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2000
标示量(mg)8供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.457361173334735847347373443734890.16
215.407418673946740660.23
单位质量响应值RSD%判断
4756.574809.480.79数据可信
长期12月-供试品溶液-2023022521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%
5min113652-1365216.02416.2117.3516.0216.2117.36
216895-1689519.83019.83
311271-1127113.22913.23
414692-1469217.24417.24
510823-1082312.70312.70
615548-1554818.24918.25
10min136309-3630942.61744.528.2542.6444.558.26
241813-4181349.07749.11
336068-3606842.33442.36
440647-4064747.70847.74
533594-3359439.43039.45
639175-3917545.98046.01
15min150811-5081159.63861.974.6559.7462.074.65
253722-5372263.05463.17
352003-5200361.03761.13
456040-5604065.77565.88
549541-4954158.14758.23
654670-5467064.16764.27
20min160408-6040870.90273.334.0871.1073.534.09
264833-6483376.09676.32
361454-6145472.13072.32
465424-6542476.78977.01
559088-5908869.35369.54
663635-6363574.69074.90
30min170559-7055982.81684.762.6283.1385.082.63
273129-7312985.83386.18
371746-7174684.21084.52
474741-7474187.72588.07
569721-6972181.83382.13
673393-7339386.14386.48
45min178260-7826091.85592.801.5292.3193.261.53
277864-7786491.39091.88
378512-7851292.15192.61
480098-8009894.01294.50
578674-7867492.34192.78
680961-8096195.02595.51
60min180721-8072194.74495.551.7395.3596.171.72
279613-7961393.44394.09
380558-8055894.55295.16
481842-8184296.05996.71
582106-8210696.36996.96
683601-8360198.12498.76
极限181327-8132795.45596.472.0496.2297.252.02
280419-8041994.38995.19
381040-8104095.11895.88
482157-8215796.42997.24
583228-8322897.68698.44
684959-8495999.718100.52
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2000
标示量(mg)8供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.457371073566736237342773743736140.18
215.407409074259741740.17
单位质量响应值RSD%判断
4764.664816.490.77数据可信
长期12月-供试品溶液-2023022721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%
5min110491-1049112.29417.0332.5512.2917.0432.56
214684-1468417.20817.21
38407-84079.8529.85
421450-2145025.13725.14
517723-1772320.76920.77
614460-1446016.94516.95
10min134324-3432440.22345.6813.7240.2445.7113.74
240424-4042447.37247.40
331271-3127136.64536.66
445723-4572353.58153.62
542737-4273750.08250.12
639429-3942946.20646.23
15min151822-5182260.72864.327.0860.8264.437.10
256836-5683666.60466.71
348748-4874857.12657.20
459262-5926269.44769.58
557125-5712566.94367.06
655550-5555065.09765.20
20min162174-6217472.86075.635.1373.0575.845.15
266731-6673178.20078.42
359046-5904669.19469.37
467876-6787679.54279.79
566067-6606777.42277.65
665339-6533976.56976.78
30min173126-7312685.69487.233.1986.0087.573.21
276455-7645589.59589.94
370267-7026782.34482.63
476242-7624289.34589.72
575628-7562888.62688.98
674923-7492387.80088.14
45min178966-7896692.53893.761.5392.9994.251.56
281329-8132995.30795.80
378203-7820391.64392.07
481019-8101994.94395.47
580564-8056494.41094.92
679992-7999293.74094.23
60min180881-8088194.78295.840.9095.3996.480.92
282786-8278697.01497.67
381517-8151795.52796.11
482453-8245396.62497.31
581821-8182195.88396.55
681226-8122695.18695.83
极限181433-8143395.42996.650.9596.1997.440.98
283172-8317297.46698.29
382124-8212496.23896.98
483588-8358897.95498.80
582135-8213596.25197.07
682382-8238296.54197.34
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2000
标示量(mg)8供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.457368973826735837370473625736850.13
215.407382773952738900.12
单位质量响应值RSD%判断
4769.264798.050.43数据可信
长期12月-供试品溶液-2023022821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%
5min117139-1713920.11318.4212.4920.1118.4212.49
212270-1227014.39914.40
316343-1634319.17919.18
414437-1443716.94216.94
517060-1706020.02120.02
616922-1692219.85919.86
10min141471-4147148.66846.785.1048.7046.805.11
236885-3688543.28643.31
341071-4107148.19848.23
437733-3773344.28144.31
540433-4043347.45047.48
641556-4155648.76848.80
15min156248-5624866.00964.573.0866.1264.683.09
252895-5289562.07462.17
355928-5592865.63465.75
452828-5282861.99662.10
555706-5570665.37365.49
656511-5651166.31866.43
20min165229-6522976.54975.312.7676.7775.532.76
261646-6164672.34472.54
365035-6503576.32176.54
462334-6233473.15173.36
564720-6472075.95176.17
666090-6609077.55977.78
30min174798-7479887.77887.011.9888.1387.351.99
271923-7192384.40484.72
374528-7452887.46187.81
473155-7315585.85086.18
574239-7423987.12287.47
676201-7620189.42589.78
45min180470-8047094.43594.650.4794.9395.130.47
280449-8044994.41094.87
380459-8045994.42294.92
480858-8085894.89095.36
580346-8034694.28994.78
681317-8131795.42995.93
60min182596-8259696.93097.060.5097.5997.700.48
283385-8338597.85598.47
382175-8217596.43697.09
482786-8278697.15397.78
582823-8282397.19697.85
682458-8245896.76897.43
极限183449-8344997.93198.110.8398.7598.920.81
284788-8478899.502100.28
382912-8291297.30098.11
483656-8365698.17498.96
583846-8384698.39699.21
682961-8296197.35898.18
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2000
标示量(mg)8供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.457401174125740567421573829740470.20
215.407525575300752780.05
单位质量响应值RSD%判断
4792.694888.181.40数据可信
长期12月-供试品溶液-GH011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%
5min19413-941310.91811.7112.4110.9211.7112.41
212355-1235514.33014.33
39730-973011.28611.29
410742-1074212.45912.46
59064-906410.51310.51
69282-928210.76610.77
10min132046-3204637.16936.575.5737.1936.595.57
233523-3352338.88238.91
328767-2876733.36633.38
431167-3116736.15036.17
533099-3309938.39138.41
630572-3057235.46035.48
15min150244-5024458.27756.373.9858.3656.453.98
249304-4930457.18657.28
345687-4568752.99153.07
447739-4773955.37155.45
550927-5092759.06959.15
647678-4767855.30155.38
20min162147-6214772.08369.273.5772.2669.453.57
259541-5954169.06069.24
356811-5681165.89466.06
458775-5877568.17268.34
562272-6227272.22872.41
658804-5880468.20568.37
30min173889-7388985.70282.673.0086.0082.963.00
270779-7077982.09582.39
368439-6843979.38179.65
469851-6985181.01881.31
573633-7363385.40585.71
671077-7107782.44082.72
45min179830-7983092.59390.132.2793.0390.562.27
277785-7778590.22190.66
374883-7488386.85587.26
476825-7682589.10789.53
579176-7917691.83492.28
677736-7773690.16490.58
60min182050-8205095.16892.821.9095.7693.401.90
280307-8030793.14693.73
377732-7773290.15990.71
478938-7893891.55892.13
580927-8092793.86594.46
680221-8022193.04693.62
极限184213-8421397.67796.021.3298.4396.761.33
282898-8289896.15196.89
381214-8121494.19894.90
481904-8190494.99895.72
583579-8357996.94197.69
682920-8292096.17796.90
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