奥司他韦干糖浆项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号101096-202103对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数500
标示量(mg)75供试品稀释倍数5系数0.7612
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.313103063103133107083101213100313102960.09
210.343100473106033103250.13
单位质量响应值RSD%判断
30096.6130012.090.20数据可信
影响因素5天-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
2024051721批132251632225532238697.69100.242.0798.06%～102.41%
232920032909732914899.74
3331378331257331318100.40
432838532819932829299.48
5343159343287343223104.00
6330453330232330342100.10
2024051721批1337798338121337960102.4199.184.8994.09%～104.27%
2331286331428331357100.41
3331403331207331305100.39
4341411340436340924103.31
529669829640529655289.86
632565532592032578898.72
l批1333260333163333212100.97102.911.61101.17%～104.64%
2342844342887342866103.89
3346401346443346422104.97
4338228338789338508102.57
5333289333715333502101.06
6343454342887343170103.99
奥司他韦干糖浆项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号101096-202103对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数500
标示量(mg)75供试品稀释倍数5系数0.7612
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.313092083091063093393089923090213091330.05
210.343089313096093092700.16
单位质量响应值RSD%判断
29983.8029910.060.18数据可信
影响因素5天-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
2024051721批1329916329787329852100.31100.222.4797.63%～102.81%
231988531998631993697.29
3339791339763339777103.33
432066332079332072897.53
5330169330362330266100.44
6336852336826336839102.43
2024051721批132407032401232404198.54100.091.5698.46%～101.72%
232440232453132446698.67
3330861330518330690100.56
4332578331991332284101.05
5336997337047337022102.49
632600032659732629899.23
l批132447132472332459798.71102.662.47100.00%～105.32%
2333333333487333410101.39
3335176335479335328101.97
4339992339917339954103.38
5344856344746344801104.86
6347576347322347449105.66
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