坎地沙坦酯片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号61123040205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(%)100.5对照品水分(%)0.14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%
116.261957771955911958801956781952521956360.13
216.171973081975781974430.10
单位质量响应值RSD%判断
12031.7312210.451.05数据可信
供试品溶液-1批-pH6.8(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min15541-55412.5813.5221.732.583.5221.71
26120-61202.8502.85
38202-82023.8203.82
410078-100784.6944.69
57175-71753.3423.34
68204-82043.8213.82
10min137134-3713417.29621.1014.4617.3221.1414.47
238550-3855017.95517.99
347940-4794022.32922.37
454172-5417225.23125.28
544755-4475520.84520.88
649320-4932022.97123.01
15min179295-7929536.93243.3111.9337.1543.5811.95
280960-8096037.70837.94
395612-9561244.53244.82
4105950-10595049.34749.68
592732-9273243.19143.46
6103365-10336548.14348.44
20min1117285-11728554.62761.508.1555.2662.258.22
2120651-12065156.19456.84
3136640-13664063.64164.43
4143753-14375366.95467.84
5133407-13340762.13662.88
6140466-14046665.42366.26
30min1164970-16497076.83681.524.0878.0782.954.18
2167099-16709977.82879.10
3176812-17681282.35283.84
4180645-18064584.13785.76
5180254-18025483.95585.39
6180340-18034083.99585.55
45min1190569-19056988.75989.982.0690.8592.332.13
2191625-19162589.25191.39
3188270-18827087.68990.10
4199453-19945392.89795.46
5195656-19565691.12993.50
6193612-19361290.17792.67
60min1198211-19821192.31992.350.7595.4095.700.72
2199263-19926392.80995.94
3196076-19607691.32494.71
4198663-19866392.52996.12
5200254-20025493.27096.65
6197245-19724591.86995.36
极限1200356-20035693.31892.791.1697.4297.161.18
2195914-19591491.24995.41
3199177-19917792.76997.17
4200691-20069193.47498.09
5202026-20202694.09698.52
6197219-19721991.85796.37
坎地沙坦酯片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号61123040205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(%)100.5对照品水分(%)0.14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%
116.261965191963511963741963111960691963250.09
216.171963501960671962080.11
单位质量响应值RSD%判断
12074.1112134.080.36数据可信
供试品溶液-3批-pH6.8(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min125170-2517011.7399.8020.0211.749.8020.05
222356-2235610.42710.43
319370-193709.0349.03
414605-146056.8126.81
518977-189778.8518.85
625656-2565611.96611.97
10min174629-7462934.80630.2116.1934.9430.3216.20
266585-6658531.05531.17
358660-5866027.35927.46
447944-4794422.36122.44
564734-6473430.19130.29
676122-7612235.50335.64
15min1117324-11732454.71949.4012.1055.2449.8412.14
2109994-10999451.30051.76
3100039-10003946.65747.06
482788-8278838.61238.94
5110130-11013051.36451.80
6115235-11523553.74554.27
20min1144518-14451867.40263.717.7968.5364.707.88
2143585-14358566.96768.00
3129822-12982260.54861.47
4117949-11794955.01055.76
5143473-14347366.91567.92
6140279-14027965.42566.55
30min1172842-17284280.61279.811.4582.4981.511.45
2171348-17134879.91581.69
3166457-16645777.63479.23
4173258-17325880.80682.17
5172137-17213780.28382.03
6170719-17071979.62281.47
45min1184227-18422785.92287.130.9388.6989.720.87
2188638-18863887.97990.64
3188856-18885688.08190.54
4186141-18614186.81589.08
5186392-18639286.93289.57
6186706-18670687.07889.81
60min1186982-18698287.20787.941.9190.9391.491.65
2184646-18464686.11789.76
3192276-19227689.67693.11
4193405-19340590.20293.43
5188457-18845787.89591.50
6185503-18550386.51790.22
极限1188186-18818687.76887.321.0992.4691.850.95
2185259-18525986.40391.00
3187830-18783087.60292.04
4189173-18917388.22992.46
5188714-18871488.01592.60
6184156-18415685.88990.55
坎地沙坦酯片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号61123040205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(%)100.5对照品水分(%)0.14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%
116.261962231965181966591958321964121963290.17
216.171971651969921970780.07
单位质量响应值RSD%判断
12074.3512187.880.67数据可信
供试品溶液-24110401批-pH6.8(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min134406-3440616.01115.0911.7016.0115.0911.71
232969-3296915.34215.34
337834-3783417.60617.61
427279-2727912.69512.69
533017-3301715.36515.36
629027-2902713.50813.51
10min187827-8782740.87139.846.9941.0540.017.00
287413-8741340.67840.85
392453-9245343.02443.22
474684-7468434.75534.90
587127-8712740.54540.72
684187-8418739.17739.33
15min1124703-12470358.03257.505.2858.6658.115.30
2125478-12547858.39259.01
3129720-12972060.36661.04
4110788-11078851.55652.08
5125150-12515058.24058.86
6125494-12549458.40058.99
20min1149030-14903069.35368.364.2070.6369.624.23
2147855-14785568.80670.08
3149948-14994869.78071.12
4134477-13447762.58063.68
5149470-14947069.55770.83
6150666-15066670.11471.35
30min1175508-17550881.67479.972.7183.7281.982.77
2173853-17385380.90482.94
3173696-17369680.83182.95
4162694-16269475.71177.51
5173669-17366980.81982.86
6171605-17160579.85881.87
45min1183422-18342285.35786.050.8588.3188.950.86
2186629-18662986.85089.78
3183642-18364285.46088.48
4183626-18362685.45288.09
5185384-18538486.27089.21
6186810-18681086.93489.83
60min1187454-18745487.23487.550.9891.1491.400.85
2187371-18737187.19591.09
3187025-18702587.03491.00
4190439-19043988.62392.21
5186105-18610586.60690.50
6190410-19041088.60992.48
极限1187814-18781487.40187.271.6292.2792.091.42
2186705-18670586.88591.75
3185372-18537286.26591.20
4192817-19281789.72994.30
5184065-18406585.65690.52
6188390-18839087.66992.52
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