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%
113.616492664961649446492164728648960.15
213.626463664941647880.34
单位质量响应值RSD%判断
4768.264756.830.17数据可信
中间条件24月-供试品溶液-2023022521批-pH4.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min160054-6005481.75474.389.4981.7574.389.49
257445-5744578.20278.20
357567-5756778.36878.37
445402-4540261.80761.81
554555-5455574.26874.27
652824-5282471.91171.91
10min168948-6894893.86190.553.5794.0090.673.57
267518-6751891.91592.04
366635-6663590.71390.84
464638-6463887.99488.10
568527-6852793.28893.41
662830-6283085.53385.65
15min170600-7060096.11093.901.9096.4094.181.91
268855-6885593.73594.02
368255-6825592.91893.20
468357-6835793.05793.31
570478-7047895.94496.22
667314-6731491.63791.90
20min171568-7156897.42893.872.8697.8894.302.85
267417-6741791.77792.22
366033-6603389.89390.33
470100-7010095.43095.83
569533-6953394.65895.10
669058-6905894.01194.43
30min171908-7190897.89195.551.8898.5196.141.88
270857-7085796.46097.05
367983-6798392.54893.13
470609-7060996.12396.69
569827-6982795.05895.65
669951-6995195.22795.80
45min171958-7195897.95995.103.0798.7495.843.05
271211-7121196.94297.70
365799-6579989.57590.32
469890-6989095.14495.87
570218-7021895.59096.35
670049-7004995.36096.09
60min172316-7231698.44695.762.5699.3996.662.55
270617-7061796.13397.05
367914-6791492.45493.34
469059-6905994.01294.90
569724-6972494.91895.83
672409-7240998.57399.46
极限169839-6983995.07495.211.9696.1896.281.95
271293-7129397.05498.13
368389-6838993.10094.14
468379-6837993.08794.13
570177-7017795.53496.61
671559-7155997.41698.47
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%
113.616469965042652396527565114650740.36
213.626519965241652200.05
单位质量响应值RSD%判断
4781.344788.550.11数据可信
中间条件24月-供试品溶液-2023022721批-pH4.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min154259-5425973.51973.2713.3073.5273.2713.30
249668-4966867.29867.30
342248-4224857.24457.24
456820-5682076.98976.99
561923-6192383.90383.90
659541-5954180.67680.68
10min167798-6779891.86490.685.5191.9990.805.52
267494-6749491.45291.56
360943-6094382.57582.67
464427-6442787.29687.42
570442-7044295.44695.59
670438-7043895.44195.58
15min169303-6930393.90394.293.9494.1894.563.94
271890-7189097.40897.67
365029-6502988.11288.34
468137-6813792.32392.60
570842-7084295.98896.29
672342-7234298.02198.31
20min169424-6942494.06795.392.3094.5095.822.31
272941-7294198.83299.26
368342-6834292.60192.98
469725-6972594.47594.90
570595-7059595.65496.11
671359-7135996.68997.15
30min169865-6986594.66496.212.2995.2596.802.30
272653-7265398.44299.03
368884-6888493.33593.87
470758-7075895.87496.46
570748-7074895.86196.48
673131-7313199.09099.71
45min169865-6986594.66497.161.9695.4197.911.96
273481-7348199.564100.32
370576-7057695.62896.32
471330-7133096.64997.39
571971-7197197.51898.30
673031-7303198.95499.74
60min170734-7073495.84297.050.9296.7597.960.93
272397-7239798.09599.02
371631-7163197.05797.91
471076-7107696.30597.21
571619-7161997.04197.98
672306-7230697.97298.92
极限170546-7054695.58797.101.5096.6598.171.50
273231-7323199.225100.31
370591-7059195.64896.66
472557-7255798.31299.38
571464-7146496.83197.93
671573-7157396.97998.09
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%
113.616535565576656966578765929656690.34
213.626545465483654680.04
单位质量响应值RSD%判断
4825.064806.750.27数据可信
中间条件24月-供试品溶液-2023022821批-pH4.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min149253-4925366.30779.029.2366.3179.029.23
260474-6047481.41381.41
365288-6528887.89487.89
460331-6033181.22181.22
560429-6042981.35381.35
656411-5641175.94475.94
10min168064-6806491.63194.022.6591.7494.152.66
270030-7003094.27894.41
371330-7133096.02896.17
470743-7074395.23895.37
571727-7172796.56396.70
667139-6713990.38690.51
15min172019-7201996.95696.631.8397.2296.921.83
271839-7183996.71497.01
373222-7322298.57598.88
470931-7093195.49195.79
572968-7296898.23398.53
669700-6970093.83494.11
20min171791-7179196.64996.801.8597.0797.251.86
271410-7141096.13696.59
373500-7350098.95099.42
471052-7105295.65496.11
573456-7345698.89099.35
670201-7020194.50894.94
30min172515-7251597.62496.841.4398.2197.451.43
271377-7137796.09296.71
373170-7317098.50599.14
471164-7116495.80596.42
572757-7275797.94998.57
670595-7059595.03995.63
45min172317-7231797.35797.111.4298.1197.881.42
272421-7242197.49798.27
371672-7167296.48997.29
471585-7158596.37297.14
573893-7389399.479100.27
670920-7092095.47696.23
60min172146-7214697.12796.691.1398.0497.621.13
272191-7219197.18798.12
372838-7283898.05899.02
471159-7115995.79896.73
571991-7199196.91897.87
670589-7058995.03195.94
极限172453-7245397.54096.471.7798.6197.561.76
272311-7231197.34998.45
372287-7228797.31798.44
470227-7022794.54395.64
572784-7278497.98699.10
669873-6987394.06795.13
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