枸橼酸西地那非口崩片项目信息
介质体积(ml)900取样体积(ml)1.0补液体积(ml)0
对照品批号420012-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.8对照品水分(%)0对照品稀释倍数200
标示量(mg)50供试品稀释倍数1系数0.7118
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.164863684859694869394863774861034863510.08
214.074853234856804855020.06
单位质量响应值RSD%判断
34346.8234506.180.33数据可信
供试品溶液-C090402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%
2min1194063-19406335.67944.8729.5935.6844.8729.59
2198062-19806236.41436.41
3214519-21451939.44039.44
4373288-37328868.63068.63
5198213-19821336.44236.44
6286296-28629652.63652.64
5min1507680-50768093.33891.191.6193.3891.241.60
2492419-49241990.53290.57
3490765-49076590.22890.27
4489343-48934389.96690.04
5504528-50452892.75892.80
6491289-49128990.32490.38
10min1529601-52960197.36896.182.3697.5196.332.35
2525818-52581896.67296.81
3532815-53281597.95998.10
4502360-50236092.36092.54
5533765-53376598.13398.28
6514501-51450194.59294.75
15min1528875-52887597.23496.003.0197.4996.262.99
2526983-52698396.88797.14
3535597-53559798.47098.72
4496793-49679391.33691.61
5535348-53534898.42498.68
6509340-50934093.64393.91
20min1529248-52924897.30396.232.4497.6696.592.43
2525267-52526796.57196.93
3535650-53565098.48098.84
4503549-50354992.57892.96
5534109-53410998.19798.56
6512533-51253394.23094.60
30min1526372-52637296.77496.412.4297.2496.882.41
2524350-52435096.40296.87
3539795-53979599.24299.71
4504580-50458092.76893.25
5534785-53478598.32198.79
6516449-51644994.95095.42
45min1530426-53042697.52096.622.3798.0997.192.35
2528100-52810097.09297.66
3537890-53789098.89299.47
4505574-50557492.95093.54
5535279-53527998.41298.99
6515831-51583194.83695.41
极限1529676-52967697.38296.502.3098.0797.182.29
2527968-52796897.06897.75
3536230-53623098.58799.28
4504975-50497592.84093.53
5534348-53434898.24198.93
6516007-51600794.86995.55
枸橼酸西地那非口崩片项目信息
介质体积(ml)900取样体积(ml)1.0补液体积(ml)0
对照品批号420012-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.8对照品水分(%)0对照品稀释倍数200
标示量(mg)50供试品稀释倍数1系数0.7118
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.164837674826224830084826094832814830570.11
214.074835424845604840510.15
单位质量响应值RSD%判断
34114.1934403.060.60数据可信
供试品溶液-C090402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%
2min1344249-34424963.60262.236.2263.6062.236.23
2328132-32813260.62460.62
3327927-32792760.58660.59
4374052-37405269.10869.11
5312495-31249557.73557.73
6334169-33416961.73961.74
5min1511801-51180194.55893.601.1794.6393.671.17
2502192-50219292.78292.85
3512872-51287294.75594.82
4507577-50757793.77793.85
5507977-50797793.85193.92
6497298-49729891.87891.95
10min1522364-52236496.50995.003.7296.6895.183.70
2520762-52076296.21396.38
3526046-52604697.18997.36
4476130-47613087.96788.15
5525176-52517697.02997.20
6514822-51482295.11695.29
15min1522486-52248696.53296.520.7196.8196.790.71
2518128-51812895.72796.00
3527350-52735097.43097.71
4520855-52085596.23096.51
5526144-52614497.20897.48
6519480-51948095.97696.25
20min1522756-52275696.58296.330.7896.9796.720.78
2518367-51836795.77196.15
3527376-52737697.43597.82
4516596-51659695.44395.83
5524056-52405696.82297.21
6519208-51920895.92696.31
30min1522692-52269296.57096.520.7797.0797.010.77
2519740-51974096.02496.51
3528011-52801197.55298.05
4520976-52097696.25396.74
5525924-52592497.16797.66
6517148-51714895.54596.04
45min1510204-51020494.26396.191.3594.8796.791.34
2516863-51686395.49396.09
3529545-52954597.83698.44
4521756-52175696.39797.00
5526824-52682497.33397.93
6518631-51863195.81996.42
极限1506722-50672293.61996.031.4494.3396.741.43
2517083-51708395.53396.24
3526641-52664197.29998.01
4524620-52462096.92697.63
5525020-52502097.00097.71
6518483-51848395.79296.49
枸橼酸西地那非口崩片项目信息
