.73
519013-1901326.63226.63
621436-2143630.02630.03
10min157226-5722680.15876.383.9180.6076.733.95
256204-5620478.72779.05
352576-5257673.64573.99
455421-5542177.63078.02
551750-5175072.48872.78
653988-5398875.62375.96
15min165006-6500691.05689.271.3692.3990.481.42
263318-6331888.69189.89
363814-6381489.38690.55
464392-6439290.19691.44
562607-6260787.69588.80
663254-6325488.60289.78
20min166455-6645593.08593.483.3795.4395.673.27
265350-6535091.53893.73
371135-7113599.641101.79
465753-6575392.10294.35
566691-6669193.41695.49
665035-6503591.09693.25
30min167613-6761394.70794.131.0398.0997.361.04
265989-6598992.43395.64
367836-6783695.02098.28
467615-6761594.71097.98
567341-6734194.32697.44
666813-6681393.58796.76
45min166512-6651293.16592.881.1197.6097.161.12
266656-6665693.36797.60
366749-6674993.49797.81
466940-6694093.76598.09
566080-6608092.56096.72
664932-6493290.95295.16
60min165184-6518491.30591.281.2196.7796.591.16
263938-6393889.56094.83
365919-6591992.33597.69
465421-6542191.63797.01
565938-6593892.36197.55
664598-6459890.48495.71
90min165534-6553491.79590.981.0798.2897.301.08
264063-6406389.73596.00
365458-6545891.68998.07
465249-6524991.39697.78
565338-6533891.52197.74
664065-6406589.73895.96
120min163399-6339988.80589.561.4296.3096.901.35
262803-6280387.97095.23
364226-6422689.96397.36
465455-6545591.68599.09
564154-6415489.86297.10
663605-6360589.09396.32
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限163649-6364989.15588.421.3997.6496.761.34
261964-6196486.79595.03
363848-6384889.43497.83
463296-6329688.66097.08
563899-6389989.50597.74
662107-6210786.99595.21
厄贝沙坦非奈利酮片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号D231201对照品来源自制对照品使用方法直接使用
对照品含量(%)99.92对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.161300351299961300961299841301071300440.05
210.111304961304181304570.05
单位质量响应值RSD%判断
12799.6112903.760.58数据可信
供试品溶液-BXK6BP1批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min136776-3677625.73423.897.7025.7323.897.70
229556-2955620.68220.68
335432-3543224.79324.79
432639-3263922.83922.84
534824-3482424.36824.37
635607-3560724.91624.92
10min178997-7899755.27853.166.9055.5653.436.90
270929-7092949.63249.86
381431-8143156.98157.26
470279-7027949.17849.43
572750-7275050.90751.18
681469-8146957.00857.28
15min1104271-10427172.96370.113.7573.8670.973.77
293654-9365465.53466.32
3102714-10271471.87472.78
499108-9910869.35170.15
599533-9953369.64870.48
6101890-10189071.29772.21
20min1113161-11316179.18478.182.5080.9079.812.55
2106329-10632974.40475.91
3112903-11290379.00480.71
4111658-11165878.13379.70
5112021-11202178.38780.00
6114244-11424479.94281.64
30min1124853-12485387.36686.371.1889.9688.871.26
2121077-12107784.72387.06
3123583-12358386.47789.06
4123147-12314786.17288.61
5122846-12284685.96188.44
6125041-12504187.49790.09
45min1127895-12789589.49491.051.4193.0694.511.41
2128382-12838289.83593.11
3131133-13113391.76095.31
4129501-12950190.61894.01
5131193-13119391.80295.24
6132586-13258692.77796.34
60min1131674-13167492.13991.090.7196.6995.570.73
2129656-12965690.72795.00
3128999-12899990.26794.83
4130186-13018691.09795.50
5129908-12990890.90395.36
6130652-13065291.42496.02
90min1131064-13106491.71291.311.5397.2996.801.44
2130054-13005491.00596.29
3129718-12971890.77096.34
4129278-12927890.46295.88
5134207-13420793.91199.38
6128634-12863490.01195.62
120min1130309-13030991.18490.321.5497.7896.821.52
2126413-12641388.45794.75
3131257-13125791.84798.42
4128312-12831289.78696.21
5130779-13077991.51298.02
6127378-12737889.13395.74
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1127595-12759589.28489.071.0796.9096.571.07
2125315-12531587.68994.97
3126578-12657888.57396.17
4127146-12714688.97096.39
5129426-12942690.56698.09
6127647-12764789.32196.92
厄贝沙坦非奈利酮片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号D231201对照品来源自制对照品使用方法直接使用
对照品含量(%)99.92对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.161302851303621303961303411303701303510.04
210.111309691308851309270.05
单位质量响应值RSD%判断
12829.8212950.250.67数据可信
供试品溶液-BXK6BP1批-pH4.5(内含0.2%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min146239-4623932.26032.688.4232.2632.688.43
247817-4781733.36133.36
344698-4469831.18431.18
442228-4222829.46129.46
546153-4615332.20032.20
653917-5391737.61637.62
10min195524-9552466.64470.268.2867.0070.628.28
2104531-10453172.92873.30
3104370-10437072.81673.16
490756-9075663.31863.65
595441-9544166.58666.94
6113579-11357979.24179.66
15min1118434-11843482.62888.324.2783.7389.464.30
2130674-13067491.16792.35
3129675-12967590.47091.63
4121726-12172684.92585.96
5127012-12701288.61389.71
6132025-13202592.11093.41
20min1132002-13200292.09492.912.3794.1195.042.34
2135902-13590294.81597.01
3135034-13503494.20996.37
4129030-12903090.02091.99
5136688-13668895.36397.45
6130392-13039290.97193.29
30min1132639-13263992.53893.081.6895.5896.241.60
2133981-13398193.47596.72
3132252-13225292.26895.48
4132785-13278592.64095.61
5137586-13758695.99099.13
6131226-13122691.55294.89
45min1134743-13474394.00692.902.1198.0797.092.03
2136570-13657095.28199.57
3131909-13190992.02996.26
4130594-13059491.11295.12
5135411-13541194.47298.68
6129704-12970490.49194.84
60min1130087-13008790.75891.172.4195.8796.402.30
2129985-12998590.68796.03
3129674-12967490.47095.73
4129033-12903390.02395.04
5136959-13695995.552100.81
6128352-12835289.54794.90
90min1130221-13022190.85190.202.1396.9796.442.04
2129069-12906990.04896.40
3129287-12928790.20096.46
4126733-12673388.41894.43
5133998-13399893.48699.81
6126436-12643688.21194.56
120min1128367-12836789.55889.162.5596.6996.402.43
2129785-12978590.54797.90
3126569-12656988.30395.57
4125003-12500387.21194.21
5132902-13290292.722100.08
6124150-12415086.61693.95
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1128122-12812289.38788.081.6597.5196.311.59
2125164-12516487.32395.68
3125172-12517287.32995.57
4124279-12427986.70694.67
5129556-12955690.38798.78
6125238-12523887.37595.67
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