坎地沙坦酯片项目信息
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100685-201903对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)8供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.987718577553775407731877418774030.21
216.077758177691776360.11
单位质量响应值RSD%判断
4843.744831.110.19数据可信
供试品溶液-24122001批-pH6.8(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min116843-1684319.54611.9736.4119.5511.9736.42
210771-1077112.50012.50
311440-1144013.27613.28
49028-902810.47710.48
56026-60266.9936.99
67786-77869.0369.04
10min131195-3119536.20131.6216.9936.2331.6416.99
229986-2998634.79834.82
331078-3107836.06636.09
427788-2778832.24832.27
519720-1972022.88522.90
623727-2372727.53527.55
15min148327-4832756.08351.9511.3656.1852.0211.37
248199-4819955.93456.01
348894-4889456.74156.82
446054-4605453.44553.52
536459-3645942.31042.36
640639-4063947.16147.22
20min161475-6147571.34167.406.9571.5367.566.97
260284-6028469.95970.13
360831-6083170.59370.77
459405-5940568.93969.10
551146-5114659.35459.47
655340-5534064.22164.36
30min175959-7595988.14984.723.4788.4584.993.49
274009-7400985.88686.17
374267-7426786.18686.48
473284-7328485.04585.32
568607-6860779.61779.84
671878-7187883.41383.66
45min184619-8461998.19995.272.0798.6595.682.09
282864-8286496.16296.59
382479-8247995.71696.15
480728-8072893.68494.10
579771-7977192.57392.92
682094-8209495.26995.65
60min188447-88447102.64198.412.39103.2698.982.41
285457-8545799.17299.76
384783-8478398.38998.99
483390-8339096.77397.35
582820-8282096.11196.62
683910-8391097.37697.92
极限188620-88620102.84298.732.45103.6399.462.47
286081-8608199.896100.65
384525-8452598.09098.85
483141-8314196.48497.22
583061-8306196.39197.06
685016-8501698.66099.37
坎地沙坦酯片项目信息
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100685-201903对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)8供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.987797077946779037772977793778680.14
216.077789377700777960.18
单位质量响应值RSD%判断
4872.844841.070.47数据可信
供试品溶液-24122401批-pH6.8(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min17345-73458.4907.9912.298.497.9912.27
26224-62247.1947.19
36124-61247.0787.08
47935-79359.1729.17
56124-61247.0787.08
67720-77208.9238.92
10min124776-2477628.63725.5010.7128.6525.5210.70
220922-2092224.18224.19
320057-2005723.18223.19
424687-2468728.53428.55
519254-1925422.25422.27
622701-2270126.23826.25
15min142473-4247349.09244.989.6149.1545.039.60
237067-3706742.84342.90
336099-3609941.72441.77
443274-4327450.01750.08
534009-3400939.30939.36
640562-4056246.88346.94
20min156635-5663565.46061.886.7965.6062.016.79
251645-5164559.69359.82
351956-5195660.05260.17
457309-5730966.23966.39
547954-4795455.42755.54
655731-5573164.41664.55
30min171382-7138282.50581.442.6382.7681.672.64
269571-6957180.41280.64
369672-6967280.52980.75
472405-7240583.68883.94
567579-6757978.11078.32
672130-7213083.37083.61
45min179956-7995692.41593.201.0192.8193.581.01
281485-8148594.18394.54
379852-7985292.29592.65
481472-8147294.16894.56
579917-7991792.37092.71
681147-8114793.79294.18
60min182326-8232695.15596.470.7595.7097.000.73
284185-8418597.30397.82
383416-8341696.41596.92
483723-8372396.76997.32
583535-8353596.55297.04
683610-8361096.63997.18
极限183000-8300095.93497.070.6296.6497.760.61
284470-8447097.63398.31
384246-8424697.37498.04
484122-8412297.23197.94
583861-8386196.92997.58
684204-8420497.32598.03
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