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%
111.984746747959478074755147262476090.59
212.034744147490474660.08
单位质量响应值RSD%判断
3974.043945.640.51数据可信
供试品溶液-24111401SP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%
5min133921-3392169.23067.642.5969.2367.642.60
232216-3221665.75165.75
333143-3314367.64367.64
434302-3430270.00870.01
533057-3305767.46767.47
632211-3221165.74065.74
10min143857-4385789.50989.111.2589.8989.491.25
244105-4410590.01590.38
343318-4331888.40988.78
444418-4441890.65491.04
543067-4306787.89788.27
643214-4321488.19788.56
15min144342-4434290.49988.372.1791.3889.242.16
243822-4382289.43890.30
342930-4293087.61788.48
444089-4408989.98390.88
542695-4269587.13888.00
641919-4191985.55486.41
20min143462-4346288.70387.601.5290.0988.961.51
243270-4327088.31189.67
343567-4356788.91790.27
442904-4290487.56488.96
541916-4191685.54886.89
642411-4241186.55887.89
30min143246-4324688.26286.872.2990.1488.722.27
242961-4296187.68189.53
341185-4118584.05685.90
443866-4386689.52891.41
541942-4194285.60187.42
642185-4218586.09787.91
45min142936-4293687.63084.962.1390.0087.292.11
240961-4096183.59985.94
341343-4134384.37886.69
442249-4224986.22788.60
541770-4177085.25087.55
640496-4049682.65084.94
60min143649-4364989.08587.441.2891.9490.241.26
242333-4233386.39989.20
343087-4308787.93890.72
442477-4247786.69389.55
543189-4318988.14690.92
642324-4232486.38089.13
极限144338-4433890.49190.903.2893.8494.193.19
244941-4494191.72295.01
346274-4627494.44297.71
445818-4581893.51196.85
543510-4351088.80192.06
642364-4236486.46289.69
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%
110.323616283605293604333639603610933615290.40
210.363601563620693611120.38
单位质量响应值RSD%判断
35031.8834856.370.36数据可信
供试品溶液-24111401SP批-阿齐沙坦-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%
5min1249828-24982864.15259.7918.3364.1559.7918.33
2167143-16714342.91942.92
3236372-23637260.69660.70
4250527-25052764.33164.33
5290150-29015074.50674.51
6203031-20303152.13552.13
10min1366455-36645594.09993.211.8894.4693.541.91
2362563-36256393.10093.34
3365909-36590993.95994.30
4359961-35996192.43292.79
5371430-37143095.37795.79
6351600-35160090.28590.57
15min1373593-37359395.93293.641.7796.8194.481.78
2367672-36767294.41295.17
3360899-36089992.67393.53
4366541-36654194.12194.99
5364630-36463093.63194.57
6354592-35459291.05391.84
20min1370943-37094395.25293.501.9796.6694.871.96
2368000-36800094.49695.78
3369760-36976094.94896.32
4359520-35952092.31993.71
5364332-36433293.55495.02
6352271-35227190.45791.75
30min1370389-37038995.11093.291.4897.0595.181.48
2366793-36679394.18695.99
3365125-36512593.75895.66
4359459-35945992.30394.21
5362617-36261793.11495.10
6355363-35536391.25193.05
45min1387021-38702199.38094.692.90101.8597.102.87
2369025-36902594.75997.09
3371440-37144095.37997.80
4362808-36280893.16395.58
5367369-36736994.33496.84
6354910-35491091.13593.44
60min1387640-38764099.53995.302.51102.5698.242.50
2369926-36992694.99197.85
3370793-37079395.21398.17
4367580-36758094.38897.33
5371757-37175795.46198.49
6359127-35912792.21895.03
极限1387940-38794099.61699.212.90103.19102.672.85
2387643-38764399.540102.92
3398781-398781102.400105.88
4393975-393975101.166104.63
5383308-38330898.427101.98
6366387-36638794.08297.41
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