坎地沙坦酯氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.746587565670654966562165539656400.23
213.786596265851659060.12
单位质量响应值RSD%判断
4777.294782.730.09数据可信
长期12月-供试品溶液-2023022521批-pH4.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min156240-5624076.28266.329.6976.2866.329.68
252355-5235571.01271.01
347020-4702063.77663.78
446860-4686063.55963.56
542730-4273057.95757.96
648185-4818565.35665.36
10min170193-7019395.20795.533.2595.3395.643.25
274431-74431100.955101.07
369068-6906893.68193.79
471560-7156097.06197.17
568048-6804892.29892.39
669297-6929793.99294.10
15min171882-7188297.49896.342.3697.7896.612.37
272679-7267998.57998.87
369673-6967394.50294.76
472070-7207097.75398.02
568314-6831492.65892.91
671568-7156897.07297.34
20min171515-7151597.00096.882.5897.4597.312.58
273354-7335499.49499.95
369199-6919993.85994.28
473718-7371899.988100.42
569761-6976194.62195.03
671000-7100096.30296.73
30min173243-7324399.34497.421.9499.9598.011.94
273566-7356699.782100.40
370230-7023095.25795.83
471596-7159697.11097.71
571889-7188997.50798.07
670413-7041395.50596.09
45min174315-74315100.79896.642.70101.5797.402.69
270470-7047095.58396.37
369247-6924793.92494.66
472567-7256798.42799.19
571283-7128396.68597.41
669624-6962494.43595.18
60min174101-74101100.50897.132.84101.4598.042.83
271596-7159697.11098.05
368712-6871293.19894.09
473732-73732100.007100.93
570987-7098796.28497.17
670540-7054095.67896.58
极限170775-7077595.99696.741.7097.1197.811.68
271217-7121796.59697.70
369857-6985794.75195.80
473324-7332499.454100.54
572011-7201197.67398.72
670735-7073595.94297.01
坎地沙坦酯氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.746560365542656756542765488655470.15
213.786567765646656620.04
单位质量响应值RSD%判断
4770.524765.020.09数据可信
长期12月-供试品溶液-2023022721批-pH4.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min150030-5003068.03359.2625.5068.0359.2625.51
236079-3607949.06249.06
343318-4331858.90658.91
461136-6113683.13583.14
529168-2916839.66439.66
641721-4172156.73456.73
10min170389-7038995.71892.353.0495.8392.453.05
267158-6715891.32491.41
370127-7012795.36295.46
468333-6833392.92293.06
565909-6590989.62689.69
665570-6557089.16589.26
15min172926-7292699.16896.932.5099.4497.182.49
271994-7199497.90098.13
372992-7299299.25899.51
469269-6926994.19594.49
571566-7156697.31897.53
668917-6891793.71693.96
20min174248-74248100.96597.782.07101.4098.202.06
271839-7183997.69098.09
372415-7241598.47398.90
469958-6995895.13295.58
572222-7222298.21098.59
670750-7075096.20996.61
30min172137-7213798.09596.763.8398.7097.343.79
272852-7285299.06799.63
372870-7287099.09299.68
466088-6608889.86990.48
572960-7296099.21499.76
670012-7001295.20595.76
45min172954-7295499.20696.741.8699.9897.481.85
270313-7031395.61496.34
370836-7083696.32697.08
469367-6936794.32895.09
572366-7236698.40699.11
670996-7099696.54397.26
60min173913-73913100.51097.742.30101.4598.642.28
272577-7257798.69399.58
372236-7223698.22999.14
469065-6906593.91794.83
572392-7239298.44299.31
671060-7106096.63097.51
极限173730-73730100.26196.642.79101.3697.702.76
270889-7088996.39897.45
371111-7111196.70097.78
467805-6780592.20493.28
572295-7229598.31099.34
670554-7055495.94296.98
坎地沙坦酯氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.746563865660656016561165488656000.11
213.786655166705666280.17
单位质量响应值RSD%判断
4774.384835.120.90数据可信
长期12月-供试品溶液-2023022821批-pH4.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min138798-3879852.35567.5614.8352.3667.5614.83
250544-5054468.20668.21
356618-5661876.40276.40
457234-5723477.23377.23
543610-4361058.84958.85
653569-5356972.28872.29
10min167255-6725590.75691.542.9190.8491.652.92
268377-6837792.27092.38
368088-6808891.88092.01
470187-7018794.71294.84
564322-6432286.79886.90
668768-6876892.79792.92
15min170563-7056395.22094.261.8995.4694.521.90
269658-6965893.99894.27
370933-7093395.71996.00
470884-7088495.65395.94
567434-6743490.99791.24
669628-6962893.95894.23
20min171709-7170996.76696.201.5397.1696.621.52
272559-7255997.91398.34
370347-7034794.92895.37
472158-7215897.37297.82
571258-7125896.15896.55
669713-6971394.07394.50
30min171491-7149196.47295.082.4997.0395.672.47
273246-7324698.84099.43
368845-6884592.90193.50
470583-7058395.24795.85
570072-7007294.55795.11
668539-6853992.48893.08
45min172875-7287598.34096.232.2099.0696.972.19
273040-7304098.56299.31
370460-7046095.08195.83
472119-7211997.31998.09
569397-6939793.64694.36
669981-6998194.43495.18
60min171601-7160196.62095.221.9197.5096.121.90
272578-7257897.93998.86
369877-6987794.29495.21
470771-7077195.50096.43
569099-6909993.24494.11
669451-6945193.71994.62
极限171250-7125096.14795.092.8297.1996.152.79
273764-7376499.539100.62
367812-6781291.50792.58
470131-7013194.63795.73
569482-6948293.76194.78
670373-7037394.96396.02
坎地沙坦酯氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.746528165304652596542265396653320.12
213.786587966037659580.17
单位质量响应值RSD%判断
4754.884786.500.47数据可信
长期12月-供试品溶液-GH011批-pH4.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min129731-2973140.40538.938.7340.4138.938.74
225483-2548334.63234.63
326309-2630935.75535.75
432272-3227243.85843.86
528280-2828038.43338.43
629789-2978940.48440.48
10min166270-6627090.06386.933.3090.1387.003.30
260715-6071582.51382.57
362214-6221484.55084.61
464134-6413487.16087.23
565356-6535688.82088.88
665119-6511988.49888.57
15min170409-7040995.68893.582.2295.9093.792.22
266490-6649090.36290.56
369334-6933494.22794.43
468205-6820592.69292.91
570470-7047095.77095.98
668243-6824392.74492.96
20min170916-7091696.37795.421.5196.7595.781.51
268994-6899493.76594.11
370889-7088996.34096.70
469274-6927494.14594.52
569600-6960094.58894.96
671586-7158697.28797.66
30min172564-7256498.61695.662.1999.1596.182.19
269779-6977994.83195.33
367992-6799292.40392.92
469977-6997795.10095.63
570849-7084996.28596.81
671171-7117196.72397.25
45min172507-7250798.53997.441.1199.2498.121.11
271035-7103596.53897.20
372467-7246798.48499.16
470528-7052895.84996.54
571664-7166497.39398.08
671971-7197197.81098.50
60min171567-7156797.26195.321.7298.1396.171.72
269306-6930694.18995.01
368938-6893893.68894.52
471708-7170897.45398.30
569924-6992495.02895.88
669396-6939694.31195.17
极限172210-7221098.13597.181.9499.1698.181.92
272892-7289299.062100.04
372878-7287899.043100.04
469476-6947694.42095.43
571067-7106796.58297.59
670502-7050295.81496.83
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