阿齐沙坦左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100546-202105 对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数3125
标示量(mg)5供试品稀释倍数2系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.451023901022801022861020711026081023270.20
212.431020111020441020280.03
单位质量响应值RSD%判断
8219.048208.210.10数据可信
供试品溶液-8145761批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min148319-4831947.54350.877.0547.5450.877.05
255947-5594755.04855.05
351858-5185851.02551.02
453174-5317452.32052.32
554417-5441753.54353.54
646481-4648145.73445.73
10min174081-7408172.89175.703.8973.1575.993.90
281527-8152780.21780.52
376838-7683875.60475.89
478022-7802276.76977.06
577884-7788476.63376.93
673289-7328972.11272.37
15min181120-8112079.81780.563.7780.4981.263.78
286294-8629484.90885.66
380702-8070279.40580.11
483467-8346782.12682.84
582586-8258681.25981.98
677087-7708775.84976.50
20min183640-8364082.29684.264.0683.4185.424.06
289824-8982488.38189.60
387253-8725385.85187.00
487914-8791486.50287.68
585093-8509383.72684.90
680110-8011078.82379.90
30min187745-8774586.33588.763.3387.9190.383.33
291175-9117589.71091.42
393014-9301491.52093.14
492896-9289691.40493.06
590934-9093489.47391.11
685477-8547784.10485.62
45min188173-8817386.75689.933.6188.8192.043.58
290004-9000488.55890.77
394645-9464593.12495.25
494613-9461393.09395.25
593609-9360992.10594.24
687372-8737285.96887.95
60min192161-9216190.68092.712.9193.2195.322.91
293316-9331691.81794.52
396908-9690895.35198.00
496558-9655895.00797.69
596175-9617594.63097.28
690220-9022088.77191.23
极限194377-9437792.86193.441.7095.9096.571.74
294896-9489693.37196.59
396421-9642194.87298.05
495634-9563494.09897.30
596355-9635594.80797.98
692115-9211590.63593.59
阿齐沙坦左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100546-202105 对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数3125
标示量(mg)5供试品稀释倍数2系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.451019991019951019201021901017221019650.17
212.431031741025341028540.44
单位质量响应值RSD%判断
8189.968274.660.73数据可信
供试品溶液-8145761批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min147531-4753146.66248.738.0146.6648.738.01
253165-5316552.19352.19
353220-5322052.24752.25
453112-5311252.14152.14
546192-4619245.34845.35
644611-4461143.79643.80
10min173492-7349272.14974.095.1772.4174.365.17
275059-7505973.68773.98
379859-7985978.40078.69
480570-8057079.09879.39
572708-7270871.37971.63
671124-7112469.82470.07
15min179081-7908177.63680.564.2878.3081.244.29
282069-8206980.56981.27
385296-8529683.73784.46
487208-8720885.61486.34
578669-7866977.23177.88
680014-8001478.55279.18
20min183435-8343581.91083.804.5583.0084.934.56
286598-8659885.01686.16
389219-8921987.58988.78
490180-9018088.53289.74
581143-8114379.66080.74
681586-8158680.09581.16
30min187898-8789886.29288.072.8487.8489.662.88
289563-8956387.92689.55
391913-9191390.23391.91
493605-9360591.89493.59
588116-8811686.50688.03
687147-8714785.55487.07
45min187961-8796186.35488.591.9088.3890.671.95
291155-9115589.48991.60
391949-9194990.26992.45
492047-9204790.36592.57
589251-8925187.62089.62
689048-8904887.42189.41
60min191920-9192090.24091.141.6092.7593.721.62
294238-9423892.51695.12
392617-9261790.92593.60
494344-9434492.62095.33
590492-9049288.83891.33
693398-9339891.69194.16
极限192263-9226390.57791.891.9993.5894.972.01
294458-9445892.73295.85
393982-9398292.26595.45
496125-9612594.36897.59
590774-9077489.11592.10
694005-9400592.28795.27
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