厄贝沙坦氢氯噻嗪片项目信息
介质体积(ml)1000取样体积(ml)0补液体积(ml)0
对照品批号100309-201404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10000
标示量(mg)12.5供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.679437994264943189422694169942710.09
212.609548995631955600.11
单位质量响应值RSD%判断
7440.497584.131.36数据可信
长期24月-供试品溶液-氢氯噻嗪-pH1.0
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2023061421批190602905179056096.1697.161.6995.44%～98.88%
291330914239137697.02
393036927979291698.66
492105919939204997.74
588873891728902294.53
693096931109310398.86
2023061521批193753935429364899.4497.791.5096.25%～99.33%
293033930279303098.78
391033909849100896.63
490563908849072496.33
593380932949333799.11
690867907779082296.44
2023061621批1951459507095108100.9999.621.6897.87%～101.36%
293042928559294898.69
392079916259185297.53
492556925089253298.25
5947549483794796100.66
6958259548895656101.57
厄贝沙坦氢氯噻嗪片项目信息
介质体积(ml)1000取样体积(ml)0补液体积(ml)0
对照品批号100607-201804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)150供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.712636902635112641202639642638392638250.09
214.802636802636052636420.03
单位质量响应值RSD%判断
17935.0817813.650.49数据可信
长期24月-供试品溶液-厄贝沙坦-pH1.0
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2023061421批126258926252826255897.9398.351.3796.94%～99.76%
226296326313226304898.11
326618026596226607199.24
426460926458426459698.69
525736425794925765696.10
6267969268384268176100.02
2023061521批1268367268779268573100.1798.741.1197.59%～99.88%
226434126436426435298.60
326036526074326055497.18
426571626559226565499.08
526695926670226683099.52
626244626239626242197.88
2023061621批1271744272151271948101.4399.921.7698.08%～101.75%
226457526456626457098.68
326243826217926230897.84
426445626460426453098.66
5270339270034270186100.77
6275745271873273809102.12
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