厄贝沙坦非奈利酮片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100607-202305对照品来源自制对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数500
标示量(mg)150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%
115.226460166461956467736471166468346465870.08
215.286468066466286467170.02
单位质量响应值RSD%判断
42482.7242324.410.27数据可信
供试品溶液-pH1.2
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
5122601批1710172710002710087100.4897.442.2095.20%～99.69%
268035868062568049296.29
367800967814267807695.95
470557770609870583899.87
567635767620867628295.69
668109268101268105296.37
5122901批1707599707391707495100.1195.702.6093.10%～98.31%
267240267282867261595.17
366975467023666999594.80
465387165390465388892.52
567528067520467524295.55
667857167912067884696.06
5123001批168417568483668450696.8695.862.7993.06%～98.67%
268010868006768008896.23
365328865363365346092.46
465637065618165627692.86
568979569021569000597.63
670088070059270073699.15
厄贝沙坦非奈利酮片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100607-202305对照品来源自制对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数500
标示量(mg)150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%
115.226484526484076496456493176489666489570.09
215.286452276442986447620.11
单位质量响应值RSD%判断
42638.4442196.470.74数据可信
供试品溶液-pH1.2
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
5122601批170091870102470097199.1698.400.7397.66%～99.14%
269948370024169986299.00
369881369806669844098.80
469346669427269386998.15
569249669266169257897.97
668813168790668801897.32
5122901批1714457715671715064101.1597.393.2294.10%～100.68%
268263268321868292596.60
370290070292870291499.43
470294370335670315099.46
565664066082765873493.18
666808766841166824994.53
5123001批168512368435968474196.8697.140.8596.28%～98.01%
268403668446868425296.79
368971968984568978297.57
468708468810668759597.26
567824367849267836895.96
669707569430469569098.41
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