磷酸奥司他韦干混悬剂项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号101096-202103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100
标示量(mg)75供试品稀释倍数1系数0.7612
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.741484043149512814913321494527149398714918030.31
29.751501310149006814956890.54
单位质量响应值RSD%判断
153162.53153404.000.12数据可信
影响因素5天-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
2024030121116131941617660161542795.9897.861.7196.10%~99.61%
216213741627377162437696.51
316781501686566168235899.95
416569531667232166209298.75
516654911676640167106699.28
616235971630649162712396.67
20240302211168788316997991693841100.6499.202.3196.81%~101.60%
216790121669371167419299.47
316265721639326163294997.02
416511121626179163864697.36
516483241644064164619497.81
6173678117282451732513102.93
2024030321116357421639807163777497.3097.601.2796.30%~98.90%
216268531634977163091596.90
316790231668701167386299.45
416304561633941163219896.97
516577451666317166203198.75
616209411617717161932996.21
磷酸奥司他韦干混悬剂项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号101096-202103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100
标示量(mg)75供试品稀释倍数1系数0.7612
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.741476601148597714868161486686148696214846080.31
29.751479942148232714811340.12
单位质量响应值RSD%判断
152423.82151911.180.24数据可信
影响因素10天-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
2024030121116645391661392166296699.5397.791.8795.87%~99.70%
216605981669026166481299.64
316221651626101162413397.20
416147571618591161667496.76
515850791587835158645794.95
616434901652966164822898.64
20240302211170505817098501707454102.19101.670.99100.61%~102.73%
2170098617073681704177101.99
3167199516793951675695100.29
4171269117092421710966102.40
5171286417166681714766102.63
6168079916784511679625100.52
20240303211170563416978631701748101.8599.991.9697.94%~102.05%
2170181117046831703247101.94
316667051664833166576999.69
416607521660053166040299.37
5167785116797261678788100.47
616111961618435161481696.64
磷酸奥司他韦干混悬剂项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号101096-202103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100
标示量(mg)75供试品稀释倍数1系数0.7612
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.741488290149288514915071495835150112114939280.33
29.751476140149268314844120.79
单位质量响应值RSD%判断
153380.70152247.380.53数据可信
加速1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
2024030121116510661644388164772798.2098.641.7996.79%~100.49%
2168901416928111690912100.77
316640271677076167055299.56
416745291677209167586999.88
516102471611503161087596.00
616348501635233163504297.44
20240302211171046317033661706914101.73100.171.3998.72%~101.62%
216685821670043166931299.48
316653311667279166630599.31
416571041650071165358898.55
516819301673014167747299.97
6170406917181521711110101.98
20240303211176271717619791762348105.03103.102.65100.23%~105.96%
2176605817667011766380105.27
3177562817905631783096106.27
4168362516830301683328100.32
5167997816820971681038100.18
6170729616995271703412101.52
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