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4000
标示量(mg)5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%
19.951926019423192051924619498193260.66
29.981948719533195100.17
单位质量响应值RSD%判断
1942.311954.910.46数据可信
长期12月-供试品溶液-2022082101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%
5min122105-2210596.78898.052.0496.7998.052.04
222087-2208796.70996.71
321905-2190595.91295.91
422444-2244498.27298.27
523119-23119101.228101.23
622701-2270199.39799.40
10min122441-2244198.259100.032.0999.33101.122.08
222591-2259198.91699.99
322865-22865100.116101.18
422933-22933100.413101.51
523731-23731103.907105.03
622506-2250698.54499.65
15min122649-2264999.17098.861.09101.34101.061.08
222147-2214796.97299.15
322686-2268699.332101.51
422778-2277899.735101.94
522773-2277399.713101.99
622442-2244298.263100.46
20min121760-2176095.27798.091.9198.55101.391.87
222372-2237297.957101.21
322916-22916100.339103.62
422756-2275699.638102.95
522526-2252698.631102.02
622090-2209096.722100.01
30min121671-2167194.88896.242.8599.22100.632.75
222129-2212996.893101.23
321073-2107392.26996.67
422747-2274799.599104.02
522565-2256598.802103.29
621688-2168894.96299.33
45min121578-2157894.48096.001.2499.86101.461.22
221796-2179695.435100.85
322194-2219497.178102.60
422249-2224997.418102.95
522018-2201896.407101.99
621718-2171895.093100.51
极限121331-2133193.39994.462.4299.83100.982.30
221403-2140393.714100.19
321986-2198696.267102.77
420963-2096391.78898.40
522398-2239898.071104.72
621354-2135493.50099.98
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%
113.958055680558806168064880750806260.10
214.018024880618804330.33
单位质量响应值RSD%判断
5779.645741.110.48数据可信
长期12月-供试品溶液-2022082101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%
5min181296-8129691.48892.852.2291.4992.842.22
281744-8174491.99391.99
380416-8041690.49890.50
482220-8222092.52892.53
585309-8530996.00596.00
684027-8402794.56294.56
10min183109-8310993.52994.941.7694.5595.971.75
284453-8445395.04196.06
384762-8476295.38996.39
484059-8405994.59895.63
586962-8696297.86598.93
682818-8281893.20194.25
15min183617-8361794.10094.371.0496.1696.461.04
283042-8304293.45395.53
384081-8408194.62396.69
484508-8450895.10397.18
585075-8507595.74197.90
682805-8280593.18795.27
20min181252-8125291.43993.181.4794.5496.311.43
282586-8258692.94096.06
384618-8461895.22798.34
483570-8357094.04897.18
582975-8297593.37896.60
681785-8178592.03995.16
30min180501-8050190.59492.251.4994.7196.421.48
281639-8163991.87496.02
381643-8164391.87996.05
482967-8296793.36997.55
583846-8384694.35898.61
681218-8121891.40195.55
45min179514-7951489.48391.191.1994.6196.381.16
281325-8132591.52196.69
381530-8153091.75296.95
482233-8223392.54397.76
581213-8121391.39596.70
680349-8034990.42395.58
极限178988-7898888.89190.482.0495.0196.691.98
279881-7988189.89696.08
381293-8129391.48597.70
481077-8107791.24297.49
582790-8279093.17099.49
678363-7836388.18894.35
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