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%
113.263693337101372593728537089371330.39
213.303707537125371000.10
单位质量响应值RSD%判断
2800.382789.470.28数据可信
供试品溶液-8165511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%
5min146652-46652105.388103.502.91105.39103.502.91
243505-4350598.27998.28
346312-46312104.620104.62
445435-45435102.639102.64
547363-47363106.994106.99
645631-45631103.082103.08
10min146111-46111104.166101.782.85105.34102.942.85
242741-4274196.55397.65
344816-44816101.241102.40
445205-45205102.119103.26
546343-46343104.690105.88
645121-45121101.930103.08
15min145556-45556102.912101.033.09105.24103.313.08
242053-4205394.99997.16
344673-44673100.918103.21
445707-45707103.253105.53
545577-45577102.960105.31
644760-44760101.114103.39
20min144635-44635100.83299.872.95104.30103.272.94
241716-4171694.23897.46
343907-4390799.187102.60
444695-44695100.967104.39
545114-45114101.914105.41
645188-45188102.081105.48
30min144214-4421499.88199.032.50104.47103.542.51
241698-4169894.19798.46
343774-4377498.887103.40
444434-44434100.378104.92
544718-44718101.019105.65
644175-4417599.793104.33
45min143800-4380098.94697.492.99104.65103.102.98
240566-4056691.64096.95
343354-4335497.938103.55
443683-4368398.681104.34
544021-4402199.445105.20
643506-4350698.281103.93
极限144119-4411999.66697.233.01106.47103.932.98
240525-4052591.54797.88
343120-4312097.409104.11
443145-4314597.466104.22
543501-4350198.270105.13
643829-4382999.011105.75
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%
113.263688137019369803697236940369580.14
213.303708037106370930.05
单位质量响应值RSD%判断
2787.182788.950.05数据可信
供试品溶液-8165511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%
5min145290-45290102.563103.861.38102.56103.861.38
246699-46699105.754105.75
346044-46044104.270104.27
446445-46445105.179105.18
545167-45167102.284102.28
645530-45530103.106103.11
10min144617-44617101.039101.921.16102.18103.071.16
245277-45277102.533103.71
345169-45169102.289103.45
445735-45735103.571104.74
544976-44976101.852102.99
644251-44251100.210101.36
15min144240-44240100.185100.621.62102.45102.911.61
245151-45151102.248104.56
343992-4399299.623101.92
445341-45341102.678105.00
544449-44449100.658102.93
643426-4342698.342100.60
20min143443-4344398.38099.401.29101.76102.811.28
244530-44530100.842104.29
343632-4363298.808102.21
444557-44557100.903104.36
543990-4399099.619103.01
643214-4321497.862101.21
30min142608-4260896.48997.931.45100.96102.441.43
243171-4317197.764102.34
343270-4327097.988102.49
444242-44242100.190104.77
543589-4358998.711103.20
642585-4258596.437100.88
45min142385-4238595.98497.661.74101.52103.261.71
243777-4377799.137104.79
343278-4327898.007103.60
443838-4383899.275104.97
543449-4344998.394103.98
642030-4203095.180100.69
极限142051-4205195.22896.081.05101.84102.761.05
242298-4229895.787102.55
342731-4273196.768103.45
443109-4310997.624104.42
542445-4244596.120102.80
641918-4191894.927101.49
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%
113.263702437042371123699637098370540.14
213.303694836893369200.11
单位质量响应值RSD%判断
2794.422775.940.47数据可信
供试品溶液-8165511批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min144516-44516100.916100.151.66100.92100.151.66
242877-4287797.20097.20
344911-44911101.811101.81
444118-44118100.013100.01
543962-4396299.66099.66
644693-44693101.317101.32
10min145376-45376102.865101.282.01103.99102.402.01
243310-4331098.18299.26
345894-45894104.039105.17
444269-44269100.356101.47
544542-44542100.975102.08
644673-44673101.272102.40
15min145333-45333102.768100.892.29105.03103.132.27
242816-4281697.06299.23
345336-45336102.775105.06
444809-44809101.580103.81
544998-44998102.008104.24
643736-4373699.147101.40
20min144745-44745101.43599.691.85104.84103.051.84
242568-4256896.50099.75
344802-44802101.564104.99
443910-4391099.542102.90
543855-4385599.417102.78
643981-4398199.703103.06
30min144334-44334100.50398.192.09105.04102.662.07
241626-4162694.36498.69
343657-4365798.968103.53
443321-4332198.207102.67
543419-4341998.429102.90
643524-4352498.667103.13
45min143511-4351198.63797.491.93104.29103.051.92
241446-4144693.95699.33
343583-4358398.801104.46
442755-4275596.924102.48
543175-4317597.876103.44
643554-4355498.735104.29
极限143132-4313297.77896.582.18104.52103.222.14
241239-4123993.48799.90
343666-4366698.989105.74
441882-4188294.944101.57
542418-4241896.160102.81
643282-4328298.118104.77
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%
113.263719837364372273720437146372280.22
213.303710537142371240.08
单位质量响应值RSD%判断
2807.542791.280.42数据可信
供试品溶液-8165511批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min142382-4238295.58994.412.8595.5994.422.85
242888-4288896.73196.73
343053-4305397.10397.10
441724-4172494.10594.11
541239-4123993.01193.01
639881-3988189.94889.95
10min143285-4328597.62696.332.9898.6997.382.98
243424-4342497.93999.01
344323-4432399.967101.05
442848-4284896.64097.69
541322-4132293.19994.23
641066-4106692.62193.62
15min142037-4203794.81195.542.5596.9697.662.55
243686-4368698.530100.69
343561-4356198.248100.44
442143-4214395.05097.17
541886-4188694.47196.54
640859-4085992.15494.18
20min142041-4204194.82094.832.8698.0298.012.86
243070-4307097.141100.40
343752-4375298.679101.96
441867-4186794.42897.60
540716-4071691.83294.95
640834-4083492.09895.15
30min141703-4170394.05894.093.1098.3198.323.07
242294-4229495.39199.73
343822-4382298.837103.21
441676-4167693.99798.22
540614-4061491.60295.74
640188-4018890.64194.72
45min141415-4141593.40893.423.0498.7198.703.02
242720-4272096.352101.75
343121-4312197.256102.73
440858-4085892.15297.42
540292-4029290.87596.03
640108-4010890.46095.54
极限140516-4051691.38192.243.3297.7298.563.28
242203-4220395.186101.65
342759-4275996.440103.00
440890-4089092.22498.52
539545-3954589.19195.36
639464-3946489.00895.10
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