富马酸比索洛尔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10071-202203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)5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%
110.098272582917826438266882655827220.14
210.128274182581826610.14
单位质量响应值RSD%判断
8198.418168.080.27数据可信
中间条件18月-供试品溶液-2022110111批-比索洛尔-0.005Hcl
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min173350-7335080.51087.844.6280.5187.844.62
283519-8351991.67191.67
379606-7960687.37687.38
480136-8013687.95887.96
583374-8337491.51291.51
680196-8019688.02488.02
10min185560-8556093.91297.041.8194.0597.191.81
290045-9004598.83498.99
388798-8879897.46697.61
489702-8970298.45898.60
588109-8810996.70996.86
688269-8826996.88597.03
15min187333-8733395.85898.181.4296.1598.491.42
290581-9058199.42399.74
389612-8961298.35998.67
490779-9077999.64099.95
588815-8881597.48497.80
689567-8956798.31098.62
20min187492-8749296.03297.102.2596.4897.582.24
289658-8965898.41098.89
390116-9011698.91299.38
484885-8488593.17193.65
588889-8888997.56698.04
689773-8977398.53699.01
30min187373-8737395.90298.181.3796.5198.811.37
290069-9006998.86199.51
389831-8983198.60099.24
490743-9074399.601100.23
588654-8865497.30897.95
690009-9000998.79599.43
45min187423-8742395.95797.931.2596.7398.731.25
289715-8971598.47299.28
389524-8952498.26399.06
490493-9049399.326100.12
588397-8839797.02697.83
689795-8979598.56099.36
极限186896-8689695.37897.651.3996.3198.611.39
289574-8957498.31799.29
389216-8921697.92598.89
490353-9035399.173100.14
588180-8818096.78797.75
689552-8955298.29399.26
富马酸比索洛尔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%
113.941038601035831037871037061033281036530.21
213.961030191029121029660.08
单位质量响应值RSD%判断
7435.657375.790.58数据可信
中间条件18月-供试品溶液-2022110111批-氨氯地平-0.005Hcl
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min179442-7944269.54974.176.0269.5574.176.03
291546-9154680.14680.15
384041-8404173.57673.58
482438-8243872.17272.17
590372-9037279.11879.12
680480-8048070.45870.46
10min193101-9310181.50884.434.3381.6284.564.33
2103625-10362590.72190.85
395137-9513783.29083.41
494191-9419182.46282.58
599256-9925686.89687.03
693354-9335481.72981.85
15min198962-9896286.63989.173.6086.8989.443.60
2108235-10823594.75795.04
3101232-10123288.62688.89
499358-9935886.98587.24
5104022-10402291.06991.35
699310-9931086.94387.20
20min1103279-10327990.41891.534.2390.8191.944.22
2110119-11011996.40696.85
3106231-10623193.00293.41
496972-9697284.89685.30
5106604-10660493.32993.76
6104066-10406691.10791.51
30min1108379-10837994.88396.242.0595.4396.802.06
2113807-11380799.635100.24
3111533-11153397.64498.21
4108513-10851395.00095.54
5108496-10849694.98595.57
6108830-10883095.27895.83
45min1112913-11291398.85298.371.3999.5699.101.38
2113713-11371399.553100.32
3113764-11376499.597100.32
4112395-11239598.39999.10
5109592-10959295.94596.69
6111798-11179897.87698.59
极限1112827-11282798.77798.441.3699.6599.341.35
2113721-11372199.560100.50
3113512-11351299.377100.27
4112488-11248898.48099.35
5109490-10949095.85696.76
6112632-11263298.60699.48
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