介质体积(ml)900取样体积(ml)1.0补液体积(ml)0
对照品批号420012-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.8对照品水分(%)0对照品稀释倍数200
标示量(mg)50供试品稀释倍数1系数0.7118
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.164828754835344829134827404828144829750.07
214.074843644843444843540.01
单位质量响应值RSD%判断
34108.4034424.590.66数据可信
供试品溶液-C090402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%
2min1248600-24860045.92045.962.9745.9245.962.96
2249015-24901545.99646.00
3254313-25431346.97546.97
4259157-25915747.87047.87
5242649-24264944.82044.82
6239019-23901944.15044.15
5min1285970-28597052.82251.632.5152.8751.682.51
2277559-27755951.26951.32
3283448-28344852.35652.41
4281278-28127851.95652.01
5282568-28256852.19452.24
6266407-26640749.20949.26
10min1264115-26411548.78550.135.4148.9050.245.40
2253646-25364646.85246.96
3258429-25842947.73547.85
4277829-27782951.31951.43
5287501-28750153.10553.21
6286904-28690452.99553.10
15min1266026-26602649.13851.403.1449.3051.573.13
2270348-27034849.93750.10
3279249-27924951.58151.74
4279398-27939851.60851.78
5287724-28772453.14653.31
6286975-28697553.00853.17
20min1257990-25799047.65449.372.2747.8749.592.27
2269477-26947749.77649.99
3269357-26935749.75449.97
4276196-27619651.01751.24
5264428-26442848.84349.07
6266337-26633749.19649.42
30min1254771-25477147.05948.462.1147.3348.742.11
2267227-26722749.36049.63
3257852-25785247.62947.90
4267036-26703649.32549.61
5260021-26002148.02948.31
6267280-26728049.37049.65
45min1253812-25381246.88247.322.5547.2147.652.54
2253931-25393146.90447.23
3255650-25565047.22247.55
4267607-26760749.43049.77
5258149-25814947.68348.02
6248026-24802645.81446.14
极限1245143-24514345.28146.252.4445.6646.642.42
2244424-24442445.14845.53
3252332-25233246.60946.99
4251591-25159146.47246.86
5248005-24800545.81046.20
6260952-26095248.20148.58
枸橼酸西地那非口崩片项目信息
介质体积(ml)900取样体积(ml)1.0补液体积(ml)0
对照品批号420012-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.8对照品水分(%)0对照品稀释倍数200
标示量(mg)50供试品稀释倍数1系数0.7118
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.164824204839374840254842544842244837720.16
214.074859184840844850010.27
单位质量响应值RSD%判断
34164.6934470.580.64数据可信
供试品溶液-C090402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%
2min1218586-21858640.31543.096.6240.3243.096.62
2223129-22312941.15341.15
3220852-22085240.73340.73
4237529-23752943.80943.81
5244186-24418645.03745.04
6257451-25745147.48447.48
5min1297139-29713954.80451.046.3254.8551.096.31
2254189-25418946.88246.93
3274026-27402650.54150.59
4290423-29042353.56553.61
5285988-28598852.74752.80
6258789-25878947.73047.78
10min1261354-26135448.20351.294.5048.3151.404.50
2275611-27561150.83350.93
3285359-28535952.63152.73
4294192-29419254.26054.37
5285447-28544752.64752.76
6266674-26667449.18549.29
15min1267606-26760649.35750.803.4249.5250.963.41
2277352-27735251.15451.31
3265974-26597449.05649.22
4286198-28619852.78652.95
5286730-28673052.88453.05
6268793-26879349.57549.74
20min1254024-25402446.85149.215.5447.0749.435.52
2258309-25830947.64247.85
3271537-27153750.08250.30
4271126-27112650.00650.23
5292191-29219153.89154.12
6253837-25383746.81747.03
30min1255606-25560647.14349.387.2547.4149.657.22
2258415-25841547.66147.93
3254262-25426246.89547.17
4297387-29738754.84955.13
5287211-28721152.97253.26
6253385-25338546.73447.00
45min1255793-25579347.17848.343.3047.5048.683.30
2258942-25894247.75948.08
3265501-26550148.96849.29
4270905-27090549.96550.31
5271534-27153450.08150.43
6250046-25004646.11846.44
极限1245587-24558745.29546.381.7845.6746.761.78
2251223-25122346.33546.70
3248065-24806545.75246.13
4257544-25754447.50147.90
5250777-25077746.25346.65
6255526-25552647.12947.50
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