依折麦布瑞舒伐他汀钙片项目信息
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RSF-703-230318-D对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.9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0.96
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.754686984688134671264705944691224688710.27
210.814711744675794693760.55
单位质量响应值RSD%判断
43615.9143420.540.32数据可信
长期9月-供试品溶液-瑞舒伐他汀钙-pH7.0
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024030121148783148720348751795.7396.302.0194.28%～98.33%
250011950256550134298.44
347576547737047656893.58
448218248260448239394.72
549379650055149717497.62
649809449749949779697.74
2024030221150160849728949944898.0796.961.7495.19%～98.72%
249422649450149436497.07
348550248653348601895.43
450797850751850774899.70
548732948813548773295.77
648548048929648738895.70
20240303211515740518598517169101.5599.342.5896.65%～102.02%
249967349714049840697.86
3514175517019515597101.24
450974850868150921499.99
548198048401048299594.84
6512579511498512038100.54
依折麦布瑞舒伐他汀钙片项目信息
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ZT-705-231101-1-D对照品来源中检院对照品使用方法直接使用
对照品含量(%)100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1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.674213224216614232454229144210534220390.24
210.694198084204284201180.11
单位质量响应值RSD%判断
39553.8039300.090.46数据可信
长期9月-供试品溶液-依折麦布-pH7.0
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024030121142790542323242556897.1595.881.6494.24%～97.52%
242043141968742005995.89
341367441828441597994.96
442929142758042843697.80
541654242490042072196.04
640956840892940924893.42
2024030221142914942898442906697.9495.772.5993.17%～98.36%
243067842882642975298.10
341505841105641305794.29
439740640497040118891.58
542383642159442271596.49
642104342193842149096.21
2024030321143276943789743533399.3796.811.8594.94%～98.69%
242437341816042126696.16
341274441174941224694.10
442775043111542943298.03
542540442209242374896.73
642339742203042271496.49
依折麦布瑞舒伐他汀钙片项目信息
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RSF-703-230318-D对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.9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0.96
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.754675284649414672754680994692314674150.34
210.814658794660474659630.03
单位质量响应值RSD%判断
43480.4743104.810.62数据可信
中间条件9月-供试品溶液-瑞舒伐他汀钙-pH7.0
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024030121149574049687049630597.9698.481.7896.65%～100.31%
249308048971449139796.99
349274749099349187097.09
4514900512601513750101.40
549489649505049497397.70
650530350557350543899.76
2024030221147912347801047856694.4695.323.3391.99%～98.65%
249911049897549904298.50
347672847678647675794.10
449989150005149997198.68
548801248461848631595.99
645716245683245699790.20
2024030321150342550456350399499.4898.721.1197.58%～99.87%
2507646506606507126100.10
350170450138550154498.99
449953549898149925898.54
549119649118049118896.95
649769849820349795098.29
依折麦布瑞舒伐他汀钙片项目信息
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ZT-705-231101-1-D对照品来源中检院对照品使用方法直接使用
对照品含量(%)100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1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.674194344210194220594177764217784204130.43
210.694184054176864180460.13
单位质量响应值RSD%判断
39401.4139106.270.54数据可信
中间条件9月-供试品溶液-依折麦布-pH7.0
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024030121143343243044143193699.0396.813.0893.68%～99.94%
239887839890139889091.46
343033542861542947598.47
442788042778942783498.09
543076743024943050898.71
641589341375041482295.11
2024030221142032442155642094096.5197.331.6595.65%～99.01%
243271743342543307199.29
341678741621341650095.50
441599241965041782195.80
543227842883143055498.72
642870842750742810898.16
2024030321140210940330740270892.3395.753.2092.54%～98.96%
243337243121443229399.12
342085342231542158496.66
442786042764542775298.08
542223342069442146496.63
639921340052739987091.68
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