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%
117.362383732384782381392381582383402382980.07
217.312375882375042375460.03
单位质量响应值RSD%判断
13726.8413723.050.02数据可信
供试品溶液-2024051611批-pH2.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1262772-26277296.94397.001.6696.9497.001.67
2259766-25976695.83495.83
3255913-25591394.41294.41
4266550-26655098.33798.34
5265735-26573598.03698.04
6266796-26679698.42798.43
10min1271844-271844100.29099.501.23100.4599.661.23
2265169-26516997.82797.99
3265730-26573098.03498.19
4271895-271895100.309100.47
5271662-271662100.223100.39
6271920-271920100.318100.48
15min1270966-27096699.96699.061.79100.2999.391.79
2265120-26512097.80998.13
3260361-26036196.05396.37
4272799-272799100.642100.97
5271531-271531100.174100.50
6270319-27031999.727100.06
20min1271647-271647100.21799.011.80100.7199.511.80
2264236-26423697.48397.97
3260566-26056696.12996.61
4272182-272182100.414100.91
5271318-271318100.096100.59
6270382-27038299.750100.25
30min1269986-26998699.60498.601.94100.2799.261.94
2263243-26324397.11797.76
3258560-25856095.38996.03
4271315-271315100.095100.76
5270406-27040699.759100.42
6270119-27011999.653100.32
45min1269834-26983499.54898.461.84100.3899.281.83
2263215-26321597.10697.92
3258591-25859195.40096.20
4270867-27086799.929100.76
5269593-26959399.459100.29
6269146-26914699.294100.12
极限1268629-26862999.10498.251.81100.1099.241.81
2262143-26214396.71197.68
3258558-25855895.38896.35
4270552-27055299.813100.81
5269030-26903099.252100.25
6269005-26900599.242100.24
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%
117.362374992371572371742374282374932373500.08
217.312358172363722360940.17
单位质量响应值RSD%判断
13672.2413639.170.18数据可信
供试品溶液-2024051611批-pH2.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1263962-26396297.87697.012.5397.8897.012.53
2259289-25928996.14396.14
3261931-26193197.12397.12
4252405-25240593.59193.59
5272526-272526101.051101.05
6259598-25959896.25896.26
10min1273268-273268101.326100.480.69101.49100.650.69
2270416-270416100.269100.43
3270296-270296100.224100.39
4272323-272323100.976101.13
5271709-271709100.748100.92
6267984-26798499.36799.53
15min1274000-274000101.598100.910.66101.93101.240.66
2270767-270767100.399100.73
3272160-272160100.916101.24
4273667-273667101.474101.80
5272902-272902101.191101.53
6269348-26934899.873100.20
20min1274366-274366101.734100.930.74102.23101.420.74
2270082-270082100.145100.64
3273007-273007101.230101.73
4273674-273674101.477101.97
5272628-272628101.089101.59
6269396-26939699.891100.38
30min1273650-273650101.468101.020.71102.14101.680.71
2270163-270163100.175100.84
3273804-273804101.525102.19
4274283-274283101.703102.37
5272795-272795101.151101.82
6269904-269904100.079100.74
45min1274074-274074101.625101.050.59102.47101.880.59
2271000-271000100.485101.31
3271677-271677100.737101.57
4274377-274377101.738102.57
5273319-273319101.345102.19
6270707-270707100.377101.20
极限1273081-273081101.257100.980.47102.27101.980.47
2270850-270850100.430101.43
3272809-272809101.156102.16
4273729-273729101.497102.50
5272819-272819101.160102.17
6270676-270676100.365101.36
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