左氨氯地平叶酸片项目信息
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5000
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%
117.34 1888701887671888361881571887691886800.16
217.421884441878961881700.21
单位质量响应值RSD%判断
10881.2010801.950.52数据可信
供试品溶液-24082901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%
5min1107702-107702100.357102.761.43100.36102.761.42
2112116-112116104.470104.47
3109946-109946102.448102.45
4109916-109916102.420102.42
5111697-111697104.080104.08
6110282-110282102.761102.76
10min1108276-108276100.892102.821.37102.01103.971.36
2111255-111255103.668104.83
3108619-108619101.211102.35
4111471-111471103.869105.01
5111655-111655104.040105.20
6110821-110821103.263104.41
15min1107500-107500100.169102.521.41102.40104.801.40
2111188-111188103.605105.92
3108830-108830101.408103.67
4111371-111371103.776106.07
5110946-110946103.380105.69
6110286-110286102.765105.05
20min1106227-10622798.983101.091.41102.33104.511.40
2109120-109120101.678105.14
3107399-107399100.075103.46
4110673-110673103.125106.57
5108931-108931101.502104.96
6108557-108557101.154104.58
30min1105583-10558398.383100.251.46102.83104.801.45
2108984-108984101.552106.15
3105900-10590098.678103.18
4109368-109368101.909106.50
5108153-108153100.777105.37
6107554-107554100.219104.77
45min1104100-10410097.00199.291.34102.54104.941.33
2108029-108029100.662106.38
3106099-10609998.863104.46
4107469-107469100.140105.86
5106209-10620998.966104.67
6107411-107411100.086105.75
60min1102445-10244595.45997.841.30102.08104.601.29
2105231-10523198.055104.89
3105059-10505997.894104.59
4106534-10653499.269106.10
5105202-10520298.028104.84
6105544-10554498.346105.13
90min1102500-10250095.51097.421.26103.19105.271.26
2105603-10560398.401106.33
3103440-10344096.386104.17
4105715-10571598.506106.44
5105338-10533898.154106.05
6104715-10471597.574105.45
极限1102035-10203595.07696.101.07103.82105.031.07
2104231-10423197.123106.15
3102079-10207995.117103.97
4104496-10449697.370106.40
5103499-10349996.441105.43
6102454-10245495.467104.42
左氨氯地平叶酸片项目信息
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5000
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%
117.34 1885401888401881981887211879311884460.20
217.421886191883291884740.11
单位质量响应值RSD%判断
10867.7010819.400.32数据可信
供试品溶液-24082901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%
5min1114768-114768106.921103.162.02106.92103.162.02
2109089-109089101.630101.63
3111721-111721104.082104.08
4109091-109091101.632101.63
5109246-109246101.776101.78
6110463-110463102.910102.91
10min1113764-113764105.985103.291.71107.17104.441.71
2109539-109539102.049103.18
3112263-112263104.587105.74
4109650-109650102.153103.28
5108839-108839101.397102.53
6111184-111184103.582104.73
15min1111768-111768104.126101.461.70106.49103.751.70
2108947-108947101.498103.76
3110367-110367102.821105.14
4107050-10705099.730101.99
5107878-107878100.502102.76
6107435-107435100.089102.38
20min1110543-110543102.985100.761.61106.51104.181.61
2107504-107504100.153103.54
3108627-108627101.200104.66
4106634-10663499.343102.72
5106041-10604198.790102.16
6109561-109561102.070105.48
30min1110990-110990103.40199.672.13108.07104.212.11
2105244-10524498.048102.55
3107534-107534100.181104.77
4105117-10511797.930102.41
5105399-10539998.192102.66
6107618-107618100.260104.80
45min1106994-10699499.67898.601.48105.49104.251.47
2105075-10507597.890103.48
3107276-10727699.941105.64
4103793-10379396.696102.26
5104540-10454097.392102.95
6107347-107347100.007105.66
60min1105749-10574998.51896.641.48105.44103.381.49
2103428-10342896.356103.04
3104288-10428897.157103.97
4101851-10185194.887101.53
5102172-10217295.186101.83
6104888-10488897.716104.48
90min1104873-10487397.70296.101.61105.72103.921.60
2102370-10237095.370103.12
3104445-10444597.304105.19
4101757-10175794.799102.49
5100991-10099194.086101.79
6104492-10449297.347105.20
极限1104170-10417097.04795.321.25106.15104.211.28
2101605-10160594.658103.47
3102805-10280595.776104.75
4100718-10071893.831102.58
5101483-10148394.544103.29
6103147-10314796.094105.03
左氨氯地平叶酸片项目信息
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5000
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%
117.34 1885461884661879431879511883201882450.16
217.421880801876581878690.16
单位质量响应值RSD%判断
10856.1110784.670.47数据可信
供试品溶液-24082901批-左氨氯地平-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%
5min1111612-111612104.204103.711.17104.20103.721.17
2111810-111810104.389104.39
3112680-112680105.201105.20
4111179-111179103.799103.80
5110233-110233102.916102.92
6109011-109011101.775101.78
10min1111171-111171103.792103.521.44104.95104.681.44
2112127-112127104.685105.84
3112913-112913105.418106.59
4110579-110579103.239104.39
5110123-110123102.814103.96
6108385-108385101.191102.32
15min1110178-110178102.865101.681.27105.18103.991.27
2109843-109843102.552104.88
3109876-109876102.583104.92
4108056-108056100.884103.18
5108930-108930101.700103.99
6106599-10659999.523101.78
20min1110020-110020102.717100.642.23106.17104.072.19
2109490-109490102.223105.69
3110355-110355103.030106.51
4106095-10609599.053102.47
5105354-10535498.361101.78
6105441-10544198.442101.80
30min1107855-107855100.69699.661.82105.29104.211.80
2107729-107729100.578105.18
3109485-109485102.218106.84
4105206-10520698.223102.74
5105871-10587198.844103.35
6104321-10432197.397101.85
45min1105372-10537298.37898.091.37104.09103.751.37
2105277-10527798.289104.01
3107206-107206100.090105.85
4104729-10472997.778103.39
5105056-10505698.083103.69
6102733-10273395.914101.45
60min1105454-10545498.45497.201.33105.26103.951.34
2104128-10412897.216104.02
3105736-10573698.718105.59
4103862-10386296.968103.67
5103559-10355996.685103.38
6101929-10192995.163101.77
90min1103323-10332396.46596.301.36104.37104.131.35
2103776-10377696.888104.78
3105446-10544698.447106.42
4101741-10174194.988102.77
5102819-10281995.994103.77
6101760-10176095.006102.67
极限1102080-10208095.30495.131.56104.28104.021.54
2102796-10279695.973104.94
3104367-10436797.440106.50
4101070-10107094.361103.19
5101220-10122094.501103.34
699800-9980093.176101.89
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