比索洛尔氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
对照品批号100711-202203对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.078190381952818958190881932819180.03
210.068170981726817180.02
单位质量响应值RSD%判断
8134.868123.060.11数据可信
中间条件3月-供试品溶液-2024021621批-比索洛尔-0.005hcl
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min186480-8648095.55596.681.5495.5696.681.54
286298-8629895.35495.35
386742-8674295.84595.84
487288-8728896.44896.45
588399-8839997.67697.68
689759-8975999.17899.18
10min189177-8917798.53599.130.7898.6999.300.78
288996-8899698.33598.49
389804-8980499.22899.39
489496-8949698.88899.05
589908-8990899.34399.51
690934-90934100.477100.64
15min189722-8972299.13799.420.4699.4699.740.46
289375-8937598.75499.08
390261-9026199.733100.06
489874-8987499.30599.63
590109-9010999.56599.89
690513-90513100.011100.34
20min189512-8951298.90599.110.5999.3999.600.59
289098-8909898.44898.94
389776-8977699.19799.69
489458-8945898.84699.34
589685-8968599.09699.59
690666-90666100.180100.68
30min189085-8908598.43499.100.6899.0999.760.68
289146-8914698.50199.15
389906-8990699.341100.00
489326-8932698.70099.36
590023-9002399.470100.13
690626-90626100.136100.80
45min188967-8896798.30398.730.6699.1299.550.66
288552-8855297.84598.66
389416-8941698.79999.62
489185-8918598.54499.36
589809-8980999.233100.06
690183-9018399.647100.48
极限188569-8856997.86398.430.7298.8499.420.72
288491-8849197.77798.76
389348-8934898.72499.71
488707-8870798.01699.00
589205-8920598.56699.56
690171-9017199.633100.63
比索洛尔氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
对照品批号100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.851027011026311024541030411028321027320.22
213.971021821019911020860.14
单位质量响应值RSD%判断
7417.477307.521.06数据可信
中间条件3月-供试品溶液-2024021621批-氨氯地平-0.005hcl
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min199965-9996588.02290.193.1488.0290.193.14
298461-9846186.69886.70
3103246-10324690.91190.91
4101304-10130489.20189.20
5104204-10420491.75491.75
6107400-10740094.56994.57
10min1107358-10735894.53295.412.3794.6895.572.37
2104578-10457892.08492.23
3109750-10975096.63896.79
4107502-10750294.65894.81
5108790-10879095.79295.95
6112181-11218198.77898.94
15min1109343-10934396.27996.851.5996.5897.151.59
2107214-10721494.40594.70
3111852-11185298.48998.80
4109451-10945196.37596.68
5110289-11028997.11297.42
6111775-11177598.42198.74
20min1110365-11036597.17997.181.6097.6497.651.60
2107890-10789095.00095.46
3112094-11209498.70299.18
4108731-10873195.74196.21
5110841-11084197.59898.07
6112243-11224398.83399.32
30min1110821-11082197.58197.780.9798.2198.420.98
2110275-11027597.10097.71
3112295-11229598.87999.52
4109966-10996696.82897.45
5110468-11046897.27097.91
6112473-11247399.03599.69
45min1111086-11108697.81497.811.0298.6098.601.03
2109695-10969596.58997.36
3112846-11284699.364100.17
4110197-11019797.03197.82
5110861-11086197.61698.42
6111801-11180198.44499.26
极限1110314-11031497.13497.551.6598.0998.511.65
2109199-10919996.15397.09
3113377-11337799.831100.80
4109352-10935296.28797.24
5109702-10970296.59697.56
6112768-11276899.295100.28
比索洛尔氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
对照品批号100711-202203对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.078208081932820458208781983820250.09
210.068158781541815640.04
单位质量响应值RSD%判断
8145.488107.750.33数据可信
中间条件3月-供试品溶液-2024021821批-比索洛尔-0.005hcl
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min186397-8639795.49196.452.8295.4996.452.82
284061-8406192.90992.91
384944-8494493.88593.89
489471-8947198.88998.89
589209-8920998.59998.60
689505-8950598.92798.93
10min192570-92570102.314101.372.99102.47101.532.99
287797-8779797.03997.19
388786-8878698.13298.29
494455-94455104.398104.56
593064-93064102.860103.02
693610-93610103.464103.63
15min193049-93049102.844101.763.16103.17102.093.16
287629-8762996.85397.17
389223-8922398.61598.93
494537-94537104.488104.83
593890-93890103.773104.11
694081-94081103.984104.32
20min192901-92901102.680101.583.18103.18102.083.18
287519-8751996.73197.21
388972-8897298.33798.82
494422-94422104.361104.87
593559-93559103.407103.92
694089-94089103.993104.50
30min192867-92867102.642101.183.11103.31101.843.11
287111-8711196.28196.92
388882-8888298.23898.89
494200-94200104.116104.80
592982-92982102.770103.45
693201-93201103.012103.70
45min192584-92584102.330101.073.02103.17101.913.03
287187-8718796.36597.16
388783-8878398.12998.94
493902-93902103.786104.65
592915-92915102.695103.55
693293-93293103.113103.97
极限192499-92499102.236101.093.33103.25102.103.33
286890-8689096.03697.00
388416-8841697.72398.70
494233-94233104.152105.19
593186-93186102.995104.02
693550-93550103.397104.42
比索洛尔氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
