坎地沙坦酯左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
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%
114.234266842475426664260442519425860.21
214.304246642712425890.41
单位质量响应值RSD%判断
2992.692978.250.35数据可信
长期3月-供试品溶液-2024042711批-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min143803-4380392.63793.961.6592.6493.961.65
244075-4407593.21293.21
343880-4388092.80092.80
444841-4484194.83294.83
544258-4425893.59993.60
645710-4571096.67096.67
10min146315-4631597.94997.851.7498.9898.891.74
246290-4629097.89798.93
344905-4490594.96796.00
447094-4709499.597100.65
545956-4595697.19098.23
647036-4703699.474100.55
15min145768-4576896.79397.740.9398.9199.870.93
245862-4586296.99199.11
345873-4587397.01599.10
446693-4669398.749100.91
546491-4649198.322100.44
646618-4661898.590100.77
20min145180-4518095.54996.371.7298.7499.591.71
245271-4527195.74298.94
344543-4454394.20297.37
446727-4672798.821102.08
545466-4546696.15499.37
646217-4621797.742101.02
30min143251-4325191.47093.811.7695.7298.091.74
244644-4464494.41698.68
343757-4375792.54096.75
445194-4519495.57999.93
544140-4414093.35097.63
645153-4515395.49299.85
45min143697-4369792.41392.731.2497.6898.061.24
243890-4389092.82198.13
343268-4326891.50596.74
444668-4466894.46699.88
543318-4331891.61196.93
644246-4424693.57499.00
60min142329-4232989.52090.801.3495.8297.161.33
243258-4325891.48497.83
342137-4213789.11495.37
443584-4358492.17498.64
543047-4304791.03897.37
643257-4325791.48297.94
极限141727-4172788.24689.711.6295.5497.081.58
242469-4246989.81697.18
341559-4155987.89195.14
442661-4266190.22297.71
542672-4267290.24597.59
643415-4341591.81699.29
坎地沙坦酯左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
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%
114.234263942521427634265742752426660.24
214.304292842608427680.53
单位质量响应值RSD%判断
2998.312990.770.18数据可信
加速3月-供试品溶液-2024042711批-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min143757-4375792.25989.995.1892.2689.995.18
244576-4457693.98693.99
343394-4339491.49491.49
438416-3841680.99881.00
542351-4235189.29489.29
643589-4358991.90591.90
10min143575-4357591.87592.631.6992.9093.631.70
244960-4496094.79595.84
343689-4368992.11693.13
443024-4302490.71391.61
544696-4469694.23995.23
643649-4364992.03193.05
15min142544-4254489.70191.531.4791.7593.561.46
244390-4439093.59495.69
343092-4309290.85792.90
443236-4323691.16093.07
543826-4382692.40494.44
643374-4337491.45193.50
20min141909-4190988.36390.392.0691.4193.442.03
243979-4397992.72795.86
342850-4285090.34793.40
442396-4239689.38992.31
543896-4389692.55295.62
642203-4220388.98292.04
30min142496-4249689.60089.120.5393.6293.170.58
242370-4237089.33593.50
342228-4222889.03593.09
441852-4185288.24292.16
542373-4237389.34193.44
642282-4228289.14993.20
45min141990-4199088.53388.401.0593.5593.441.06
242451-4245189.50594.67
341764-4176488.05793.10
441615-4161587.74392.64
542404-4240489.40694.49
641348-4134887.18092.22
60min140940-4094086.31986.062.2192.3292.082.10
240342-4034285.05991.21
340815-4081586.05692.08
440240-4024084.84490.71
542510-4251089.63095.71
640045-4004584.43290.44
极限141149-4114986.76086.002.6693.7292.972.54
241691-4169187.90395.00
340810-4081086.04593.02
440130-4013084.61291.42
541931-4193188.40995.49
639007-3900782.24489.19
坎地沙坦酯左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
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%
114.234257442721423464231142454424810.40
214.304269042325425080.61
单位质量响应值RSD%判断
2985.312972.590.31数据可信
长期3月-供试品溶液-24041103批-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min146475-4647598.50398.881.0798.5098.881.07
247467-47467100.605100.61
346435-4643598.41898.42
446391-4639198.32598.32
547019-4701999.65699.66
646120-4612097.75097.75
10min145907-4590797.29998.151.4598.3999.251.44
246931-4693199.469100.59
345502-4550296.44197.53
446705-4670598.990100.08
547061-4706199.745100.85
645757-4575796.98198.07
15min145572-4557296.58996.631.1498.7698.821.14
246431-4643198.410100.63
345102-4510295.59397.76
445915-4591597.31699.51
545471-4547196.37598.59
645062-4506295.50897.67
20min144204-4420493.69094.961.4396.9498.231.42
245577-4557796.60099.92
344186-4418693.65196.88
445014-4501495.40698.68
545488-4548896.41199.70
644360-4436094.02097.25
30min144305-4430593.90493.861.2098.1998.181.19
244786-4478694.92399.31
343637-4363792.48896.76
444812-4481294.97899.31
544518-4451894.35598.71
643653-4365392.52296.79
45min143117-4311791.38692.450.8296.7297.810.81
243901-4390193.04798.49
343372-4337291.92697.22
444102-4410293.47398.86
543645-4364592.50597.91
643573-4357392.35297.65
60min142589-4258990.26791.371.4096.6297.761.37
243749-4374992.72599.20
342967-4296791.06897.38
443602-4360292.41498.84
543485-4348592.16698.60
642257-4225789.56395.89
极限142241-4224189.52990.481.2496.8897.891.22
242889-4288990.90298.41
342165-4216589.36896.70
443005-4300591.14898.60
543501-4350192.20099.66
642345-4234589.74997.07
坎地沙坦酯左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
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%
114.234241742313425114241742515424350.20
214.304255142535425430.03
单位质量响应值RSD%判断
2982.082975.030.17数据可信
加速3月-供试品溶液-24041103批-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min147175-4717599.99997.701.61100.0097.701.61
246088-4608897.69597.70
345796-4579697.07697.08
445622-4562296.70796.71
545162-4516295.73295.73
646708-4670899.00999.01
10min146388-4638898.33197.551.4399.4498.641.43
246773-4677399.147100.23
346036-4603697.58598.66
445203-4520395.81996.89
545264-4526495.94897.01
646467-4646798.49999.60
15min145228-4522895.87296.221.8298.0898.391.79
246831-4683199.270101.46
344532-4453294.39796.56
444812-4481294.99097.13
545154-4515495.71597.85
645784-4578497.05199.25
20min145288-4528895.99994.351.4599.2797.591.44
245237-4523795.89199.18
343835-4383592.91996.13
443831-4383192.91196.11
544370-4437094.05397.25
644503-4450394.33597.61
30min144313-4431393.93393.491.8698.2797.771.82
244749-4474994.85799.21
343450-4345092.10396.35
443724-4372492.68496.91
543120-4312091.40495.64
645258-4525895.936100.26
45min143503-4350392.21691.231.1997.5996.561.19
243417-4341792.03397.44
343010-4301091.17196.44
442110-4211089.26394.52
542896-4289690.92996.18
643297-4329791.77997.17
60min142298-4229889.66191.271.2196.0797.601.17
243735-4373592.70799.14
342950-4295091.04397.32
443096-4309691.35397.60
542741-4274190.60096.86
643512-4351292.23598.64
极限142024-4202489.08089.251.7196.4896.601.65
242438-4243889.95897.42
342092-4209289.22596.52
441291-4129187.52794.79
541492-4149287.95395.22
643294-4329491.77399.20
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