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%
19.834046940576405874060740618405710.15
29.894062240587406040.07
单位质量响应值RSD%判断
4127.264105.560.38数据可信
长期9月-供试品溶液-2022081401批-培哚普利-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%
5min148862-48862101.27698.112.88101.2898.112.88
247494-4749498.44098.44
344987-4498793.24493.24
448466-48466100.455100.46
547078-4707897.57897.58
647129-4712997.68497.68
10min148235-4823599.976100.100.90101.10101.190.90
248035-4803599.562100.66
348156-4815699.813100.85
448898-48898101.351102.47
547737-4773798.944100.03
648697-48697100.934102.02
15min147297-4729798.03298.870.86100.27101.080.86
247609-4760998.679100.88
347270-4727097.976100.12
448341-48341100.196102.44
547761-4776198.994101.18
647940-4794099.365101.57
20min146936-4693697.28498.351.24100.61101.651.20
248004-4800499.498102.79
347746-4774698.963102.20
448147-4814799.794103.15
547066-4706697.553100.84
646805-4680597.012100.32
30min147436-4743698.32096.461.25102.73100.861.21
245874-4587495.08399.48
346462-4646296.301100.63
446854-4685497.114101.58
545982-4598295.30799.67
646633-4663396.656101.04
45min145715-4571594.75395.521.45100.25100.981.40
245670-4567094.660100.12
346259-4625995.881101.28
446906-4690697.222102.77
545206-4520693.69899.12
646752-4675296.903102.37
极限145220-4522093.72798.8512.62100.28105.3811.81
244658-4465892.56299.07
359939-59939124.235130.70
445972-4597295.286101.91
545169-4516993.621100.09
645198-4519893.682100.22
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4000
标示量(mg)5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%
114.088304783065830208321383127830940.10
214.088351783646835820.11
单位质量响应值RSD%判断
5901.565936.220.42数据可信
长期9月-供试品溶液-2022081401批-氨氯地平-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%
5min187010-8701095.29693.132.2395.3093.132.23
283837-8383791.82191.82
382046-8204689.85989.86
486900-8690095.17695.18
585080-8508093.18293.18
685332-8533293.45893.46
10min188174-8817496.57195.881.3997.6396.911.39
285520-8552093.66494.68
387915-8791596.28797.29
488785-8878597.24098.30
586657-8665794.91095.94
688194-8819496.59397.63
15min185452-8545293.59095.481.4995.7297.581.45
289037-8903797.51699.58
386237-8623794.45096.52
488156-8815696.55198.69
587300-8730095.61497.70
686893-8689395.16897.28
20min185403-8540393.53694.301.1296.7197.461.09
285565-8556593.71496.86
386905-8690595.18198.30
487468-8746895.79899.01
586262-8626294.47797.63
684977-8497793.07096.24
30min186530-8653094.77192.671.7698.9896.881.70
282076-8207689.89294.08
384853-8485392.93497.11
485422-8542293.55797.83
584135-8413592.14796.35
684640-8464092.70196.90
45min183548-8354891.50591.761.7596.7796.991.69
281579-8157989.34894.53
384767-8476792.84098.05
485514-8551493.65898.97
582684-8268490.55895.78
684569-8456992.62397.86
极限182740-8274090.62090.091.8296.9096.351.75
279566-7956687.14393.32
383473-8347391.42297.66
483696-8369691.66798.02
582028-8202889.84096.07
682059-8205989.87496.14
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