对照品批号100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.851025411013311027951022431025851022990.57
213.971025851015031020440.75
单位质量响应值RSD%判断
7386.217304.510.79数据可信
中间条件3月-供试品溶液-2024021821批-氨氯地平-0.005hcl
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1100405-10040588.61387.101.3088.6187.101.30
299997-9999788.25388.25
398495-9849586.92886.93
498278-9827886.73686.74
597067-9706785.66785.67
697878-9787886.38386.38
10min1112231-11223199.05097.061.9899.2097.201.98
2112509-11250999.29699.44
3110457-11045797.48597.63
4109180-10918096.35896.50
5106992-10699294.42794.57
6108473-10847395.73495.88
15min1115115-115115101.59698.981.70101.9199.291.71
2113198-11319899.904100.22
3112365-11236599.16999.48
4111887-11188798.74799.05
5109742-10974296.85497.15
6110610-11061097.62097.92
20min1116608-116608102.913100.001.70103.40100.481.70
2113522-113522100.190100.67
3114083-114083100.685101.16
4112536-11253699.32099.79
5111207-11120798.14798.61
6111905-11190598.76399.23
30min1116191-116191102.545100.351.60103.20100.991.60
2112245-11224599.06399.71
3115650-115650102.068102.71
4113706-113706100.352100.99
5112312-11231299.12299.75
6112124-11212498.95699.59
45min1116090-116090102.456100.671.30103.28101.471.30
2113307-113307100.000100.81
3115772-115772102.176102.99
4112549-11254999.331100.13
5113288-11328899.983100.77
6113376-113376100.061100.86
极限1116765-116765103.052100.961.82104.05101.931.81
2111580-11158098.47699.45
3116290-116290102.633103.61
4115471-115471101.910102.88
5113390-113390100.073101.03
6112878-11287899.621100.58
比索洛尔氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
对照品批号100711-202203对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.078173981785818618187281854818220.08
210.068216382124821440.04
单位质量响应值RSD%判断
8125.328165.410.35数据可信
中间条件3月-供试品溶液-2024022021批-比索洛尔-0.005hcl
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min192254-92254101.73099.201.71101.7399.201.71
290022-9002299.26999.27
388128-8812897.18097.18
490739-90739100.060100.06
590232-9023299.50199.50
688392-8839297.47297.47
10min192996-92996102.54999.681.84102.7299.851.84
290273-9027399.54699.71
388514-8851497.60697.77
491002-91002100.350100.52
590862-90862100.195100.36
688727-8872797.84198.00
15min192488-92488101.98899.561.80102.3399.891.80
290120-9012099.37799.71
388438-8843897.52297.85
491661-91661101.076101.41
590422-9042299.710100.04
688569-8856997.66797.99
20min192201-92201101.67299.461.66102.1899.961.66
290182-9018299.44599.94
388071-8807197.11897.60
491177-91177100.543101.05
590579-9057999.883100.38
688968-8896898.10798.60
30min192320-92320101.80399.241.94102.4899.911.94
289695-8969598.90899.57
387851-8785196.87597.52
491120-91120100.480101.15
590795-90795100.121100.79
688220-8822097.28297.93
45min192041-92041101.49599.101.70102.3499.921.70
290027-9002799.275100.10
388131-8813197.18497.99
490783-90783100.108100.95
590072-9007299.324100.16
688139-8813997.19398.01
极限192083-92083101.54298.731.98102.5699.721.98
289554-8955498.75399.75
387583-8758396.57997.55
490483-9048399.777100.78
589986-8998699.229100.23
687491-8749196.47897.45
比索洛尔氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
对照品批号100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.851023221021101021431024071022821022530.13
213.971025221031181028200.41
单位质量响应值RSD%判断
7382.897360.060.22数据可信
中间条件3月-供试品溶液-2024022021批-氨氯地平-0.005hcl
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1106353-10635393.52898.194.3093.5398.194.30
2115581-115581101.643101.64
3119065-119065104.707104.71
4108425-10842595.35095.35
5109263-10926396.08796.09
6111216-11121697.80497.80
10min1109864-10986496.615100.203.6196.77100.363.62
2116331-116331102.302102.47
3120518-120518105.984106.16
4110582-11058297.24797.41
5111360-11136097.93198.09
6114966-114966101.102101.26
15min1108604-10860495.50799.913.7895.82100.243.78
2116250-116250102.231102.57
3120282-120282105.777106.13
4110944-11094497.56597.89
5110942-11094297.56397.89
6114629-114629100.806101.14
20min1107854-10785494.84898.853.6695.3299.353.67
2116175-116175102.165102.68
3118242-118242103.983104.51
4109421-10942196.22696.71
5109856-10985696.60897.09
6112888-11288899.27599.77
30min1107791-10779194.79298.603.7395.4399.263.74
2114631-114631100.807101.49
3118551-118551104.255104.96
4109147-10914795.98596.63
5108979-10897995.83796.48
6113634-11363499.931100.60
45min1106616-10661693.75998.583.9094.5599.403.89
2115673-115673101.724102.57
3118427-118427104.146105.02
4109568-10956896.35597.16
5109739-10973996.50597.31
6112565-11256598.99099.82
极限1107971-10797194.95098.653.5295.9099.643.52
2114315-114315100.529101.55
3118880-118880104.544105.59
4109740-10974096.50697.47
5110017-11001796.75097.72
6112162-11216298.63699.63
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