阿齐沙坦氨氯地平片项目信息
介质体积(ml) 900 取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.70对照品水分(%)0对照品稀释倍数1000
标示量(mg)20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%
111.232883642879712881902879462879092880760.07
211.382872102870802871450.04
单位质量响应值RSD%判断
25652.3625232.431.17数据可信
供试品溶液-6060601批-阿齐沙坦-pH5.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min125895-258959.13310.5417.139.1310.5417.15
228853-2885310.17710.18
333512-3351211.82011.82
430892-3089210.89610.90
537160-3716013.10613.11
623033-230338.1248.12
10min188333-8833331.15531.453.7431.2131.513.76
292460-9246032.61132.67
392939-9293932.78032.85
487271-8727130.78130.84
589881-8988131.70131.77
684104-8410429.66429.71
15min1120720-12072042.57842.732.9442.8042.962.95
2125614-12561444.30444.54
3125260-12526044.18044.43
4119836-11983642.26742.50
5118464-11846441.78342.03
6116969-11696941.25541.47
20min1141841-14184150.02849.762.8150.4950.232.80
2145760-14576051.41051.89
3145467-14546751.30751.80
4139253-13925349.11549.58
5136256-13625648.05848.54
6137964-13796448.66049.10
30min1167039-16703958.91558.682.4359.6559.432.43
2170529-17052960.14660.92
3170646-17064660.18760.97
4166073-16607358.57459.31
5160135-16013556.48057.23
6163855-16385557.79258.50
45min1186490-18649065.77665.542.2266.8466.612.21
2188243-18824366.39467.50
3190938-19093867.34468.46
4186429-18642965.75466.82
5178919-17891963.10564.17
6183865-18386564.85065.88
60min1198822-19882270.12569.582.1471.5671.012.13
2200143-20014370.59172.06
3201658-20165871.12572.61
4197198-19719869.55270.98
5189709-18970966.91168.32
6196096-19609669.16470.55
极限1215968-21596876.17375.662.0077.9977.482.00
2218950-21895077.22479.09
3218243-21824376.97578.86
4214808-21480875.76377.58
5207763-20776373.27975.06
6211316-21131674.53276.31
阿齐沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml) 5补液体积(ml)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(%) 99.90对照品水分(%)0对照品稀释倍数4000
标示量(mg)5供试品稀释倍数2系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.796940069339694046933069182693310.13
214.756867968626686520.06
单位质量响应值RSD%判断
4687.694654.370.51数据可信
供试品溶液-6060601批-氨氯地平-pH5.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min143010-4301059.69959.6424.7159.7059.6424.71
252478-5247872.84172.84
334814-3481448.32348.32
426145-2614536.29036.29
549113-4911368.17068.17
652225-5222572.48972.49
10min163707-6370788.42787.585.8688.7687.925.92
268616-6861695.24095.65
359025-5902581.92882.20
459222-5922282.20182.40
562566-6256686.84387.22
665459-6545990.85891.26
15min169020-6902095.80194.671.6596.6295.491.69
269289-6928996.17597.11
367828-6782894.14794.87
467432-6743293.59794.26
566526-6652692.33993.20
669133-6913395.95896.87
20min171157-7115798.76795.413.77100.1296.763.80
269815-6981596.90598.37
369135-6913595.96197.21
463736-6373688.46789.65
568707-6870795.36796.74
669887-6988797.00598.45
30min168412-6841294.95797.462.0496.8699.342.02
272676-72676100.876102.88
369969-6996997.11898.90
470754-7075498.20899.88
570000-7000097.16199.07
669501-6950196.46998.45
45min168940-6894095.69097.051.6998.1299.461.58
270350-7035097.647100.21
371364-7136499.055101.37
471077-7107798.656100.87
568541-6854195.13697.58
669251-6925196.12298.64
60min170562-7056297.94298.121.38100.90101.071.32
271791-7179199.647102.76
371148-7114898.755101.62
471519-7151999.270102.03
569777-6977796.85299.82
669353-6935396.26399.31
极限171946-7194699.86397.942.77103.37101.442.64
271840-7184099.715103.38
371745-7174599.584103.00
471709-7170999.534102.85
567795-6779594.10197.61
668315-6831594.82398.41
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