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)5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%
1 11.973828623828613826213822093816033824310.14
2 11.993832083827043829560.10
单位质量响应值RSD%判断
31949.1231939.620.03数据可信
供试品溶液-2024072522批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1190670-19067090.48490.331.7390.4890.331.73
2194043-19404392.08592.08
3186778-18677888.63788.64
4186198-18619888.36288.36
5193486-19348691.82091.82
6190897-19089790.59290.59
10min1201589-20158995.66695.253.0795.8295.403.07
2194977-19497792.52892.68
3197168-19716893.56893.72
4212238-212238100.719100.87
5200873-20087395.32695.48
6197463-19746393.70893.86
15min1205798-20579897.66396.702.9997.9797.002.99
2201382-20138295.56895.88
3199484-19948494.66794.97
4215265-215265102.156102.47
5201111-20111195.43995.75
6199518-19951894.68394.99
20min1206423-20642397.96096.463.3398.4396.933.32
2200875-20087595.32795.79
3199869-19986994.85095.31
4215521-215521102.277102.76
5196845-19684593.41493.89
6200101-20010194.96095.42
30min1205571-20557197.55597.104.8598.1997.734.83
2203766-20376696.69997.32
3198949-19894994.41395.03
4223614-223614106.118106.77
5196345-19634593.17793.80
6199393-19939394.62495.25
45min1207623-20762398.52996.574.0099.3397.363.99
2196277-19627793.14593.93
3200221-20022195.01795.79
4218123-218123103.512104.34
5200672-20067295.23196.01
6198106-19810694.01394.79
60min1204180-20418096.89596.703.1297.8697.663.11
2203065-20306596.36697.31
3199942-19994294.88495.82
4215846-215846102.432103.44
5197765-19776593.85194.79
6201868-20186895.79896.74
极限1207661-20766198.54796.853.4099.6797.963.39
2202551-20255196.12297.23
3199663-19966394.75295.85
4216487-216487102.736103.91
5199772-19977294.80495.90
6198359-19835994.13395.23
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)5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%
1 11.973838733835333842093834713831563836480.11
2 11.993828223828133828180.01
单位质量响应值RSD%判断
32050.7931928.110.28数据可信
供试品溶液-2024072522批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1202109-20210995.77888.626.4595.7888.626.45
2198231-19823193.94093.94
3182311-18231186.39686.40
4176422-17642283.60583.60
5172057-17205781.53681.54
6190938-19093890.48490.48
10min1203516-20351696.44596.112.9396.6096.262.94
2208899-20889998.99599.15
3201096-20109695.29895.44
4197298-19729893.49893.64
5195755-19575592.76792.90
6210274-21027499.64799.80
15min1220411-220411104.45198.884.20104.7799.184.19
2210054-21005499.54399.86
3211051-211051100.015100.32
4199260-19926094.42894.72
5197537-19753793.61193.90
6213608-213608101.227101.54
20min1208383-20838398.75197.233.4899.2597.703.48
2211561-211561100.257100.74
3202920-20292096.16296.63
4198178-19817893.91594.37
5196358-19635893.05293.50
6213605-213605101.226101.71
30min1209432-20943299.24897.533.0399.9198.163.03
2208148-20814898.64099.29
3201643-20164395.55796.19
4206366-20636697.79598.40
5195813-19581392.79493.40
6213404-213404101.130101.78
45min1208467-20846798.79197.394.0999.6298.194.09
2216674-216674102.680103.50
3201155-20115595.32696.11
4199579-19957994.57995.35
5194744-19474492.28893.04
6212504-212504100.704101.53
60min1208795-20879598.94697.043.2299.9498.003.23
2210200-21020099.612100.60
3200910-20091095.21096.16
4199203-19920394.40195.33
5196818-19681893.27094.18
6212668-212668100.782101.77
极限1207900-20790098.52297.223.6899.6898.343.68
2216082-216082102.399103.56
3201478-20147895.47996.59
4200641-20064195.08296.17
5195041-19504192.42893.49
6209781-20978199.413100.57
