拉莫三嗪片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
对照品批号100775-201902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200
标示量(mg)50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%
111.081145363114629811457031146177114594411458970.04
211.151144579114520511448920.04
单位质量响应值RSD%判断
103420.31102680.900.51数据可信
中间条件18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
20221020111116377611640441163910101.35101.870.76101.06%~102.68%
2118188411819541181919102.92
3116945311693701169412101.83
4116634111657921166066101.54
5115930311590641159184100.94
6117881411790931178954102.66
2022102111111086441108844110874496.54101.102.5598.41%~103.80%
2116903811689801169009101.79
3119917711988741199026104.41
4115842711584621158444100.87
5117109111703461170718101.94
6116074211609401160841101.08
2022102211111262151126442112632898.0799.111.9297.12%~101.11%
211173921117474111743397.30
3117094511705911170768101.94
4115151211511811151346100.25
511161071116195111615197.19
611476351147569114760299.93
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