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对照品来源自制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%
112.037731367720577712387676027684637704990.31
212.027670117673047671580.03
单位质量响应值RSD%判断
64048.1363823.460.25数据可信
供试品溶液-2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%
5min1782693-78269392.79094.711.7992.7994.711.80
2789391-78939193.58493.58
3812428-81242896.31696.32
4785948-78594893.17693.18
5810091-81009196.03896.04
6812785-81278596.35896.36
10min1822481-82248197.50797.491.0797.6697.651.07
2815138-81513896.63796.79
3831584-83158498.58798.75
4808847-80884795.89196.05
5828771-82877198.25398.41
6827174-82717498.06498.22
15min1828483-82848398.21997.751.0998.5498.071.09
2816650-81665096.81697.13
3833843-83384398.85499.18
4810543-81054396.09296.41
5830605-83060598.47098.79
6826884-82688498.02998.35
20min1828173-82817398.18297.770.9398.6698.250.93
2819848-81984897.19597.67
3830065-83006598.40698.90
4811359-81135996.18996.66
5831152-83115298.53599.02
6827374-82737498.08798.57
30min1832621-83262198.70998.120.9299.3598.770.92
2823806-82380697.66498.30
3830194-83019498.42299.08
4814611-81461196.57497.21
5835908-83590899.09999.75
6828791-82879198.25598.91
45min1835503-83550399.05198.190.9599.8699.000.95
2825453-82545397.86098.66
3828261-82826198.19399.01
4815317-81531796.65897.45
5836956-83695699.223100.04
6827964-82796498.15798.97
60min1833901-83390198.86198.080.9799.8499.060.97
2825660-82566097.88498.85
3826939-82693998.03699.02
4813546-81354696.44897.41
5836363-83636399.153100.14
6827518-82751898.10499.08
90min1833053-83305398.76197.980.9499.9099.110.94
2824452-82445297.74198.87
3825210-82521097.83198.98
4813527-81352796.44697.56
5835402-83540299.039100.19
6826992-82699298.04299.18
120min1-0.0000.00-1.301.300.98
2-0.0001.29
3-0.0001.31
4-0.0001.28
5-0.0001.31
6-0.0001.31
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
极限1-0.0000.00-1.301.300.98
2-0.0001.29
3-0.0001.31
4-0.0001.28
5-0.0001.31
6-0.0001.31
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对照品来源自制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%
112.037689387682137679177673907679057680730.08
212.027695527700797698160.05
单位质量响应值RSD%判断
63846.4764044.590.22数据可信
供试品溶液-2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%
5min1746125-74612588.44292.523.1688.4492.523.16
2773866-77386691.73091.73
3760343-76034390.12790.13
4791344-79134493.80293.80
5805991-80599195.53895.54
6805582-80558295.48995.49
10min1777538-77753892.16595.272.2392.3195.422.24
2794393-79439394.16394.32
3797143-79714394.48994.64
4806273-80627395.57195.73
5824287-82428797.70697.87
6822656-82265697.51397.67
15min1779368-77936892.38295.081.6392.6895.401.63
2798032-79803294.59494.90
3803234-80323495.21195.52
4805059-80505995.42795.74
5818118-81811896.97597.30
6809084-80908495.90496.23
20min1777972-77797292.21795.182.0792.6795.652.07
2799620-79962094.78395.25
3796809-79680994.44994.92
4800168-80016894.84895.32
5820246-82024697.22797.71
6822879-82287997.54098.02
30min1775561-77556191.93195.172.1592.5495.802.15
2800606-80060694.89995.52
3793872-79387294.10194.73
4805576-80557695.48996.12
5819459-81945997.13497.78
6822193-82219397.45898.10
45min1784646-78464693.00895.601.8393.7796.391.84
2809087-80908795.90596.69
3798369-79836994.63495.41
4802714-80271495.14995.94
5825822-82582297.88898.70
6818702-81870297.04497.85
60min1783086-78308692.82395.462.1293.7496.412.12
2808518-80851895.83796.78
3792368-79236893.92394.86
4799235-79923594.73795.69
5826138-82613897.92698.90
6822695-82269597.51898.49
90min1784914-78491493.03995.681.9294.1196.781.92
2815723-81572396.69197.79
3796245-79624594.38395.48
4801350-80135094.98896.10
5824939-82493997.78498.92
6819784-81978497.17398.30
120min1-0.0000.00-1.231.272.04
2-0.0001.26
3-0.0001.25
4-0.0001.27
5-0.0001.30
6-0.0001.29
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
极限1-0.0000.00-1.231.272.04
2-0.0001.26
3-0.0001.25
4-0.0001.27
5-0.0001.30
6-0.0001.29
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对照品来源自制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%
112.037673437682177705697673007665617679980.21
212.027668797673547671160.05
单位质量响应值RSD%判断
63840.2363819.970.03数据可信
供试品溶液-2批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1327311-32731138.86831.2125.4138.8731.2125.41
2276366-27636632.81832.82
3289112-28911234.33234.33
4206205-20620524.48724.49
5158612-15861218.83518.83
6319305-31930537.91737.92
10min1413809-41380949.13942.8512.2649.2042.9012.28
2363037-36303743.11043.16
3376875-37687544.75344.81
4331740-33174039.39439.43
5289895-28989534.42534.46
6389816-38981646.29046.35
15min1479945-47994556.99351.169.0457.1451.289.06
2432066-43206651.30751.43
3445414-44541452.89253.02
4404178-40417847.99648.10
5369835-36983543.91744.01
6453571-45357153.86154.00
20min1529666-52966662.89757.577.0363.1457.787.05
2485845-48584557.69357.91
3501217-50121759.51959.74
4463003-46300354.98155.17
5431199-43119951.20451.37
6497800-49780059.11359.34
30min1596877-59687770.87866.004.9471.2266.304.97
2558040-55804066.26666.57
3570433-57043367.73868.06
4534671-53467163.49163.77
5518208-51820861.53661.78
6556344-55634466.06566.39
45min1647364-64736476.87472.873.6777.3473.283.70
2615543-61554373.09573.51
3628297-62829774.60975.04
4599852-59985271.23271.62
5582767-58276769.20369.55
6608127-60812772.21472.65
60min1682299-68229981.02276.793.4981.6177.333.51
2648247-64824776.97877.52
3661158-66115878.51279.07
4633796-63379675.26275.77
5618887-61888773.49273.96
6635795-63579575.50076.06
90min1714021-71402184.78981.013.3885.5281.683.40
2678825-67882580.61081.28
3703857-70385783.58284.27
4675943-67594380.26780.90
5651366-65136677.34977.94
6669404-66940479.49180.18
120min1731746-73174686.89482.913.3587.7683.713.37
2695916-69591682.63983.44
3720286-72028685.53386.36
4688995-68899581.81782.58
5671347-67134779.72280.44
6680901-68090180.85681.67
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
极限1756793-75679389.86886.062.8890.8887.002.91
2728808-72880886.54587.49
3738850-73885087.73788.71
4715241-71524184.93485.83
5701241-70124183.27184.12
6707644-70764484.03284.98
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