厄贝沙坦非奈利酮片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100607-202305对照品来源自制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500
标示量(mg)150供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.226460136461706464316462916462306462270.03
215.286470816464716467760.07
单位质量响应值RSD%判断
42459.0742328.270.22数据可信
供试品溶液-pH1.2
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
5122601批1726207-726207102.78100.301.5098.73%~101.87%
2703718-70371899.60
3695319-69531998.41
4714703-714703101.15
5706721-706721100.02
6705516-70551699.85
5122901批1712975-712975100.9199.501.0098.46%~100.55%
2700719-70071999.17
3704689-70468999.74
4708414-708414100.26
5694177-69417798.25
6697408-69740898.70
5123001批1712696-712696100.87101.201.2099.93%~102.47%
2706433-70643399.98
3717227-717227101.51
4706916-706916100.05
5717320-717320101.52
6729556-729556103.25
厄贝沙坦非奈利酮片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100607-202305对照品来源自制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500
标示量(mg)150供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.226481706514736491816490326489376493590.20
215.286448226449646448930.02
单位质量响应值RSD%判断
42664.8542205.040.77数据可信
供试品溶液-pH1.2
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
5122601批1703275-70327599.44101.902.1199.65%~104.15%
2708773-708773100.22
3723886-723886102.36
4720585-720585101.89
5720456-720456101.87
6747004-747004105.62
5122901批1725361-725361102.56101.761.8499.80%~103.73%
2705496-70549699.76
3721303-721303101.99
4742388-742388104.97
5712416-712416100.73
6711251-711251100.57
5123001批1717713-717713101.48101.281.5799.61%~102.95%
2711584-711584100.62
3720512-720512101.88
4733777-733777103.75
5699486-69948698.91
6714611-714611101.04
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