盐酸伐地那非片项目信息
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D23106010771对照品来源中检所对照品使用方法直接使用
对照品含量(%)90.12对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数0.9306
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.554065024059554058524057554046864057500.17
212.544024334042464033400.32
单位质量响应值RSD%判断
32330.6832164.270.37数据可信
加速6月-供试品溶液-pH1.0
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024030121141628241698641663497.5296.563.0193.52%~99.61%
241886741817441852097.96
340001139670739835993.24
439632139516839574492.63
542080142083542081898.50
642529942525242527699.54
2024030221140024240028640026493.6993.603.7589.92%~97.28%
239883239930339906893.41
338412038391338401689.88
4427944427680427812100.14
539736939748739742893.02
639093839061539077691.47
2024030321140971540966440969095.8994.324.0390.33%~98.30%
241574041535941555097.27
339503639870439687092.89
440820340796740808595.52
541476141460841468497.06
637305737256537281187.26
盐酸伐地那非片项目信息
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D23106010771对照品来源中检所对照品使用方法直接使用
对照品含量(%)90.12对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数0.9306
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.554027804053624051434054844053494048240.29
212.544038704049864044280.20
单位质量响应值RSD%判断
32256.8932251.040.02数据可信
长期6月-供试品溶液-pH1.0
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024030121141438041833541635897.4397.332.1495.14%~99.51%
242203742243742223798.81
341256541267841262296.56
440177339990340083893.80
542692742648642670699.86
641670041655441662797.50
2024030221141472641606441539597.2196.102.3193.77%~98.42%
241715541501441608497.37
339491839500039495992.43
440283040286640284894.27
541682241672141677297.53
641769741791541780697.77
2024030321142581242592542586899.6695.374.8190.56%~100.18%
241856441854641855597.95
341945041878041911598.08
441374041544641459397.02
537644137476737560487.90
639080039213639146891.61
盐酸伐地那非片项目信息
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D23106010771对照品来源中检所对照品使用方法直接使用
对照品含量(%)90.12对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数0.9306
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.554008614062794071904073084070954057470.69
212.544005244032774019000.49
单位质量响应值RSD%判断
32330.4432049.440.62数据可信
中间条件6月-供试品溶液-pH1.0
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024030121139835939820339828193.3993.764.0789.77%~97.76%
239823139839639831493.40
339554739439939497392.62
442420542537342478999.61
540709140814040761695.58
637515937525637520887.98
2024030221139854539863039858893.4694.072.2391.87%~96.27%
241098941042541070796.30
339296439278639287592.12
438987138953138970191.38
540491440436540464094.88
641090241028941059696.28
2024030321140718940736140727595.5094.281.5392.77%~95.79%
240425040367340396294.72
340999341045241022296.19
439731339392739562092.77
539517139535939526592.68
640011640009440010593.82
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