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%
112.284919149254496244904549353492930.44
212.294918349175491790.02
单位质量响应值RSD%判断
4014.094001.550.23数据可信
供试品溶液-24050703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%
5min110599-1059921.37351.8362.7421.3751.8362.74
246503-4650393.77293.77
324000-2400048.39648.40
415339-1533930.93130.93
544835-4483590.40990.41
612938-1293826.08926.09
10min144346-4434689.42389.866.2589.5490.146.32
247972-4797296.73597.26
347850-4785096.48996.76
443135-4313586.98187.15
542855-4285586.41686.92
641205-4120583.08983.23
15min147327-4732795.43494.053.8896.0594.843.98
247686-4768696.15897.22
348411-4841197.62098.42
445629-4562992.01092.67
547340-4734095.46096.44
643456-4345687.62888.23
20min147325-4732595.43094.063.0396.5895.373.11
247636-4763696.05797.65
347857-4785796.50397.85
446410-4641093.58594.75
546651-4665194.07195.58
644004-4400488.73389.83
30min145925-4592592.60791.572.2894.2893.412.32
245535-4553591.82093.95
346764-4676494.29996.18
445531-4553191.81293.50
545073-4507390.88992.92
643650-4365088.01989.61
45min147428-4742895.63892.452.3897.8394.782.28
245221-4522191.18793.82
347039-4703994.85397.26
445130-4513091.00493.20
544927-4492790.59493.13
645325-4532591.39793.47
60min147564-4756495.91292.512.2398.6395.362.11
245439-4543991.62794.77
346638-4663894.04596.98
445248-4524891.24293.94
544855-4485590.44993.49
645513-4551391.77694.36
极限147502-4750295.78794.441.5699.0497.811.48
246852-4685294.47698.13
347603-4760395.99099.45
446216-4621693.19496.40
545750-4575092.25495.80
647084-4708494.94498.04
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(%)99.7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%
110.843792333779893781243785353787973785360.14
210.963784663775403780030.18
单位质量响应值RSD%判断
34920.3034489.320.88数据可信
供试品溶液-24050703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%
5min14592-45921.1871.428.841.191.428.79
25938-59381.5351.54
35332-53321.3791.38
45610-56101.4511.45
55663-56631.4641.46
65807-58071.5011.50
10min111282-112822.9173.179.902.923.189.86
214087-140873.6423.65
310745-107452.7782.79
411979-119793.0973.11
512382-123823.2023.21
613083-130833.3833.39
15min121162-211625.4725.5710.295.495.5910.28
223845-238456.1656.19
318195-181954.7054.73
419832-198325.1285.15
522788-227885.8925.92
623393-233936.0496.08
20min129560-295607.6437.666.657.707.726.69
231818-318188.2278.29
326631-266316.8866.93
428212-282127.2957.35
530107-301077.7857.84
631472-314728.1378.20
30min140040-4004010.35310.563.1310.4510.663.18
241660-4166010.77210.88
339266-3926610.15310.24
439947-3994710.32910.42
541462-4146210.72010.82
642624-4262411.02111.13
45min156240-5624014.54213.354.6514.6913.514.57
252013-5201313.44913.62
350711-5071113.11213.26
449634-4963412.83312.99
550192-5019212.97813.14
650971-5097113.17913.35
60min157572-5757214.88614.731.0515.1214.961.07
257290-5729014.81315.06
357398-5739814.84115.06
456001-5600114.48014.70
556536-5653614.61814.85
657081-5708114.75915.00
极限161308-6130815.85216.041.7016.1716.351.69
263877-6387716.51616.84
362458-6245816.14916.45
461152-6115215.81216.11
562174-6217416.07616.39
661218-6121815.82916.15
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%
112.284907149164490494913849294491430.20
212.294963549635496350.00
单位质量响应值RSD%判断
4001.874038.650.65数据可信
供试品溶液-24050703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%
5min146729-4672993.93891.094.7593.9491.094.75
242716-4271685.87185.87
347242-4724294.96994.97
447168-4716894.82194.82
545384-4538491.23491.23
642625-4262585.68885.69
10min149004-4900498.51296.332.7199.0396.832.71
245529-4552991.52692.00
349119-4911998.74399.27
447822-4782296.13596.66
548162-4816296.81997.33
647867-4786796.22696.70
15min149280-4928099.06696.902.56100.1497.942.56
246488-4648893.45494.44
348777-4877798.05599.13
449027-4902798.55899.62
548868-4886898.23899.28
646782-4678294.04595.06
20min148972-4897298.44796.552.21100.0798.132.23
246431-4643193.33994.84
348847-4884798.19699.82
448235-4823596.96698.57
548681-4868197.86299.45
647008-4700894.49996.03
30min147424-4742495.33593.482.1197.5095.602.12
245365-4536591.19693.22
347358-4735895.20397.37
446600-4660093.67995.83
547036-4703694.55596.69
645234-4523490.93392.99
45min147028-4702894.53993.041.0697.2495.681.09
245880-4588092.23194.76
346435-4643593.34796.04
446115-4611592.70495.37
546548-4654893.57496.23
645694-4569491.85794.42
60min146786-4678694.05393.441.8497.2796.591.86
245449-4544991.36594.41
347057-4705794.59797.81
447159-4715994.80397.99
547099-4709994.68297.86
645330-4533091.12694.20
极限147386-4738695.25993.131.5999.0096.801.60
245106-4510690.67594.23
346558-4655893.59497.33
446301-4630193.07896.79
546427-4642793.33197.04
646191-4619192.85796.44
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(%)99.7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%
110.843773333765323770333770283777933771440.13
210.963827453828683828060.03
单位质量响应值RSD%判断
34791.8834927.550.28数据可信
供试品溶液-24050703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%
5min15115-51151.3171.429.941.321.429.95
25735-57351.4761.48
36156-61561.5851.58
44793-47931.2341.23
55251-52511.3521.35
66058-60581.5591.56
10min111613-116132.9893.1411.743.003.1511.69
210959-109592.8212.83
314841-148413.8203.83
412720-127203.2743.28
511748-117483.0243.03
611256-112562.8972.91
15min121983-219835.6595.4612.705.685.4812.65
218691-186914.8114.84
326009-260096.6956.72
421193-211935.4555.48
520539-205395.2875.31
618801-188014.8394.86
20min130541-305417.8617.658.467.927.718.46
227546-275467.0907.14
334209-342098.8068.87
429868-298687.6887.74
528754-287547.4017.46
627474-274747.0727.12
30min142166-4216610.85410.435.1510.9510.535.19
239197-3919710.08910.18
343979-4397911.32011.44
439753-3975310.23310.33
539104-3910410.06610.16
638869-3886910.00510.10
45min151746-5174613.32013.183.0113.4813.343.03
250179-5017912.91613.06
352147-5214713.42313.60
453566-5356613.78813.94
550245-5024512.93313.08
649434-4943412.72512.87
60min157896-5789614.90314.742.1715.1414.982.24
256255-5625514.48014.70
359447-5944715.30215.56
456855-5685514.63514.87
557118-5711814.70214.92
656113-5611314.44414.66
极限161256-6125615.76815.541.8416.0815.851.89
259330-5933015.27215.57
362130-6213015.99316.33
459887-5988715.41515.73
560223-6022315.50215.81
659421-5942115.29515.59
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