依折麦布片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号DSZJ-4057-240226对照品来源自制工作对照品对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数2000
标示量(mg)30供试品稀释倍数5系数0.8934
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.852060412062502060802061672058592060790.08
215.822062822059882061350.11
单位质量响应值RSD%判断
13001.8313030.030.16数据可信
加速3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
1批1202230202313202272104.13102.871.42101.34%～104.40%
2199144199149199146102.52
3197905197848197876101.87
4196984196907196946101.39
5198475198446198460102.17
6204215204308204262105.15
1批119141719137419139698.53101.002.4198.45%～103.54%
2195540195425195482100.63
3198532198325198428102.15
419097919055319076698.20
5197834197645197740101.80
6203464203130203297104.66
1批1198472198494198483102.18103.181.44101.63%～104.74%
2199587199606199596102.75
3200338200290200314103.12
4197869197998197934101.90
5200341200293200317103.12
6206003205943205973106.03
依折麦布片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号DSZJ-4057-240226对照品来源自制工作对照品对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数2000
标示量(mg)30供试品稀释倍数5系数0.8934
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.852062792061572058962058252057952059900.11
215.822057072057282057180.01
单位质量响应值RSD%判断
12996.2113003.670.05数据可信
长期3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
1批119205619188419197098.95102.963.1899.53%～106.38%
2206070206139206104106.23
3202616202527202572104.41
4203639203601203620104.95
5202709202758202734104.49
619154519145419150098.70
1批1204608204548204578105.44103.701.87101.67%～105.74%
2198369198592198480102.30
3201274201196201235103.72
4195121195083195102100.56
5203694203676203685104.98
6204269204000204134105.22
1批1195583195532195558100.80102.591.33101.17%～104.02%
2202050201928201989104.11
3198971198991198981102.56
4196874196771196822101.45
5202097201984202040104.14
6198934198770198852102.49
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