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%
112.113833563826903835543839813835993834360.13
212.143831533826493829010.10
单位质量响应值RSD%判断
31662.7631540.440.28数据可信
供试品溶液-2024072521批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1373969-37396989.69886.475.0989.7086.475.10
2357000-35700085.62885.63
3383527-38352791.99091.99
4347012-34701283.23283.23
5367949-36794988.25488.25
6333636-33363680.02480.02
10min1398239-39823995.51993.791.2095.6793.931.21
2389930-38993093.52693.67
3393079-39307994.28294.43
4389774-38977493.48993.63
5391167-39116793.82393.97
6383910-38391092.08292.22
15min1397537-39753795.35195.291.6495.6695.591.64
2403073-40307396.67996.98
3403410-40341096.75997.07
4400693-40069396.10896.40
5391261-39126193.84594.15
6387634-38763492.97693.26
20min1400624-40062496.09195.361.2896.5695.821.28
2402485-40248596.53897.00
3401690-40169096.34796.82
4396425-39642595.08495.54
5394975-39497594.73695.20
6389235-38923593.36093.80
30min1401812-40181296.37695.611.2197.0096.231.22
2403723-40372396.83597.46
3401308-40130896.25596.89
4393959-39395994.49395.11
5399370-39937095.79096.41
6391555-39155593.91694.51
45min1399327-39932795.78095.170.9396.5795.940.93
2394970-39497094.73595.52
3401651-40165196.33897.13
4393109-39310994.28995.06
5398780-39878095.64996.43
6392757-39275794.20494.96
60min1401321-40132196.25896.030.8697.2196.970.86
2406468-40646897.49398.43
3400236-40023695.99896.95
4399902-39990295.91896.85
5396976-39697695.21696.15
6397378-39737895.31396.22
极限1407044-40704497.63196.481.3298.7497.571.31
2408305-40830597.93499.04
3401036-40103696.19097.30
4404203-40420396.95098.04
5394707-39470794.67295.77
6398096-39809695.48596.55
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%
112.113833883834343827823833923832983832590.08
212.143840003831273835640.17
单位质量响应值RSD%判断
31648.1431595.060.12数据可信
供试品溶液-2024072521批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1373497-37349789.52884.234.3089.5384.234.30
2348827-34882783.61483.61
3353573-35357384.75284.75
4327615-32761578.53078.53
5358336-35833685.89485.89
6346587-34658783.07783.08
10min1403413-40341396.69992.192.7796.8592.332.77
2387626-38762692.91593.05
3381426-38142691.42891.57
4371717-37171789.10189.23
5379618-37961890.99591.14
6383796-38379691.99692.13
15min1419820-419820100.63194.623.76100.9494.913.75
2387666-38766692.92493.22
3381837-38183791.52791.82
4382431-38243191.66991.95
5404401-40440196.93597.23
6392243-39224394.02194.31
20min1406650-40665097.47594.871.5397.9595.321.54
2396008-39600894.92495.37
3392467-39246794.07594.52
4388687-38868793.16993.60
5394205-39420594.49194.95
6396689-39668995.08795.54
30min1406893-40689397.53395.541.5698.1796.151.57
2397782-39778295.34995.96
3392793-39279394.15394.76
4390445-39044593.59094.18
5400399-40039995.97696.59
6403091-40309196.62197.23
45min1415751-41575199.65694.943.85100.4695.713.82
2391195-39119593.77094.54
3393341-39334194.28495.04
4393708-39370894.37295.12
5372734-37273489.34590.12
6409809-40980998.23299.00
60min1402068-40206896.37694.981.2197.3595.911.20
2392026-39202693.96994.89
3394204-39420494.49195.41
4402537-40253796.48997.39
5392590-39259094.10495.03
6394138-39413894.47595.41
极限1409354-40935498.12396.231.9599.2597.311.94
2395031-39503194.68995.77
3390939-39093993.70994.78
4399358-39935895.72796.79
5403487-40348796.71697.80
6410479-41047998.39299.48
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%
