苯磺酸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)5供试品稀释倍数4系数0.721
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.263784938044379473786337859379120.23
213.303795237863379080.17
单位质量响应值RSD%判断
2859.132850.230.23数据可信
供试品溶液-8153342批-水
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min129947-2994766.23562.663.4066.2462.663.40
228726-2872663.53563.53
328317-2831762.63062.63
427486-2748660.79260.79
527264-2726460.30160.30
628254-2825462.49162.49
10min144292-4429297.96394.182.8698.7094.872.85
243339-4333995.85596.56
343160-4316095.45996.15
441547-4154791.89192.57
542029-4202992.95793.63
641114-4111490.93491.63
15min145957-45957101.64597.822.11103.4799.562.11
243933-4393397.16998.94
344165-4416597.68299.44
444008-4400897.33499.03
544173-4417397.69999.40
643130-4313095.39397.10
20min145973-45973101.68198.282.28104.63101.112.27
245011-4501199.553102.40
343841-4384196.96599.81
443810-4381096.89799.67
544786-4478699.055101.84
643193-4319395.53298.30
30min145919-45919101.56198.002.38105.64101.922.36
244955-4495599.429103.39
343148-4314895.43299.35
444201-4420197.761101.62
544400-4440098.201102.09
643232-4323295.61899.44
45min145808-45808101.31698.392.50106.53103.402.47
245192-4519299.953105.01
343902-4390297.100102.08
443609-4360996.452101.39
545350-45350100.303105.28
643050-4305095.216100.10
极限144960-4496099.44096.762.10105.78102.862.11
244591-4459198.624104.80
343276-4327695.715101.77
443078-4307895.278101.29
543973-4397397.257103.35
642608-4260894.238100.18
苯磺酸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)5供试品稀释倍数4系数0.721
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.263805638058380973808537999380590.10
213.303806537965380150.19
单位质量响应值RSD%判断
2870.212858.270.30数据可信
供试品溶液-8153342批-水
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min138558-3855884.99680.474.0885.0080.484.08
237880-3788083.50183.50
336006-3600679.37079.37
436449-3644980.34780.35
535630-3563078.54178.54
634518-3451876.09076.09
10min144213-4421397.46194.192.3198.4195.082.31
242186-4218692.99393.92
343487-4348795.86196.74
442756-4275694.25095.14
542243-4224393.11993.99
641486-4148691.45092.30
15min144881-4488198.93496.451.53100.9698.391.55
243617-4361796.14898.11
343844-4384496.64898.60
443978-4397896.94398.88
543214-4321495.25997.17
642989-4298994.76396.62
20min144741-4474198.62596.301.34101.7599.311.36
243688-4368896.30499.33
343134-4313495.08398.10
443716-4371696.36699.38
543688-4368896.30499.27
643150-4315095.11898.03
30min143560-4356096.02295.581.46100.2499.671.44
243177-4317795.17899.28
344307-4430797.669101.75
443503-4350395.89699.98
543252-4325295.34399.38
642371-4237193.40197.37
45min143416-4341695.70594.111.33100.9999.251.33
242707-4270794.14299.30
342136-4213692.88398.05
443245-4324595.328100.48
542615-4261593.93999.03
642024-4202492.63697.65
极限142451-4245193.57792.730.9799.9398.920.99
241928-4192892.42498.63
341794-4179492.12998.32
442632-4263293.976100.19
542032-4203292.65498.79
641557-4155791.60797.65
苯磺酸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)5供试品稀释倍数4系数0.721
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.263805538080380383808438025380560.07
213.303800238021380120.04
单位质量响应值RSD%判断
2869.982858.050.30数据可信
供试品溶液-8153342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%
5min147045-47045103.712103.262.03103.71103.262.03
245201-4520199.64799.65
348002-48002105.822105.82
446602-46602102.736102.74
546756-46756103.075103.08
647443-47443104.590104.59
10min146215-46215101.883100.132.07103.03101.282.06
244113-4411397.24998.36
346253-46253101.966103.14
444456-4445698.00599.15
545422-45422100.134101.28
646066-46066101.554102.72
15min145916-45916101.22399.362.25103.51101.622.24
243326-4332695.51497.70
345669-45669100.679102.99
444389-4438997.857100.09
545723-45723100.798103.06
645398-45398100.082102.37
20min145531-45531100.37598.441.84103.78101.801.84
243648-4364896.22499.47
345205-4520599.656103.08
443611-4361196.14299.46
544967-4496799.131102.51
644963-4496399.123102.53
30min145092-4509299.40796.982.57103.93101.432.53
242541-4254193.78398.10
344978-4497899.156103.69
442860-4286094.48698.87
544815-4481598.796103.28
643650-4365096.228100.73
45min144024-4402497.05296.062.40102.68101.602.38
242036-4203692.67098.03
344659-4465998.452104.09
442537-4253793.77499.21
544303-4430397.668103.24
643893-4389396.764102.34
极限143850-4385096.66995.292.23103.38101.902.22
241949-4194992.47898.87
344580-4458098.278105.01
442367-4236793.40099.88
543184-4318495.201101.86
643428-4342895.739102.39
苯磺酸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)5供试品稀释倍数4系数0.721
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.263806238052380763781437996380000.29
213.303869038879387840.35
单位质量响应值RSD%判断
2865.762916.091.24数据可信
供试品溶液-8153342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%
5min146527-46527101.62399.302.27101.6299.302.27
243681-4368195.40795.41
345248-4524898.82998.83
445181-4518198.68398.68
546345-46345101.225101.23
645790-45790100.013100.01
10min146684-46684101.966100.472.06103.09101.572.06
244493-4449397.18098.24
347133-47133102.947104.04
445839-45839100.120101.22
546377-46377101.295102.42
645458-4545899.288100.40
15min147793-47793104.38899.732.77106.65101.952.75
244433-4443397.04999.19
346417-46417101.383103.62
444607-4460797.42999.64
545554-4555499.498101.75
645166-4516698.650100.86
20min145912-45912100.28098.321.73103.70101.641.74
243613-4361395.25898.48
345455-4545599.281102.65
444957-4495798.194101.49
544907-4490798.085101.44
645234-4523498.799102.11
30min144964-4496498.20997.541.56102.75101.961.56
243547-4354795.11499.39
345588-4558899.572104.04
444779-4477997.805102.19
544242-4424296.632101.08
644814-4481497.881102.29
45min145265-4526598.86697.002.35104.49102.502.32
242448-4244892.71498.05
345261-4526198.858104.44
444400-4440096.977102.45
544752-4475297.746103.27
644326-4432696.816102.31
极限145098-4509898.50296.151.84105.23102.741.84
242827-4282793.54199.91
344680-4468097.589104.27
443545-4354595.110101.66
544030-4403096.169102.77
643954-4395496.003102.57
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