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)5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%
1 11.973827263837153841863838963830193835080.16
2 11.993838873834793836830.08
单位质量响应值RSD%判断
32039.1032000.250.09数据可信
供试品溶液-2024072621批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1197289-19728993.40594.313.1193.4194.323.11
2197184-19718493.35593.36
3188948-18894889.45689.46
4206433-20643397.73497.73
5201876-20187695.57795.58
6203524-20352496.35796.36
10min1203698-20369896.43998.321.8096.5998.481.80
2205185-20518597.14397.30
3204012-20401296.58896.74
4211164-21116499.974100.14
5211023-21102399.907100.07
6210961-21096199.878100.04
15min1203292-20329296.24797.332.5896.5697.652.58
2200286-20028694.82495.14
3199364-19936494.38794.70
4211534-211534100.149100.48
5208420-20842098.67599.00
6210560-21056099.688100.02
20min1202855-20285596.04097.592.2596.5298.072.25
2204947-20494797.03197.51
3199187-19918794.30494.77
4211460-211460100.114100.61
5209684-20968499.27399.76
6208610-20861098.76599.26
30min1198701-19870194.07497.502.9694.7198.142.95
2211350-211350100.062100.70
3198341-19834193.90394.53
4212161-212161100.446101.11
5208614-20861498.76799.42
6206432-20643297.73498.39
45min1201198-20119895.25697.272.6696.0598.082.66
2201987-20198795.62996.43
3198727-19872794.08694.87
4211441-211441100.105100.94
5208792-20879298.85199.67
6210578-21057899.697100.52
60min1201935-20193595.60597.552.2096.5698.522.20
2203885-20388596.52897.49
3200382-20038294.86995.81
4210997-21099799.895100.89
5209502-20950299.187100.17
6209551-20955199.210100.20
极限1203261-20326196.23297.612.1097.3498.742.10
2203210-20321096.20897.33
3200740-20074095.03996.13
4211464-211464100.116101.28
5208604-20860498.76299.91
6209700-20970099.281100.43
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)5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%
1 11.973823863823723852543834833833713833730.31
2 11.993841003834113837560.13
单位质量响应值RSD%判断
32027.8232006.340.05数据可信
供试品溶液-2024072621批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1204310-20431096.73793.482.3596.7493.482.36
2201062-20106295.19995.20
3194207-19420791.95391.95
4195808-19580892.71192.71
5197650-19765093.58493.58
6191602-19160290.72090.72
10min1208073-20807398.51996.421.6998.6896.581.69
2207159-20715998.08698.24
3201125-20112595.22995.38
4199718-19971894.56394.72
5204309-20430996.73696.89
6201489-20148995.40195.55
15min1207197-20719798.10497.061.7898.4397.381.78
2210843-21084399.830100.15
3202599-20259995.92796.24
4200465-20046594.91695.23
5205025-20502597.07597.39
6203878-20387896.53296.84
20min1206705-20670597.87196.631.9498.3697.111.93
2206918-20691897.97298.46
3202203-20220395.73996.21
4197130-19713093.33793.81
5207399-20739998.19998.68
6204155-20415596.66397.13
30min1205097-20509797.11096.721.8297.7697.361.81
2209422-20942299.15799.81
3199995-19999594.69495.33
4201963-20196395.62696.25
5207566-20756698.27998.92
6201645-20164595.47596.11
45min1206453-20645397.75297.151.2498.5797.961.24
2209047-20904798.98099.80
3203169-20316996.19796.99
4201908-20190895.60096.38
5205806-20580697.44598.25
6204763-20476396.95197.74
60min1206077-20607797.57496.191.5798.5597.151.57
2207843-20784398.41099.39
3200241-20024194.81095.76
4200478-20047894.92395.87
5203212-20321296.21797.19
6201078-20107895.20796.16
极限1205736-20573697.41296.141.6498.5597.271.64
2208232-20823298.59499.74
3199190-19919094.31395.42
4201021-20102195.18096.28
5201841-20184195.56896.70
6202329-20232995.79996.91
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