非布司他片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号101278-202003对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数250
标示量(mg)40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%
19.753742041374727137474183747844374753437464220.07
29.793737670373885537382620.03
单位质量响应值RSD%判断
384248.41381844.940.45数据可信
供试品溶液-4225B批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min131867-318670.7490.7651.200.750.7651.03
225420-254200.5970.60
334886-348860.8200.82
435494-354940.8340.83
557961-579611.3621.36
67193-71930.1690.17
10min149354-493541.1601.0219.641.161.0219.81
245367-453671.0661.07
338246-382460.8990.90
446157-461571.0851.09
552723-527231.2391.24
629101-291010.6840.68
15min151521-515211.2111.0512.241.211.0512.17
242379-423790.9961.00
340461-404610.9510.95
446704-467041.0971.10
549228-492281.1571.16
637346-373460.8770.88
20min141099-410990.9661.044.430.971.044.39
243214-432141.0151.02
343656-436561.0261.03
446119-461191.0841.09
543870-438701.0311.04
646313-463131.0881.09
30min149904-499041.1731.1011.601.181.1111.37
242332-423320.9951.00
356356-563561.3241.33
444584-445841.0481.06
543243-432431.0161.03
643873-438731.0311.04
45min141949-419490.9861.039.381.001.049.07
251569-515691.2121.22
340604-406040.9540.97
445112-451121.0601.07
543307-433071.0181.03
640855-408550.9600.97
60min143169-431691.0141.0210.041.031.039.83
251541-515411.2111.22
339991-399910.9400.95
443701-437011.0271.04
540846-408460.9600.97
640247-402470.9460.96
极限142959-429591.0091.0410.681.031.0510.52
241973-419730.9861.00
353042-530421.2461.26
443994-439941.0341.05
543783-437831.0291.05
639091-390910.9180.93
非布司他片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号101278-202003对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数250
标示量(mg)40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%
19.753736606374903437536313749281374942237475950.18
29.793749300374663137479660.06
单位质量响应值RSD%判断
384368.72382836.160.29数据可信
供试品溶液-4225B批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min118731-187310.4390.4416.620.440.4416.95
213847-138470.3250.32
322075-220750.5180.52
420063-200630.4710.47
521271-212710.4990.50
616443-164430.3860.39
10min135690-356900.8370.8917.220.840.8917.07
230959-309590.7260.73
335384-353840.8300.83
435499-354990.8330.83
539304-393040.9220.92
649908-499081.1711.17
15min138562-385620.9050.864.500.910.874.54
235852-358520.8410.84
336040-360400.8460.85
434459-344590.8080.81
537933-379330.8900.89
638313-383130.8990.90
20min138781-387810.9100.934.650.910.944.62
238077-380770.8930.90
339739-397390.9320.94
438961-389610.9140.92
543286-432861.0161.02
640111-401110.9410.95
30min140641-406410.9540.966.130.960.976.18
241943-419430.9840.99
339012-390120.9150.92
438213-382130.8970.90
541187-411870.9660.97
645347-453471.0641.07
45min140166-401660.9421.0022.050.951.0122.02
237560-375600.8810.89
361272-612721.4381.45
434749-347490.8150.82
541280-412800.9690.98
641706-417060.9790.99
60min140107-401070.9410.921.790.950.931.77
237983-379830.8910.90
339294-392940.9220.93
438864-388640.9120.92
539324-393240.9230.93
639035-390350.9160.93
极限139943-399430.9370.9515.200.950.9614.86
252096-520961.2221.23
335625-356250.8360.85
434944-349440.8200.83
540080-400800.9400.95
640264-402640.9450.96
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