艾托格列净片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号741-2407001-D对照品来源自制对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.7719
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.495044255022525022685022525011875024770.24
214.6004974395004964989680.44
单位质量响应值RSD%判断
34677.5034175.891.04数据可信
供试品溶液-pH4.5
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2026032321138048538078538063576.3581.774.9777.51%～86.03%
240976641499341238082.72
343347143331943339586.94
438660838696438678677.59
541051641211841131782.51
642212742044742128784.51
2026032421141964841923141944084.1484.502.6882.13%～86.87%
241899342174342036884.32
340230940269640250280.74
441892241950641921484.09
543307943307443307686.87
643298643273843286286.83
2026032521141284941329541307282.8685.822.7083.40%～88.25%
242404342419442411885.08
344119944143644131888.53
441743641734341739083.73
543230243214543222486.70
644095243680043887688.04
艾托格列净片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号741-2407001-D对照品来源自制对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.7719
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.495022754968375002205013204968754995050.51
214.6004958824963494961160.07
单位质量响应值RSD%判断
34472.3933980.551.02数据可信
供试品溶液-pH4.5
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2026032321146817446746446781994.3999.303.3495.83%～102.78%
2502088501024501556101.20
3504041505056504548101.80
447491547525147508395.86
5504741506842505792102.05
6497615498757498186100.52
2026032421147648747651647650296.1497.641.0696.55%～98.72%
248579848604348592098.04
348125848158848142397.14
448113548404948259297.37
549259049102449180799.23
648548548479848514297.89
2026032521148074648048948061896.9796.931.5195.39%～98.46%
249022449094749058698.98
347881247810047845696.54
447207947190947199495.23
547377047391347384295.61
648681048686548683898.23
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