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D23106010771对照品来源中检所对照品使用方法直接使用
对照品含量(%)90.12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%
112.557933227956307954077956367955647951120.13
212.547902327880547891430.20
单位质量响应值RSD%判断
63355.5462930.060.48数据可信
加速6月-供试品溶液-2024072721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%
5min1818919-81891997.89295.272.9697.8995.272.96
2771501-77150192.22492.22
3800523-80052395.69395.69
4790810-79081094.53294.53
5828169-82816998.99899.00
6772085-77208592.29492.29
10min1842149-842149100.66997.042.81100.8397.202.81
2784147-78414793.73693.89
3813880-81388097.29097.45
4807735-80773596.55596.71
5832472-83247299.51299.68
6790462-79046294.49194.64
15min1841857-841857100.63497.762.48100.9798.082.48
2796665-79666595.23295.54
3818177-81817797.80498.13
4813426-81342697.23697.55
5840745-840745100.501100.83
6795967-79596795.14995.46
20min1844537-844537100.95598.312.42101.4598.792.42
2799263-79926395.54396.01
3828918-82891899.08899.57
4822033-82203398.26598.75
5840841-840841100.513101.01
6798696-79869695.47595.94
30min1855783-855783102.29998.652.55102.9799.302.55
2808305-80830596.62497.25
3828757-82875799.06899.72
4825758-82575898.71099.35
5836910-836910100.043100.71
6796209-79620995.17895.81
45min1848775-848775101.46198.352.04102.3099.172.04
2806729-80672996.43597.22
3826931-82693198.85099.67
4825429-82542998.67199.48
5826736-82673698.82799.66
6802089-80208995.88196.67
60min1859298-859298102.71998.652.47103.7399.632.47
2812087-81208797.07698.03
3824229-82422998.52799.51
4824565-82456598.56799.54
5832278-83227899.489100.49
6799214-79921495.53796.48
极限1852910-852910101.95698.222.30103.1399.362.30
2811617-81161797.01998.13
3817692-81769297.74698.89
4822046-82204698.26699.40
5829148-82914899.115100.28
6796602-79660295.22596.33
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D23106010771对照品来源中检所对照品使用方法直接使用
对照品含量(%)90.12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%
112.557879807936517944027936587925897924560.33
212.547884187957547920860.66
单位质量响应值RSD%判断
63143.9063164.750.03数据可信
加速6月-供试品溶液-2024072921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%
5min1836270-83627099.94796.323.4299.9596.323.42
2821268-82126898.15498.15
3804876-80487696.19596.20
4756869-75686990.45790.46
5818661-81866197.84397.84
6797811-79781195.35195.35
10min1839868-839868100.37798.362.31100.5498.522.31
2832842-83284299.53799.70
3819457-81945797.93898.10
4787910-78791094.16794.32
5835966-83596699.911100.07
6821973-82197398.23898.40
15min1839430-839430100.32598.562.51100.6698.882.51
2836764-836764100.006100.34
3821588-82158898.19298.52
4784357-78435793.74394.05
5833752-83375299.64699.98
6832031-83203199.44099.76
20min1836422-83642299.96598.321.95100.4798.801.95
2831503-83150399.37799.87
3816247-81624797.55498.04
4793005-79300594.77695.24
5830656-83065699.27699.77
6827922-82792298.94999.44
30min1832513-83251399.49898.801.51100.1799.451.51
2831514-83151499.379100.04
3827258-82725898.87099.52
4801909-80190995.84096.46
5831054-83105499.32499.98
6835651-83565199.873100.53
45min1824056-82405698.48798.991.3599.3299.801.35
2836810-836810100.012100.84
3827618-82761898.91399.73
4808345-80834596.61097.39
5835327-83532799.834100.66
6837250-837250100.064100.88
60min1830336-83033699.23899.250.82100.24100.230.83
2829650-82965099.156100.15
3827952-82795298.95399.93
4819950-81995097.99798.94
5834334-83433499.716100.71
6840237-840237100.421101.41
极限1829489-82948999.13798.930.97100.30100.080.98
2832640-83264099.513100.67
3826753-82675398.81099.95
4813301-81330197.20298.31
5827587-82758798.909100.07
6836947-836947100.028101.18
