替米沙坦苯磺酸左氨氯地平片项目信息
介质体积(ml)500取样体积(ml)5补液体积(ml)5
对照品批号100546-202105对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数10000
标示量(mg)2.5供试品稀释倍数5系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.272459924402244432446224596245000.38
213.222475024581246660.49
单位质量响应值RSD%判断
1846.271865.810.75数据可信
加速6月-供试品溶液-pH2.0
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
6087549批126231261162617498.9396.952.8094.11%~99.79%
225422254922545796.22
3264992654126520100.24
424415244652444092.38
525782257712577697.43
625586254612552496.48
6087549批126070261342610298.6696.083.3192.75%~99.42%
224676244512456492.85
326320261482623499.16
424835244812465893.20
524693248002474693.54
626396260402621899.10
6087549批125604256402562296.8598.252.3395.86%~100.65%
225752256302569197.11
3271412711927130102.55
426255261902622299.11
525813256162571497.19
625598255652558296.70
6087549批125056250652506094.7297.793.1294.59%~100.98%
2267532665526704100.94
325577256502561496.82
4268282687626852101.50
526136259372603698.41
625026248892495894.34
替米沙坦苯磺酸左氨氯地平片项目信息
介质体积(ml)500取样体积(ml)5补液体积(ml)5
对照品批号100546-202105对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数10000
标示量(mg)2.5供试品稀释倍数5系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.272444424647245562454224747245870.47
213.222476424657247100.31
单位质量响应值RSD%判断
1852.831869.140.62数据可信
中间条件6月-供试品溶液-pH2.0
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
6087549批124545246252458592.6897.084.4592.55%~101.61%
226603264052650499.91
325625257152567096.77
424378243012434091.76
5273912729227342103.07
626129260292607998.31
6087549批1275512765527603104.0699.103.5095.46%~102.74%
2265522651026531100.02
325456255442550096.13
425929258922591097.67
5269372703426986101.73
625221251732519794.99
6087549批124863249782492093.9499.162.8496.21%~102.11%
2264702671426592100.25
3267072690526806101.05
426181261972618998.73
526394261852629099.11
6271622689027026101.88
6087549批124637245862461292.7897.152.7494.36%~99.94%
2265732659326583100.21
325938259922596597.88
426097260862609298.36
526117260652609198.36
625386251842528595.32
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