左氨氯地平叶酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100546-202105 对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数5000
标示量(mg)2.5供试品稀释倍数2系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.38 7154771800717377197571926717970.24
216.697198671761718740.23
单位质量响应值RSD%判断
4383.214306.411.25数据可信
供试品溶液-2024092121批-左氨氯地平-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min141449-4144996.38095.572.9496.3895.572.93
240938-4093895.19295.19
343308-43308100.703100.70
440579-4057994.35794.36
540506-4050694.18794.19
639832-3983292.62092.62
10min143575-43575101.32498.744.31102.3999.804.29
242539-4253998.91599.97
345347-45347105.444106.56
442083-4208397.85498.90
540937-4093795.19096.24
640307-4030793.72594.75
15min142705-4270599.30198.412.45101.50100.572.47
242247-4224798.236100.39
344155-44155102.672104.96
441665-4166596.88299.02
541985-4198597.62799.73
641182-4118295.75997.83
20min142874-4287499.69496.603.14102.9999.853.13
240720-4072094.68597.93
343370-43370100.847104.28
441370-4137096.19699.41
540870-4087095.03498.22
640060-4006093.15096.28
30min141961-4196197.57196.112.81101.98100.442.80
240974-4097495.27699.58
342833-4283399.598104.15
440706-4070694.65298.93
541963-4196397.575101.82
639560-3956091.98896.16
45min141877-4187797.37592.603.07102.8798.002.94
240341-4034193.80499.16
338849-3884990.33495.99
439956-3995692.90998.24
539453-3945391.73997.07
638466-3846689.44494.64
60min140863-4086395.01890.804.30101.5997.234.06
240122-4012293.29599.70
338501-3850189.52596.19
439741-3974192.40998.77
536078-3607883.89190.24
638998-3899890.68196.87
90min141230-4123095.87191.503.16103.5098.933.05
238382-3838289.24996.69
340440-4044094.034101.69
438033-3803388.43795.83
539169-3916991.07998.36
638839-3883990.31197.50
极限138190-3819088.80290.293.5997.5098.743.42
238902-3890290.45898.89
341535-4153596.580105.28
438128-3812888.65897.03
538554-3855489.64997.94
637662-3766287.57495.77
左氨氯地平叶酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100074-202217 对照品来源中检院对照品使用方法直接使用
对照品含量(%)91.2对照品水分(%)0对照品稀释倍数20000
标示量(mg)0.8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%
116.219531595215954649551195355953720.13
216.259539195377953840.02
单位质量响应值RSD%判断
5883.535869.780.17数据可信
供试品溶液-2024092121批-叶酸-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min117677-1767730.86229.313.4830.8629.323.48
217152-1715229.94629.95
316849-1684929.41729.42
416513-1651328.83028.83
516570-1657028.92928.93
615982-1598227.90327.90
10min127505-2750548.02146.702.5748.3647.032.57
226769-2676946.73647.07
327126-2712647.35947.69
427088-2708847.29347.61
526470-2647046.21446.54
625545-2554544.59944.91
15min133396-3339658.30656.562.4559.1857.412.45
231770-3177055.46756.32
333005-3300557.62358.48
432424-3242456.60957.45
532556-3255656.83957.67
631238-3123854.53855.34
20min137836-3783666.05863.103.3767.5864.573.34
235727-3572762.37663.84
336093-3609363.01564.51
436419-3641963.58465.06
536628-3662863.94965.42
634136-3413659.59861.01
30min141603-4160372.63470.333.1274.8972.503.10
239955-3995569.75771.92
340062-4006269.94472.14
440832-4083271.28873.47
541175-4117571.88774.06
638072-3807266.47068.54
45min144942-4494278.46477.053.4681.5380.003.41
245491-4549179.42282.36
344216-4421677.19680.17
444867-4486778.33381.31
544060-4406076.92479.90
641208-4120871.94574.76
60min146739-4673981.60180.544.1285.5484.354.04
247219-4721982.43986.26
346099-4609980.48484.31
448228-4822884.20188.04
545847-4584780.04483.87
642665-4266574.48978.10
90min148518-4851884.70783.794.5989.5588.504.47
249800-4980086.94591.68
347130-4713082.28487.01
450681-5068188.48493.26
547344-4734482.65887.38
644488-4448877.67182.11
极限151436-5143689.80289.071.8795.5994.711.93
251107-5110789.22794.93
350886-5088688.84294.48
452323-5232391.35097.11
550942-5094288.93994.58
649398-4939886.24491.55
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