缬沙坦胶囊项目信息
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100651-202307对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.1对照品水分(%)0对照品稀释倍数200
标示量(mg)80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%
115.564565414456430045618544563313456292745635620.03
215.624576223457637545762990.01
单位质量响应值RSD%判断
293288.05292976.890.08数据可信
供试品溶液-X3412批-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%
5min1541038-54103810.2899.3331.6510.299.3331.67
2432075-4320758.2178.22
3375711-3757117.1457.14
4784920-78492014.92614.93
5395796-3957967.5277.53
6414601-4146017.8847.88
10min11590713-159071330.25027.5324.8430.2727.5524.85
21437562-143756227.33827.35
3930012-93001217.68617.70
42027212-202721238.55138.58
51312066-131206624.95124.96
61388415-138841526.40326.42
15min12423231-242323146.08242.5020.7246.1542.5620.73
22348930-234893044.66944.73
31444666-144466627.47327.51
42850090-285009054.19954.29
52093398-209339839.80939.86
62248243-224824342.75442.81
20min13094808-309480858.85355.5113.2759.0055.6413.29
23031415-303141557.64757.78
32273304-227330443.23043.32
43429084-342908465.20965.39
52748873-274887352.27452.39
62936549-293654955.84355.97
30min13892049-389204974.01371.926.6474.2672.156.68
23876533-387653373.71873.95
33375126-337512664.18364.34
44102604-410260478.01778.31
53625953-362595368.95369.16
63821190-382119072.66672.89
45min14415244-441524483.96383.113.0284.3383.463.06
24451443-445144384.65185.00
34165593-416559379.21579.48
44510232-451023285.76986.19
54254000-425400080.89781.22
64426592-442659284.17984.52
60min14637416-463741688.18887.901.7388.6988.381.76
24694813-469481389.27989.77
34531797-453179786.17986.58
44674260-467426088.88889.45
54514247-451424785.84686.30
64682178-468217889.03989.52
90min14773252-477325290.77191.251.3491.4291.881.33
24862638-486263892.47193.11
34817554-481755491.61392.16
44778151-477815190.86491.57
54695428-469542889.29189.89
64864266-486426692.50293.13
120min14818705-481870591.63592.331.4992.4493.111.47
24936523-493652393.87694.67
34903091-490309193.24093.93
44810920-481092091.48792.35
54751561-475156190.35891.11
64910606-491060693.38394.17
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限14938138-493813893.90694.771.0494.8695.711.01
25003538-500353895.15096.10
35072614-507261496.46497.31
44976659-497665994.63995.65
54929528-492952893.74394.64
64981838-498183894.73895.68
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