坎地沙坦酯左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100685-201903对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数4000
标示量(mg)8供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.251727221720621721641722641717091721840.22
216.261726781731651729220.20
单位质量响应值RSD%判断
10595.9410634.810.26数据可信
供试品溶液-24092401批-pH6.8(内含0.1%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min143959-4395923.24723.003.3223.2523.003.32
240575-4057521.45721.46
343772-4377223.14823.15
444249-4424923.40023.40
544281-4428123.41723.42
644120-4412023.33223.33
10min183231-8323144.01543.720.9844.2743.980.99
281080-8108042.87843.12
382737-8273743.75444.01
482934-8293443.85844.12
583157-8315743.97644.24
682955-8295543.86944.13
15min1107098-10709856.63756.521.3157.3857.261.31
2104853-10485355.45056.16
3107996-10799657.11257.86
4105473-10547355.77856.53
5107616-10761656.91157.66
6108204-10820457.22257.97
20min1124710-12471065.95165.921.5267.3367.291.51
2122124-12212464.58365.91
3126275-12627566.77868.16
4123208-12320865.15766.52
5124404-12440465.78967.17
6127223-12722367.28068.66
30min1145053-14505376.70977.040.8778.8279.150.87
2143839-14383976.06778.12
3146804-14680477.63579.75
4145505-14550576.94879.04
5145572-14557276.98379.10
6147344-14734477.92080.05
45min1161579-16157985.44886.001.5588.4188.961.48
2166856-16685688.23991.13
3163692-16369286.56689.55
4160313-16031384.77987.72
5160184-16018484.71187.68
6163116-16311686.26189.26
60min1169283-16928389.52388.450.7893.4392.360.74
2168196-16819688.94892.82
3167159-16715988.39992.34
4165713-16571387.63591.52
5166305-16630587.94891.86
6166901-16690188.26392.22
极限1170411-17041190.11990.470.5595.0295.360.53
2171605-17160590.75195.61
3172728-17272891.34496.27
4170331-17033190.07794.94
5170631-17063190.23595.12
6170751-17075190.29995.23
坎地沙坦酯左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100685-201903对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数4000
标示量(mg)8供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.251738581729881731841730791731381732490.21
216.261757941763041760490.21
单位质量响应值RSD%判断
10661.4810827.121.10数据可信
供试品溶液-1批-pH6.8(内含0.1%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min134458-3445818.00519.505.0318.0019.505.03
237169-3716919.42119.42
338009-3800919.86019.86
438417-3841720.07420.07
539811-3981120.80220.80
636087-3608718.85618.86
10min167188-6718835.10736.462.2435.3136.682.25
270907-7090737.05037.27
369268-6926836.19436.41
470590-7059036.88537.11
571507-7150737.36437.59
669230-6923036.17436.38
15min188138-8813846.05447.541.8746.6448.161.88
292233-9223348.19348.82
390527-9052747.30247.92
490377-9037747.22447.86
592859-9285948.52049.17
691755-9175547.94448.56
20min1105800-10580055.28255.981.7456.3857.131.72
2107306-10730656.06957.23
3105067-10506754.89956.05
4105961-10596155.36656.52
5109505-10950557.21858.40
6109165-10916557.04158.18
30min1127416-12741666.57767.091.1568.2968.861.15
2128907-12890767.35669.14
3127711-12771166.73168.49
4126372-12637266.03267.80
5129932-12993267.89269.71
6130017-13001767.93669.71
45min1144676-14467675.59676.690.9978.0579.211.00
2146845-14684576.72979.26
3147664-14766477.15779.66
4145344-14534475.94578.45
5148065-14806577.36779.94
6148039-14803977.35379.89
60min1154505-15450580.73282.081.1484.0385.461.14
2158484-15848482.81186.20
3157542-15754282.31885.68
4155301-15530181.14784.50
5157848-15784882.47885.91
6158887-15888783.02186.41
极限1161339-16133984.30285.621.3188.5089.901.29
2164170-16417085.78290.09
3164149-16414985.77190.04
4161625-16162584.45288.70
5164813-16481386.11890.47
6167062-16706287.29391.61
坎地沙坦酯左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100685-201903对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数4000
标示量(mg)8供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.251735731728461726711725751728451729020.23
216.261734631743061738840.35
单位质量响应值RSD%判断
10640.1210693.970.36数据可信
供试品溶液-2批-pH6.8(内含0.1%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min136558-3655819.24020.416.3219.2420.416.32
236049-3604918.97218.97
341035-4103521.59621.60
441394-4139421.78521.78
537132-3713219.54219.54
640496-4049621.31221.31
10min171905-7190537.84237.983.6638.0638.213.66
267131-6713135.32935.54
372612-7261238.21438.45
474656-7465639.28939.53
573488-7348838.67538.89
673249-7324938.54938.79
15min194437-9443749.70049.411.5350.3350.061.55
291552-9155248.18148.78
393927-9392749.43150.10
495378-9537850.19550.87
595075-9507550.03550.68
692932-9293248.90849.57
20min1111149-11114958.49558.581.4559.6859.781.45
2110064-11006457.92459.06
3110093-11009357.93959.15
4112582-11258259.24960.49
5113904-11390459.94561.15
6110087-11008757.93659.14
30min1133389-13338970.19970.310.8772.0472.160.85
2134253-13425370.65472.44
3131409-13140969.15771.01
4134051-13405170.54872.44
5134688-13468870.88372.75
6133833-13383370.43372.29
45min1151912-15191279.94780.221.0882.5682.851.04
2153309-15330980.68283.25
3151498-15149879.72982.36
4151045-15104579.49182.17
5155364-15536481.76484.42
6151455-15145579.70782.34
60min1158265-15826583.29184.670.9286.8088.190.90
2160629-16062984.53588.00
3161494-16149484.99088.50
4160631-16063184.53688.10
5162521-16252185.53189.10
6161746-16174685.12388.64
极限1165864-16586487.29087.910.9191.7292.370.91
2165306-16530686.99691.40
3165908-16590887.31391.77
4168053-16805388.44292.94
5168259-16825988.55093.07
6168859-16885988.86693.33
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