依折麦布阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DJ333-221017对照品来源自制对照品使用方法直接使用
对照品含量(%)99.67对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.151830631830811830681830441828051830120.07
211.221827711830291829000.10
单位质量响应值RSD%判断
16413.6316301.250.49数据可信
稳定性考察-加速1月-供试品溶液-依折麦布-pH6.8(内含0.2%Tween80)
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024011221批118153818172818163399.61100.881.7699.02%～102.74%
218122618116418119599.37
3185932185801185866101.93
4188662188539188600103.43
5185699185728185714101.85
618064418066218065399.07
2024011222批1187049187025187037102.57100.342.2098.04%～102.65%
2182470182565182518100.09
318016518023818020298.82
4185772185794185783101.88
517666317653617660096.85
6185638185797185718101.85
2024011223批117688017681217684696.98100.802.5798.08%～103.52%
218221718167418194699.78
318126518127718127199.41
4188319188688188504103.38
5185046185050185048101.48
6189187189267189227103.77
依折麦布阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100590-202005对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.9对照品水分(%)0对照品稀释倍数2500
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.191603921604521603091602831602841603440.05
211.061601961601081601520.04
单位质量响应值RSD%判断
14329.2214480.290.75数据可信
稳定性考察-加速1月-供试品溶液-阿托伐他汀钙-pH6.8(内含0.2%Tween80)
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024011221批1169584169622169603201.13205.791.98201.52%～210.06%
2174489174665174577207.03
3169133168982169058200.48
4176117176069176093208.83
5177353177386177370210.34
6174535174439174487206.92
2024011222批1165745165655165700196.50199.473.61191.93%～207.02%
2169219169282169250200.71
3175254175115175184207.75
4174260174519174390206.81
5165531165611165571196.35
6159110159153159132188.71
2024011223批1167975167935167955199.18169.5149.0782.21%～256.80%
2169794169053169424200.92
3-00.00
4178078178707178392211.55
5173182173086173134205.32
6168704168708168706200.07
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