112.113830603833053830273833993823293830240.11
212.143845933843073844500.06
单位质量响应值RSD%判断
31628.7431668.040.09数据可信
供试品溶液-2024072522批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1329354-32935478.88077.8512.6278.8877.8512.62
2348685-34868583.51083.51
3332195-33219579.56079.56
4334106-33410680.01880.02
5245015-24501558.68158.68
6360887-36088786.43286.43
10min1367637-36763788.04889.177.4388.1889.307.44
2391935-39193593.86894.01
3394509-39450994.48494.62
4376778-37677890.23890.37
5319612-31961276.54776.64
6383482-38348291.84391.99
15min1372511-37251189.21691.016.9789.4991.296.98
2391575-39157593.78294.08
3408512-40851297.83898.13
4380671-38067191.17091.45
5332176-33217679.55679.78
6394535-39453594.49194.79
20min1386429-38642992.54993.114.7892.9893.544.80
2402724-40272496.45296.90
3406859-40685997.44297.90
4384787-38478792.15692.59
5355273-35527385.08785.45
6396558-39655894.97595.43
30min1385270-38527092.27293.943.4592.8594.533.47
2406983-40698397.47298.08
3409462-40946298.06698.68
4384720-38472092.14092.73
5375075-37507589.83090.33
6392004-39200493.88494.50
45min1384977-38497792.20194.963.2992.9495.703.29
2404576-40457696.89597.67
3415986-41598699.628100.41
4381919-38191991.46992.21
5390532-39053293.53294.18
6400971-40097196.03296.80
60min1389286-38928693.23395.233.7694.1296.133.77
2403734-40373496.69497.63
3419559-419559100.484101.43
4381613-38161391.39692.29
5384269-38426992.03292.84
6407308-40730897.55098.48
极限1387523-38752392.81196.392.7493.8697.452.74
2408161-40816197.75498.85
3418568-418568100.246101.36
4393504-39350494.24495.29
5401392-40139296.13397.09
6405707-40570797.16698.26
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%
112.113832563839113836243836593836723836240.07
212.143845093846933846010.04
单位质量响应值RSD%判断
31678.2831680.480.01数据可信
供试品溶液-2024072522批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1371491-37149188.88485.004.6388.8885.004.64
2369534-36953488.41688.42
3365996-36599687.57087.57
4330325-33032579.03579.03
5349634-34963483.65583.65
6344470-34447082.41982.42
10min1396348-39634894.83293.032.5594.9893.182.56
2400723-40072395.87996.03
3388440-38844092.94093.09
4372055-37205589.01989.15
5385570-38557092.25392.39
6389875-38987593.28393.42
15min1395604-39560494.65494.112.8394.9694.412.83
2406705-40670597.31097.62
3396135-39613594.78195.08
4372848-37284889.20989.49
5393380-39338094.12294.41
6395382-39538294.60194.89
20min1386841-38684192.55794.441.9993.0294.891.99
2402271-40227196.24996.72
3396487-39648794.86595.32
4386179-38617992.39992.83
5391517-39151793.67694.13
6404844-40484496.86597.32
30min1395169-39516994.55094.861.4595.1795.471.46
2397456-39745695.09795.73
3400566-40056695.84196.46
4385563-38556392.25192.83
5399145-39914595.50196.11
6400841-40084195.90796.52
45min1399717-39971795.63894.832.2296.4195.602.22
2406216-40621697.19397.98
3394498-39449894.38995.17
4387860-38786092.80193.54
5384963-38496392.10892.87
6404855-40485596.86797.64
60min1395906-39590694.72693.911.3995.6694.831.39
2396923-39692394.96995.92
3387387-38738792.68893.62
4387204-38720492.64493.54
5388240-38824092.89293.81
6399203-39920395.51596.45
极限1395458-39545894.61994.860.7395.7195.940.73
2401469-40146996.05797.17
3392815-39281593.98795.07
4395945-39594594.73595.78
5395827-39582794.70795.78
6397335-39733595.06896.16
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