枸橼酸西地那非片项目信息
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420012-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.8对照品水分(%)0对照品稀释倍数500
标示量(mg)25供试品稀释倍数1系数0.7118
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
117.272385222390242391032402292393292392410.27
217.232395222394822395020.02
单位质量响应值RSD%判断
13852.9813900.290.25数据可信
供试品溶液-2024051612批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1266702-26670297.31797.921.2897.3297.921.27
2267234-26723497.51297.51
3270113-27011398.56298.56
4273842-27384299.92399.92
5263771-26377196.24896.25
6268400-26840097.93797.94
10min1273273-27327399.71599.161.5499.8899.321.54
2268906-26890698.12298.28
3272400-27240099.39799.56
4278728-278728101.706101.87
5266692-26669297.31497.47
6270470-27047098.69298.86
15min1273498-27349899.79798.941.59100.1399.271.58
2268653-26865398.02998.36
3270619-27061998.74799.08
4278153-278153101.496101.83
5265660-26566096.93797.26
6270272-27027298.62098.95
20min1272543-27254399.44998.731.6399.9499.231.63
2267584-26758497.63998.13
3271055-27105598.90699.40
4277895-277895101.402101.91
5265287-26528796.80197.29
6269128-26912898.20398.69
30min1272668-27266899.49498.611.57100.1599.271.57
2267881-26788197.74898.40
3270605-27060598.74299.40
4276864-276864101.025101.70
5264552-26455296.53397.18
6268962-26896298.14298.80
45min1270470-27047098.69298.571.1999.5299.391.19
2267035-26703597.43998.25
3269358-26935898.28799.11
4276215-276215100.789101.63
5269352-26935298.28499.09
6268376-26837697.92898.75
极限1270158-27015898.57997.971.5399.5798.961.53
2265872-26587297.01597.99
3268715-26871598.05299.04
4275537-275537100.541101.55
5263870-26387096.28497.25
6266809-26680997.35798.34
枸橼酸西地那非片项目信息
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420012-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.8对照品水分(%)0对照品稀释倍数500
标示量(mg)25供试品稀释倍数1系数0.7118
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
117.272388662383322389082398212387542389360.23
217.232404302413472408880.27
单位质量响应值RSD%判断
13835.3213980.730.74数据可信
供试品溶液-2024051612批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1266099-26609996.88197.041.5996.8897.041.59
2269745-26974598.20898.21
3266735-26673597.11297.11
4259162-25916294.35594.36
5266081-26608196.87496.87
6271445-27144598.82798.83
10min1269098-26909897.97397.941.4298.1398.101.42
2272643-27264399.26399.43
3270357-27035798.43198.59
4262712-26271295.64895.80
5266736-26673697.11397.27
6272528-27252899.22199.39
15min1267868-26786897.52598.432.5397.8598.762.52
2272488-27248899.20799.54
3269684-26968498.18698.51
4262715-26271595.64995.97
5266794-26679497.13497.46
6282625-282625102.897103.23
20min1267905-26790597.53897.611.3898.0398.101.38
2271874-27187498.98399.48
3269941-26994198.27998.77
4262000-26200095.38895.86
5265882-26588296.80297.29
6270948-27094898.64699.15
30min1266802-26680297.13797.461.5197.7998.121.50
2272317-27231799.14499.80
3269352-26935298.06598.72
4261567-26156795.23195.87
5265094-26509496.51597.16
6271090-27109098.69899.36
45min1266350-26635096.97297.301.5297.7898.121.52
2272063-27206399.05299.88
3268570-26857097.78098.60
4260937-26093795.00195.80
5265002-26500296.48197.29
6270662-27066298.54299.37
极限1265589-26558996.69597.391.3797.6798.361.37
2270576-27057698.51199.50
3268849-26884997.88298.86
4260897-26089794.98795.94
5269091-26909197.97098.94
6269930-26993098.27599.27
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