比索洛尔左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)1.5
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%
113.779730197485980989763298008977050.35
213.789807097979980240.07
单位质量响应值RSD%判断
7095.507113.500.18数据可信
加速6月-供试品溶液-8145795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%
5min184688-8468875.26374.333.6775.2674.333.67
286739-8673977.08577.09
383133-8313373.88173.88
486703-8670377.05377.05
581774-8177472.67372.67
678826-7882670.05370.05
10min1101998-10199890.64689.131.9890.7789.261.98
299702-9970288.60688.73
399742-9974288.64188.76
4101915-10191590.57290.70
5101561-10156190.25890.38
696848-9684886.06986.19
15min1106510-10651094.65693.231.4694.9393.501.45
2103566-10356692.04092.32
3104928-10492893.25093.52
4105665-10566593.90594.18
5106140-10614094.32794.60
6102639-10263991.21691.48
20min1109912-10991297.67995.391.6498.1195.821.63
2105748-10574893.97994.41
3107371-10737195.42195.85
4107569-10756995.59796.03
5108324-10832496.26896.70
6105072-10507293.37893.79
30min1112189-11218999.70397.171.79100.3097.761.79
2107052-10705295.13895.72
3110167-11016797.90698.49
4108789-10878996.68197.28
5110407-11040798.11998.71
6107441-10744195.48396.05
45min1112797-112797100.24398.031.68101.0198.781.67
2108535-10853596.45697.20
3111326-11132698.93699.68
4109140-10914096.99397.75
5111621-11162199.19899.95
6108430-10843096.36297.09
极限1113012-113012100.43498.051.56101.3698.961.56
2108319-10831996.26497.17
3111258-11125898.87699.79
4109690-10969097.48298.40
5110773-11077398.44599.36
6108913-10891396.79297.68
比索洛尔左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)1.5
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%
113.779788597880974319829397660978300.33
213.789841897754980860.48
单位质量响应值RSD%判断
7104.587118.000.14数据可信
长期6月-供试品溶液-8145795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%
5min191273-9127381.03781.681.4581.0481.681.44
293690-9369083.18383.18
393124-9312482.68182.68
490889-9088980.69680.70
590404-9040480.26680.27
692611-9261182.22582.23
10min1101046-10104689.71492.691.8489.8592.821.84
2104937-10493793.16993.31
3106846-10684694.86495.00
4104164-10416492.48392.62
5104144-10414492.46592.60
6105225-10522593.42593.56
15min1106304-10630494.38395.731.4394.6796.021.43
2107039-10703995.03595.33
3110181-11018197.82598.12
4109268-10926897.01497.30
5107381-10738195.33995.63
6106786-10678694.81195.10
20min1107262-10726295.23396.971.4195.6897.421.40
2108382-10838296.22896.68
3111531-11153199.02499.48
4110280-11028097.91398.36
5109472-10947297.19597.64
6108383-10838396.22996.68
30min1110099-11009997.75298.631.1998.3599.241.19
2109990-10999097.65598.27
3113305-113305100.599101.22
4111931-11193199.37999.99
5110994-11099498.54799.16
6110191-11019197.83498.44
45min1110877-11087798.44398.922.0099.2199.701.99
2109508-10950897.22798.00
3114189-114189101.383102.18
4113516-113516100.786101.57
5111876-11187699.330100.10
6108516-10851696.34797.12
极限1111582-11158299.06999.481.42100.00100.421.41
2110473-11047398.08499.02
3113837-113837101.071102.03
4113805-113805101.043101.99
5112355-11235599.755100.69
6110195-11019597.83798.77
比索洛尔左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)1.5
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%
113.779790997886981799742497980978760.29
213.789825898280982690.02
单位质量响应值RSD%判断
7107.927131.280.24数据可信
中间条件6月-供试品溶液-8145795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%
5min193927-9392783.29784.402.9983.3084.402.99
295594-9559484.77584.77
397531-9753186.49386.49
499106-9910687.88987.89
591300-9130080.96780.97
693553-9355382.96582.96
10min1104893-10489393.02194.741.3493.1694.881.34
2107071-10707194.95395.09
3108159-10815995.91896.06
4108633-10863396.33896.48
5105754-10575493.78593.92
6106483-10648394.43194.57
15min1106133-10613394.12197.171.9694.4197.461.96
2108426-10842696.15596.45
3110725-11072598.19398.50
4112159-11215999.46599.77
5110852-11085298.30698.60
6109117-10911796.76797.06
20min1108209-10820995.96298.811.7896.4199.271.78
2110321-11032197.83598.29
3112324-11232499.611100.08
4112852-112852100.080100.55
5113673-113673100.808101.26
6111128-11112898.55199.01
30min1109485-10948597.09499.531.6497.70100.151.64
2111851-11185199.19299.81
3113469-113469100.627101.26
4112813-112813100.045100.68
5114674-114674101.695102.32
6111078-11107898.50699.13
45min1108169-10816995.92799.182.1496.7099.972.13
2111627-11162798.99399.78
3113672-113672100.807101.61
4113222-113222100.408101.21
5114340-114340101.399102.19
6110008-11000897.55898.34
极限1109445-10944597.05899.251.7797.99100.201.77
2111780-11178099.129100.08
3113296-113296100.473101.44
4112621-11262199.875100.85
5114504-114504101.545102.51
6109837-10983797.40698.35
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