阿齐沙坦片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源自制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5000
标示量(mg)20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%
110.01998529985510054599777999731000000.32
29.981002231004911003570.19
单位质量响应值RSD%判断
9990.0110055.810.47数据可信
加速6月-供试品溶液-pH6.8
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2023111721110746810760110753496.2790.974.1886.99%~94.96%
295532959739575285.72
399287993969934288.94
410334110301010317692.37
510447610447110447493.53
699138997199942889.01
2023111821198958992539910688.7389.244.9984.57%~93.91%
210420110410810415493.24
399673999819982789.37
410470410470310470493.74
599361995229944289.03
691090905999084481.33
202311192119999410023910011689.6391.602.8988.83%~94.38%
210294610260710277692.01
310574210564510569494.62
410510410530610520594.19
510223810209010216491.46
697664982909797787.71
阿齐沙坦片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源自制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5000
标示量(mg)20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%
110.01999081004901001551004251001251002210.24
29.9810007299435997540.46
单位质量响应值RSD%判断
10012.099995.390.12数据可信
长期6月-供试品溶液-pH6.8
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2023111721110463210480910472093.9391.423.9187.67%~95.17%
210052910015210034090.00
310557210517610537494.52
410438010475810456993.79
594944947709485785.08
610194610143710169291.21
2023111821110226710232010229491.7591.163.4387.89%~94.44%
210818910817610818297.04
310130510128010129290.86
410027210014110020689.88
599005992769914088.93
698697986569867688.51
2023111921110358010381710369893.0190.272.4587.95%~92.59%
297432973519739287.36
399365998509960889.34
410257310243810250691.94
510209410194010201791.51
698928983159862288.46
阿齐沙坦片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源自制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5000
标示量(mg)20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%
110.019987599577998219980799704997570.12
29.989755897393974760.12
单位质量响应值RSD%判断
9965.739767.131.43数据可信
中间条件6月-供试品溶液-pH6.8
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2023111721110652710748610700697.3391.704.8487.05%~96.36%
210432710376410404694.63
395867961509600887.32
494533939819425785.73
510298810259910279493.50
610102110066210084291.72
2023111821110406710424510415694.7392.193.3288.98%~95.40%
298056981899812289.25
310513610434810474295.27
410281410381210331393.97
510130710122210126492.10
696463966719656787.83
202311192119973110031310002290.9792.462.3890.15%~94.77%
298364987279854689.63
310504010465610484895.36
410114810175410145192.27
510117210071910094691.81
610389710439210414494.72
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