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500
标示量(mg)20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 11.973856413857173851643855313854453855000.06
2 11.993847823854103850960.12
单位质量响应值RSD%判断
32205.5132118.100.20数据可信
供试品溶液-BXJVV61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%
5min1418278-41827898.578100.081.8298.58100.081.82
2431761-431761101.756101.76
3430445-430445101.445101.45
4432635-432635101.961101.96
5416200-41620098.08898.09
6418532-41853298.63898.64
10min1418347-41834798.59499.471.6298.7699.641.62
2428951-428951101.093101.26
3421137-42113799.25299.42
4431895-431895101.787101.96
5415648-41564897.95898.12
6416419-41641998.14098.30
15min1416345-41634598.12299.181.6798.4599.511.67
2428222-428222100.921101.26
3419595-41959598.88899.22
4430903-430903101.553101.89
5414681-41468197.73098.06
6415273-41527397.87098.20
20min1415279-41527997.87199.161.9598.3699.661.95
2431928-431928101.795102.30
3418745-41874598.68899.19
4430168-430168101.380101.89
5414255-41425597.63098.12
6414096-41409697.59298.08
30min1414096-41409697.59298.721.7098.2599.381.69
2426550-426550100.527101.20
3417043-41704398.28798.95
4428991-428991101.103101.78
5413392-41339297.42698.08
6413091-41309197.35598.01
45min1413675-41367597.49398.511.6598.3199.341.65
2425044-425044100.172101.02
3416620-41662098.18799.01
4428024-428024100.875101.72
5412011-41201197.10197.92
6412645-41264597.25098.07
60min1412565-41256597.23198.341.6798.2199.331.67
2424201-42420199.974100.98
3415635-41563597.95598.95
4427627-427627100.781101.80
5411333-41133396.94197.92
6412166-41216697.13798.12
极限1411673-41167397.02198.091.6298.1699.241.63
2423295-42329599.760100.94
3414950-41495097.79498.95
4425867-425867100.366101.55
5410535-41053596.75397.89
6410812-41081296.81897.96
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500
标示量(mg)20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 11.977715427712707713197707277703847710480.07
2 11.997723297718967721120.04
单位质量响应值RSD%判断
64415.0464396.330.03数据可信
供试品溶液-BXJX091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%
5min1827507-82750797.38799.101.1797.3999.101.16
2846368-84636899.60799.61
3831999-83199997.91697.92
4847946-84794699.79399.79
5851012-851012100.153100.15
6847688-84768899.76299.76
10min1826121-82612197.22499.051.1797.3999.211.17
2851190-851190100.174100.34
3833998-83399898.15198.31
4843914-84391499.31899.48
5850536-850536100.097100.26
6843909-84390999.31799.48
15min1823071-82307196.86598.651.0997.1998.981.09
2841098-84109898.98799.32
3832442-83244297.96898.29
4842385-84238599.13899.47
5848538-84853899.862100.20
6842087-84208799.10399.43
20min1822644-82264496.81598.560.9797.3099.050.97
2839137-83913798.75699.25
3835524-83552498.33198.82
4840910-84091098.96599.46
5846584-84658499.632100.13
6839803-83980398.83499.33
30min1821497-82149796.68098.190.9997.3398.850.99
2836708-83670898.47099.13
3827834-82783497.42698.08
4839642-83964298.81599.48
5844087-84408799.338100.00
6836399-83639998.43499.10
45min1824581-82458197.04398.080.8097.8598.900.80
2835712-83571298.35399.18
3826378-82637897.25498.07
4836783-83678398.47999.31
5841951-84195199.08799.92
6834932-83493298.26199.09
60min1816578-81657896.10197.891.1797.0798.871.17
2833503-83350398.09399.08
3824148-82414896.99297.97
4834218-83421898.17799.17
5840233-84023398.88599.88
6841809-84180999.070100.06
极限1817363-81736396.19397.550.9497.3298.700.94
2831958-83195897.91199.07
3821983-82198396.73797.88
4832715-83271598.00099.15
5838320-83832098.66099.82
6831105-83110597.81198.97
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500
