阿齐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直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数6250
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%
112.455134850968510525115451449511940.40
212.435133451515514240.25
单位质量响应值RSD%判断
4111.974137.090.44数据可信
供试品溶液-24051501批-左氨氯地平-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min148365-4836594.76898.702.3994.7798.702.39
249899-4989997.77497.77
351574-51574101.056101.06
450631-5063199.20899.21
551555-51555101.019101.02
650213-5021398.38998.39
10min150974-5097499.880100.851.36100.41101.401.36
250946-5094699.825100.37
352190-52190102.263102.82
451677-51677101.258101.81
552330-52330102.537103.10
650685-5068599.31499.86
15min150366-5036698.68999.302.5999.77100.412.57
250441-5044198.83699.93
351900-51900101.695102.82
451357-51357100.631101.74
551667-51667101.238102.37
648338-4833894.71595.81
20min147187-4718792.46097.693.5594.0999.353.52
248211-4821194.46696.11
351526-51526100.962102.66
450652-5065299.249100.92
551361-51361100.638102.33
650196-5019698.35699.98
30min149401-4940196.79897.692.9398.9499.892.90
247172-4717292.43094.60
351302-51302100.523102.78
450580-5058099.108101.33
550628-5062899.202101.45
650045-5004598.060100.23
45min149065-4906596.14096.531.9198.8299.271.87
249387-4938796.77199.46
350208-5020898.379101.19
447507-4750793.08795.86
549660-4966097.305100.11
649749-4974997.480100.20
60min148906-4890695.82896.981.1599.04100.261.17
249141-4914196.28899.51
350200-5020098.364101.72
449655-4965597.296100.59
550075-5007598.119101.46
648974-4897495.96199.22
极限149059-4905996.12895.893.0799.8899.713.00
246064-4606490.25994.02
350157-5015798.279102.19
449837-4983797.652101.48
549756-4975697.494101.38
648751-4875195.52499.31
阿齐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%
111.053879093879233877783872323877853877250.08
211.153867473869003868240.03
单位质量响应值RSD%判断
35088.2434692.740.81数据可信
供试品溶液-24051501批-阿齐沙坦-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min15375-53751.3821.1912.971.381.1912.97
24558-45581.1721.17
34100-41001.0541.05
43848-38480.9900.99
54694-46941.2071.21
65223-52231.3431.34
10min118371-183714.7254.536.624.734.546.60
217732-177324.5604.57
317417-174174.4794.49
415456-154563.9753.98
518806-188064.8374.84
617899-178994.6034.61
15min126615-266156.8457.019.136.887.049.09
226794-267946.8916.92
326871-268716.9116.94
423953-239536.1606.19
527802-278027.1507.18
631611-316118.1308.16
20min130691-306917.8938.194.797.978.264.79
231814-318148.1828.25
332391-323918.3308.40
429540-295407.5977.66
533649-336498.6548.73
633031-330318.4958.57
30min139880-3988010.25710.334.6810.3710.454.70
239479-3947910.15310.27
340845-4084510.50510.62
436978-369789.5109.61
542261-4226110.86910.99
641599-4159910.69910.82
45min148000-4800012.34512.295.6712.5212.475.65
248983-4898312.59812.77
348613-4861312.50312.68
442387-4238710.90111.06
549503-4950312.73112.91
649332-4933212.68712.87
60min152671-5267113.54613.593.0613.7913.833.08
253889-5388913.85914.10
352848-5284813.59213.83
449762-4976212.79813.02
554091-5409113.91114.16
653764-5376413.82714.08
极限159000-5900015.17415.052.2215.4915.372.25
256858-5685814.62314.94
359011-5901115.17715.50
456921-5692114.63914.93
559813-5981315.38315.71
659493-5949315.30115.63
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