培哚普利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DJ468-220103对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)10供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.254121841084415204108041213412230.44
210.234157341625415990.09
单位质量响应值RSD%判断
4021.764066.370.79数据可信
长期26月-供试品溶液-培哚普利-pH2.0
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
20240301211488174882948823103.01102.422.03100.24%～104.60%
2494954956149528104.50
3489414900548973103.32
4493174924949283103.98
547127470934711099.39
6475704752847549100.32
2024030221147163473044723499.66101.641.48100.06%～103.22%
2480784804848063101.40
3493074909749202103.81
4475234769047606100.44
5486584870748682102.71
6482614826548263101.83
20240303211476144789347754100.75102.540.94101.54%～103.54%
2490824892149002103.39
3488314876048796102.95
4483334859848466102.25
5488334890248868103.10
6488044862348714102.78
培哚普利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)10供试品稀释倍数2系数0.721
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.751610681606001601461628561617631612870.66
213.781597941595351596640.12
单位质量响应值RSD%判断
11729.9611586.650.87数据可信
长期26月-供试品溶液-氨氯地平-pH2.0
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
20240301211180825180912180868100.57100.841.8498.90%～102.78%
2182725182662182694101.59
3182311182561182436101.45
4186383186591186487103.70
517740617755417748098.69
617831917785617808899.03
2024030221117594517579217586897.79100.581.8298.67%～102.50%
217856017863917860099.31
3184321184077184199102.43
4180677180761180719100.49
5184288184311184300102.48
6181629181649181639101.00
20240303211180032180332180182100.19101.641.24100.32%～102.96%
2186850186443186646103.79
3183537183584183560102.07
4182676182545182610101.54
5182558182936182747101.62
6180972181005180988100.64
培哚普利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DJ468-220103对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)10供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.254170541599416374180341770417030.21
210.234165441645416500.02
单位质量响应值RSD%判断
4068.594071.360.05数据可信
长期26月-供试品溶液-培哚普利-pH2.0
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024030121147348474504739999.36100.041.5298.44%～101.63%
246766466614671497.93
3484164828448350101.36
447566475864757699.73
5488064867548740102.18
647545475244753499.65
20240302211487184846548592101.86101.651.19100.39%～102.91%
2476814776447722100.04
3485664870848637101.96
4487574869148724102.14
5480324786847950100.52
6493274929549311103.37
20240303211481974808748142100.92101.571.29100.20%～102.93%
2493184918649252103.25
3486394868548662102.01
4477934777247782100.17
5478504783247841100.29
6490744897249023102.77
培哚普利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)10供试品稀释倍数2系数0.721
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.758165081810812408158381814816190.29
213.788045180536804940.08
单位质量响应值RSD%判断
5935.935841.361.14数据可信
长期26月-供试品溶液-氨氯地平-pH2.0
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024030121189643893558949998.5398.980.8598.10%～99.86%
289112887978895497.93
390874906819077899.94
489449893228938698.41
590846907329078999.95
689886901629002499.11
2024030221189234894118932298.3499.691.9097.71%～101.68%
288114882128816397.06
390062899609001199.09
4927559291092832102.20
5912539102791140100.34
6919429177791860101.13
2024030321189981902179009999.19101.071.4599.54%～102.61%
2927579277692766102.13
3918889184891868101.14
4914689166691567100.81
590944906049077499.93
6937349380493769103.23
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