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D23106010771对照品来源中检所对照品使用方法直接使用
对照品含量(%)90.12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%
112.557839527941737949397950217887087913590.62
212.547930587875987903280.49
单位质量响应值RSD%判断
63056.4963024.560.04数据可信
加速6月-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%
5min1800199-80019995.80995.951.6995.8195.951.69
2825044-82504498.78398.78
3783930-78393093.86193.86
4795382-79538295.23295.23
5799930-79993095.77695.78
6803945-80394596.25796.26
10min1807686-80768696.70597.971.9296.8698.131.92
2845188-845188101.195101.36
3801575-80157595.97396.13
4813223-81322397.36897.53
5814619-81461997.53597.69
6827149-82714999.03599.20
15min1805559-80555996.45098.211.9896.7798.531.99
2849425-849425101.703102.04
3806447-80644796.55796.87
4815108-81510897.59497.91
5818871-81887198.04498.37
6825955-82595598.89299.22
20min1810309-81030997.01998.501.7997.5098.981.79
2850651-850651101.849102.35
3811983-81198397.22097.70
4820619-82061998.25498.74
5817982-81798297.93898.42
6824425-82442598.70999.20
30min1801883-80188396.01098.932.2796.6599.582.27
2857753-857753102.700103.37
3816946-81694697.81498.45
4829723-82972399.34499.99
5819682-81968298.14198.79
6831671-83167199.577100.23
45min1805903-80590396.49298.841.7497.2999.651.74
2849449-849449101.705102.55
3820510-82051098.24199.04
4830936-83093699.489100.30
5823292-82329298.57499.39
6822878-82287898.52499.34
60min1798514-79851495.60799.022.3796.57100.002.36
2858059-858059102.736103.75
3821454-82145498.35499.32
4832930-83293099.728100.71
5820008-82000898.18099.16
6830940-83094099.489100.47
极限1801773-80177395.99798.672.0397.1299.812.03
2852241-852241102.040103.22
3815815-81581597.67898.81
4826088-82608898.908100.05
5820289-82028998.21499.35
6828283-82828399.171100.32
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D23106010771对照品来源中检所对照品使用方法直接使用
对照品含量(%)90.12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%
112.557882887929147934607936777932717923220.29
212.547992827909037950920.75
单位质量响应值RSD%判断
63133.2363404.470.31数据可信
加速6月-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%
5min1747092-74709289.12887.915.8189.1387.915.81
2777521-77752192.75892.76
3677214-67721480.79180.79
4790055-79005594.25394.25
5712219-71221984.96784.97
6717136-71713685.55485.55
10min1796795-79679595.05793.874.5195.2194.014.51
2834272-83427299.52899.68
3732677-73267787.40887.54
4811389-81138996.79896.96
5772523-77252392.16292.30
6773236-77323692.24792.39
15min1801755-80175595.64995.413.7595.9695.723.76
2842229-842229100.478100.80
3755531-75553190.13590.41
4821671-82167198.02598.34
5787148-78714893.90694.20
6790269-79026994.27994.58
20min1803991-80399195.91696.343.3496.3896.803.34
2848522-848522101.228101.72
3765225-76522591.29191.72
4817805-81780597.56498.05
5802092-80209295.68996.14
6807741-80774196.36396.82
30min1812070-81207096.88097.792.3497.5198.422.35
2850788-850788101.499102.16
3791620-79162094.44095.02
4821995-82199598.06498.71
5818575-81857597.65698.27
6823268-82326898.21698.83
45min1811928-81192896.86398.262.0997.6599.052.10
2850468-850468101.460102.29
3801298-80129895.59496.33
4822286-82228698.09898.91
5821735-82173598.03398.81
6834183-83418399.518100.30
60min1810606-81060696.70598.501.8597.6599.441.85
2848415-848415101.216102.21
3811836-81183696.85297.75
4818064-81806497.59598.57
5826124-82612498.55699.49
6838644-838644100.050100.99
极限1811145-81114596.76998.431.4997.8899.551.49
2843271-843271100.602101.77
3817532-81753297.53198.59
4816832-81683297.44898.58
5826981-82698198.65899.76
6834862-83486299.599100.71
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