坎地沙坦酯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)5供试品稀释倍数1系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.616479564828645646462864689647010.18
213.626484065110649750.30
单位质量响应值RSD%判断
4753.934770.560.25数据可信
中间条件24月-供试品溶液-2023022521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%
5min165479-6547989.14575.5913.0689.1475.5813.06
253087-5308772.27472.27
362423-6242384.98484.98
455673-5567375.79575.79
549585-4958567.50667.51
646876-4687663.81863.82
10min172186-7218698.27695.683.0398.4295.803.04
270758-7075896.33296.45
371439-7143997.25997.40
471782-7178297.72697.85
568826-6882693.70193.81
666673-6667390.77090.88
15min171995-7199598.01697.251.1598.3397.531.16
271997-7199798.01898.30
370757-7075796.33096.63
472299-7229998.43098.72
571333-7133397.11497.38
670201-7020195.57395.83
20min171984-7198498.00197.780.7198.4898.230.70
271949-7194997.95398.40
370864-7086496.47696.94
472327-7232798.46898.92
572064-7206498.11098.54
671743-7174397.67398.09
30min171004-7100496.66697.250.5297.3197.860.51
271443-7144397.26497.87
371082-7108296.77397.40
471992-7199298.01298.63
571680-7168097.58798.18
671375-7137597.17297.75
45min171129-7112996.83796.720.5497.6497.500.52
270906-7090696.53397.30
370407-7040795.85496.64
471406-7140697.21497.99
571003-7100396.66597.42
671425-7142597.24097.98
60min170988-7098896.64596.590.8797.6197.520.86
270212-7021295.58896.52
370236-7023695.62196.57
471672-7167297.57698.52
571495-7149597.33598.25
671084-7108496.77597.68
极限170696-7069696.24796.120.8997.3797.210.88
270500-7050095.98097.07
369448-6944894.54895.65
471300-7130097.06998.17
570837-7083796.43997.52
670834-7083496.43597.50
坎地沙坦酯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)5供试品稀释倍数1系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.616450864683644486481364468645840.25
213.626493765032649840.11
单位质量响应值RSD%判断
4745.334771.220.39数据可信
中间条件24月-供试品溶液-2023022721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%
5min161293-6129383.51683.368.6983.5283.368.69
264884-6488488.40988.41
357479-5747978.31978.32
452647-5264771.73571.73
567068-6706891.38491.38
663690-6369086.78286.78
10min172126-7212698.27698.332.1198.4298.472.12
272217-7221798.40098.55
372540-7254098.84098.97
469773-6977395.07095.19
574516-74516101.533101.69
671815-7181597.85398.00
15min171332-7133297.19498.621.7297.5098.931.72
272287-7228798.49698.81
372331-7233198.55698.85
472143-7214398.29998.58
574749-74749101.850102.17
671440-7144097.34297.65
20min171714-7171497.71598.581.1398.1899.051.13
272053-7205398.17798.65
372677-7267799.02799.49
472126-7212698.27698.72
573835-73835100.605101.10
671696-7169697.69098.16
30min171751-7175197.76598.421.4198.3999.051.41
271855-7185597.90798.55
372105-7210598.24898.87
472289-7228998.49899.10
574165-74165101.055101.71
671230-7123097.05597.69
45min170843-7084396.52897.901.5797.3298.701.57
271869-7186997.92698.73
371795-7179597.82598.61
471326-7132697.18697.96
574009-74009100.842101.67
671271-7127197.11197.91
60min171205-7120597.02197.581.1997.9798.541.20
271256-7125697.09198.06
371467-7146797.37898.33
471702-7170297.69998.63
573248-7324899.805100.80
670820-7082096.49797.45
极限170870-7087096.56597.101.2597.6898.221.25
270569-7056996.15597.28
371156-7115696.95598.07
471490-7149097.41098.50
572928-7292899.369100.53
670583-7058396.17497.29
坎地沙坦酯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)5供试品稀释倍数1系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.616435064332645816451864426644410.17
213.626435364663645080.34
单位质量响应值RSD%判断
4734.834736.270.03数据可信
中间条件24月-供试品溶液-2023022821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%
5min164806-6480688.72587.386.5988.7387.386.59
267278-6727892.11092.11
364756-6475688.65788.66
464323-6432388.06488.06
555539-5553976.03876.04
666228-6622890.67290.67
10min171007-7100797.21597.723.2097.3697.873.20
272715-7271599.55499.71
372439-7243999.17699.32
470943-7094397.12897.27
567307-6730792.15092.28
673856-73856101.116101.27
15min171166-7116697.43398.981.3197.7499.281.32
272445-7244599.18499.50
372551-7255199.32999.64
471475-7147597.85698.16
572263-7226398.93599.22
673859-73859101.120101.44
20min171397-7139797.74998.941.5398.2299.421.53
272640-7264099.45199.94
372560-7256099.34199.82
470850-7085097.00097.47
572144-7214498.77299.22
674024-74024101.346101.83
30min170711-7071196.81098.451.3897.4599.091.38
272342-7234299.04399.69
372411-7241199.13799.78
470990-7099097.19297.83
571641-7164198.08398.69
673361-73361100.438101.10
45min170833-7083396.97798.151.1697.7798.961.16
271976-7197698.54299.36
372166-7216698.80299.61
470690-7069096.78197.58
571630-7163098.06898.84
672854-7285499.744100.57
60min170222-7022296.14197.751.3897.1098.721.38
271804-7180498.30699.29
371460-7146097.83598.81
470498-7049896.51897.48
571431-7143197.79698.73
672968-7296899.900100.89
极限169844-6984495.62397.291.4596.7498.421.45
271448-7144897.81998.96
371328-7132897.65598.79
469958-6995895.77996.90
571190-7119097.46698.57
672599-7259999.395100.55
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