标示量(mg)20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 11.973853683853663850373850043848663851280.06
2 11.993868183859633863900.16
单位质量响应值RSD%判断
32174.4432226.020.12数据可信
供试品溶液-2024072521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%
5min1433438-433438102.029101.080.70102.03101.090.70
2431313-431313101.529101.53
3430590-430590101.358101.36
4428171-428171100.789100.79
5428072-428072100.766100.77
6424976-424976100.037100.04
10min1433584-433584102.063101.101.15102.23101.261.15
2433591-433591102.065102.23
3431955-431955101.680101.85
4429566-429566101.117101.29
5420769-42076999.04799.21
6427394-427394100.606100.77
15min1433688-433688102.088101.041.09102.43101.381.09
2432259-432259101.751102.09
3432162-432162101.728102.07
4429717-429717101.153101.49
5421434-42143499.20399.54
6426141-426141100.311100.65
20min1432669-432669101.848100.871.07102.36101.371.06
2431317-431317101.529102.04
3431921-431921101.672102.18
4428284-428284100.815101.32
5420740-42074099.04099.54
6426071-426071100.295100.80
30min1431561-431561101.587100.511.15102.27101.191.15
2430208-430208101.268101.95
3430081-430081101.239101.92
4427113-427113100.540101.21
5418426-41842698.49599.16
6424620-42462099.953100.62
45min1430283-430283101.286100.231.17102.14101.071.17
2429321-429321101.060101.91
3428849-428849100.948101.79
4425816-425816100.235101.08
5417169-41716998.19999.03
6423228-42322899.625100.46
60min1429381-429381101.074100.021.14102.09101.031.14
2427955-427955100.738101.75
3428296-428296100.818101.83
4425644-425644100.194101.20
5417085-41708598.17999.17
6421081-42108199.120100.12
极限1427304-427304100.58599.811.08101.77100.981.08
2427948-427948100.736101.92
3427171-427171100.554101.74
4423666-42366699.728100.90
5416160-41616097.96299.12
6421740-42174099.275100.44
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500
标示量(mg)20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 11.977712917712337714787714337710667713000.03
2 11.997728697728447728560.01
单位质量响应值RSD%判断
64436.0964458.380.03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%
5min1852320-852320100.24399.730.61100.2499.730.61
2848223-84822399.76199.76
3840595-84059598.86498.86
4851736-851736100.174100.17
5842863-84286399.13099.13
6852192-852192100.228100.23
10min1855780-855780100.650100.260.66100.82100.420.66
2853261-853261100.353100.52
3843243-84324399.17599.34
4854472-854472100.496100.66
5848945-84894599.846100.01
6859014-859014101.030101.20
15min1852990-852990100.321100.060.50100.66100.400.50
2852995-852995100.322100.66
3844626-84462699.33899.67
4851768-851768100.178100.51
5846651-84665199.57699.91
6855696-855696100.640100.98
20min1855003-855003100.55899.930.70101.06100.430.70
2850709-850709100.053100.55
3842459-84245999.08399.58
4851417-851417100.136100.64
5842531-84253199.09199.59
6855792-855792100.651101.15
30min1849958-84995899.96599.700.59100.63100.370.59
2847981-84798199.732100.40
3840190-84019098.81699.48
4849897-84989799.958100.63
5843980-84398099.26299.92
6854302-854302100.476101.15
45min1847693-84769399.69899.460.55100.53100.290.55
2846343-84634399.540100.37
3839220-83922098.70299.53
4848038-84803899.739100.57
5841172-84117298.93299.76
6851540-851540100.151100.99
60min1845222-84522299.40899.180.74100.41100.180.73
2845994-84599499.499100.50
3835358-83535898.24899.24
4844152-84415299.282100.28
5836997-83699798.44099.43
6851987-851987100.203101.21
极限1843603-84360399.21798.980.64100.39100.150.64
2843412-84341299.195100.36
3834343-83434398.12899.28
4843256-84325699.177100.34
5836301-83630198.35999.52
6848800-84880099.829101.00
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