盐酸伐地那非口崩片项目信息
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N877-220209对照品来源自制对照品使用方法直接使用
对照品含量(%)99.74对照品水分(%)0对照品稀释倍数250
标示量(mg)40供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.111985431984021984531983651984961984520.04
211.132001502002482001990.04
单位质量响应值RSD%判断
17862.4717987.330.50数据可信
供试品溶液-24041201批-pH3.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1123635-12363561.91658.646.6161.9258.656.61
2103434-10343451.79951.80
3114475-11447557.32957.33
4124319-12431962.25862.26
5116412-11641258.29958.30
6120345-12034560.26860.27
10min1147837-14783774.03673.182.5374.1473.282.53
2147934-14793474.08574.17
3140537-14053770.38070.48
4150870-15087075.55575.66
5143292-14329271.76071.86
6146316-14631673.27473.37
15min1157526-15752678.88878.962.3379.1179.182.33
2160869-16086980.56280.77
3151810-15181076.02676.24
4161678-16167880.96881.20
5155307-15530777.77777.99
6158775-15877579.51479.74
20min1164225-16422582.24382.302.3182.6082.652.31
2168149-16814984.20884.55
3158193-15819379.22279.56
4167692-16769283.97984.34
5161903-16190381.08081.43
6165856-16585683.06083.42
30min1171819-17181986.04685.931.6486.5486.421.64
2174821-17482187.55088.03
3167044-16704483.65584.13
4173712-17371286.99487.50
5169778-16977885.02485.51
6172302-17230286.28886.78
45min1177398-17739888.84089.151.3889.4889.781.38
2181198-18119890.74391.37
3174114-17411487.19687.81
4179302-17930289.79490.44
5176889-17688988.58589.21
6179205-17920589.74590.38
60min1180227-18022790.25790.650.9491.0491.430.95
2183400-18340091.84692.63
3178403-17840389.34390.10
4181675-18167590.98291.78
5180555-18055590.42191.19
6181807-18180791.04891.84
极限1185119-18511992.70792.820.8293.6493.750.81
2186404-18640493.35094.28
3183248-18324891.77092.68
4184345-18434592.31993.27
5187532-18753293.91594.84
6185368-18536892.83193.77
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