厄贝沙坦左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100546-202105对照品来源中检院对照品使用方法左氨氯地平需分装，厄贝沙坦105℃烘干2小时
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数8000
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%
113.843170931776318663182531883318120.23
214.013180431649317260.35
单位质量响应值RSD%判断
2298.552264.531.06数据可信
供试品溶液-2024042411批-左氨氯地平-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min124868-2486868.82267.393.8268.8267.393.81
224577-2457768.01768.02
323653-2365365.46065.46
424144-2414466.81866.82
523123-2312363.99363.99
625747-2574771.25571.25
10min132671-3267190.41790.681.6290.8091.051.61
232464-3246489.84490.22
333431-3343192.52092.88
431931-3193188.36988.74
533004-3300491.33891.69
633094-3309491.58791.98
15min134136-3413694.47191.994.9595.3692.874.92
233358-3335892.31893.20
333027-3302791.40292.28
430328-3032883.93384.79
533307-3330792.17793.04
635276-3527697.62698.53
20min134272-3427294.84892.883.0196.2694.262.97
231806-3180688.02389.41
334152-3415294.51595.90
432938-3293891.15692.48
534394-3439495.18596.56
633796-3379693.53094.98
30min133917-3391793.86595.581.7695.8097.491.75
234027-3402794.17096.05
334748-3474896.16598.08
434093-3409394.35296.19
535329-3532997.77399.68
635110-3511097.16799.13
45min135104-3510497.15093.562.9299.6195.992.85
234395-3439595.18897.59
333080-3308091.54993.99
432855-3285590.92693.29
534529-3452995.55998.01
632870-3287090.96893.47
60min133965-3396593.99893.953.2297.0096.913.15
234423-3442395.26598.20
332533-3253390.03592.99
432931-3293191.13694.00
534295-3429594.91197.89
635549-3554998.382101.39
90min134254-3425494.79894.292.7998.3297.772.75
233818-3381893.59197.05
334097-3409794.36397.82
432439-3243989.77593.15
534495-3449595.46598.97
635321-3532197.751101.31
120min133986-3398694.05692.612.5798.1096.612.53
232786-3278690.73594.72
334113-3411394.40898.39
432210-3221089.14193.01
533266-3326692.06396.10
634418-3441895.25299.35
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133434-3343492.52892.192.6497.1096.712.60
232541-3254190.05794.54
333920-3392093.87398.38
432092-3209288.81493.18
533403-3340392.44396.99
634483-3448395.431100.06
厄贝沙坦左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100607-202305对照品来源中检院对照品使用方法105℃烘干2小时
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数200
标示量(mg)150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%
114.982049852204895120479992048226204690420483860.06
215.102045334205011220477230.17
单位质量响应值RSD%判断
136741.39135610.790.59数据可信
供试品溶液-2024042411批-厄贝沙坦-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1628495-62849527.69226.164.8427.6926.164.84
2615247-61524727.10927.11
3563210-56321024.81624.82
4609348-60934826.84926.85
5558640-55864024.61424.61
6586833-58683325.85725.86
10min11217937-121793753.66452.051.9453.8252.201.94
21161977-116197751.19851.35
31192382-119238252.53852.68
41189515-118951552.41252.56
51158029-115802951.02451.16
61168524-116852451.48751.63
15min11446322-144632263.72762.663.5764.1863.103.55
21434727-143472763.21663.65
31426794-142679462.86663.30
41330712-133071258.63359.07
51412122-141212262.22062.64
61482553-148255365.32365.75
20min11617994-161799471.29170.343.0872.1071.123.04
21507401-150740166.41867.20
31640384-164038472.27873.06
41629753-162975371.80972.58
51607504-160750470.82971.59
61575035-157503569.39870.19
30min11828843-182884380.58181.561.5681.7882.731.53
21876573-187657382.68483.84
31827304-182730480.51381.69
41896048-189604883.54284.71
51831280-183128080.68981.85
61845981-184598181.33682.51
45min11997337-199733788.00587.261.8289.6688.881.79
21979993-197999387.24188.86
31913064-191306484.29285.92
41998058-199805888.03789.67
51976666-197666687.09588.70
62017052-201705288.87490.50
60min12050479-205047990.34790.092.8892.4992.202.83
22045741-204574190.13892.24
31935943-193594385.30087.40
42100699-210069992.56094.68
52042311-204231189.98792.08
62092831-209283192.21394.34
90min12080252-208025291.65992.331.0894.3094.941.07
22068247-206824791.13093.73
32090563-209056392.11394.68
42125142-212514293.63796.27
52087989-208798992.00094.59
62120362-212036293.42696.06
120min12078281-207828191.57291.950.9494.7295.070.93
22070331-207033191.22294.33
32098328-209832892.45595.54
42109374-210937492.94296.09
52061247-206124790.82193.92
62103474-210347492.68295.84
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12067365-206736591.09191.811.8894.7595.441.82
22028839-202883989.39393.01
32096526-209652692.37695.97
42128218-212821893.77297.44
52058084-205808490.68294.29
62122604-212260493.52597.19
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