盐酸伐地那非片项目信息
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2.0对照品来源中检所对照品使用方法直接使用
对照品含量(%)90.50对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数0.9306
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.117596997594537564367598037563777583540.24
212.147610637607687609160.03
单位质量响应值RSD%判断
62622.1362678.420.07数据可信
供试品溶液-2024073021批-pH1.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1808565-80856597.82498.821.4997.8298.821.49
2806375-80637597.55997.56
3838595-838595101.457101.46
4823076-82307699.58099.58
5811956-81195698.23498.23
6812201-81220198.26498.26
10min1829531-829531100.361100.771.31100.52100.931.31
2820516-82051699.27099.43
3850849-850849102.940103.11
4839972-839972101.624101.79
5826370-82637099.978100.14
6830086-830086100.428100.59
15min1832240-832240100.688100.781.42101.02101.111.41
2818347-81834799.00899.34
3851120-851120102.973103.31
4841310-841310101.786102.12
5824664-82466499.772100.10
6830134-830134100.434100.76
20min1832638-832638100.737100.851.33101.23101.351.33
2819239-81923999.11699.61
3851123-851123102.973103.49
4840763-840763101.720102.22
5828592-828592100.247100.74
6828967-828967100.293100.79
30min1832172-832172100.680100.631.52101.35101.301.52
2816993-81699398.84499.50
3851165-851165102.978103.66
4841070-841070101.757102.43
5822189-82218999.472100.14
6827088-827088100.065100.73
45min1831497-831497100.599100.571.41101.43101.411.41
2817657-81765798.92499.75
3848532-848532102.660103.52
4840023-840023101.630102.47
5820492-82049299.267100.10
6829325-829325100.336101.17
60min1830316-830316100.456100.311.57101.46101.311.57
2811880-81188098.22599.21
3847498-847498102.534103.56
4839176-839176101.528102.54
5819014-81901499.088100.08
6826804-826804100.031101.03
极限1828578-828578100.245100.311.26101.41101.481.26
2814658-81465898.56199.71
3844034-844034102.115103.31
4837592-837592101.336102.52
5826403-82640399.982101.14
6823558-82355899.638100.80
盐酸伐地那非片项目信息
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2.0对照品来源中检所对照品使用方法直接使用
对照品含量(%)90.50对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数0.9306
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.117619857620427615517604657602517612590.12
212.147616327622037619180.06
单位质量响应值RSD%判断
62862.0162760.960.12数据可信
供试品溶液-2024073021批-pH1.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1782808-78280894.46593.353.3994.4693.353.39
2792730-79273095.66295.66
3807835-80783597.48597.49
4734955-73495588.69088.69
5764375-76437592.24192.24
6758822-75882291.57091.57
10min1820462-82046299.00998.081.4199.1798.241.41
2818134-81813498.72898.89
3826564-82656499.74599.91
4794718-79471895.90296.05
5806508-80650897.32597.48
6810093-81009397.75897.91
15min1826182-82618299.69998.900.99100.0299.220.99
2822226-82222699.22299.55
3829376-829376100.084100.41
4810794-81079497.84298.15
5809451-80945197.68098.00
6819116-81911698.84699.16
20min1825193-82519399.58099.060.83100.0799.550.84
2823439-82343999.36899.86
3828103-82810399.931100.43
4813204-81320498.13398.60
5811630-81163097.94398.42
6823863-82386399.41999.90
30min1825291-82529199.59299.440.66100.25100.100.67
2824823-82482399.535100.19
3829778-829778100.133100.80
4819163-81916398.85299.49
5816183-81618398.49299.13
6829175-829175100.060100.71
45min1823908-82390899.42599.650.63100.25100.470.63
2824107-82410799.449100.27
3830316-830316100.198101.03
4825609-82560999.630100.43
5818149-81814998.73099.54
6832611-832611100.475101.29
60min1820258-82025898.98499.620.6199.97100.600.60
2824122-82412299.450100.44
3828578-82857899.988100.98
4828740-828740100.008100.97
5819580-81958098.90299.87
6831698-831698100.365101.34
极限1819596-81959698.90499.610.71100.06100.750.70
2822218-82221899.221100.37
3828075-82807599.928101.09
4830712-830712100.246101.38
5819228-81922898.860100.00
6832616-832616100.475101.62
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