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%
111.977661547656307659907659027658107658970.03
211.997634667635397635020.01
单位质量响应值RSD%判断
63984.7163678.230.34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%
5min1799975-79997594.99490.705.0394.9990.705.03
2790731-79073193.89793.90
3742194-74219488.13388.13
4697501-69750182.82682.83
5767263-76726391.11091.11
6785358-78535893.25993.26
10min1839386-83938699.67495.284.3799.8395.434.37
2831431-83143198.73098.89
3789911-78991193.79993.95
4741335-74133588.03188.17
5802715-80271595.32095.47
6809467-80946796.12296.28
15min1850117-850117100.94997.193.62101.2797.503.63
2840089-84008999.758100.08
3806558-80655895.77696.08
4767980-76798091.19591.48
5832583-83258398.86799.18
6813373-81337396.58596.90
20min1850706-850706101.01997.353.26101.5197.823.27
2841886-84188699.971100.46
3816066-81606696.90597.37
4774455-77445591.96492.40
5822530-82253097.67398.15
6813086-81308696.55197.03
30min1858648-858648101.96298.212.76102.6298.842.76
2842450-842450100.038100.69
3824691-82469197.92998.55
4791579-79157993.99794.59
5827278-82727898.23798.87
6817464-81746497.07197.71
45min1852014-852014101.17498.611.90102.0099.411.91
2841319-84131999.904100.72
3830576-83057698.62899.42
4807782-80778295.92196.67
5831932-83193298.78999.59
6818931-81893197.24598.04
60min1851081-851081101.06398.821.63102.0699.781.64
2840286-84028699.781100.77
3833991-83399199.03499.99
4817146-81714697.03397.94
5834307-83430799.071100.04
6816097-81609796.90997.87
极限1849556-849556100.88299.041.38102.05100.161.39
2837891-83789199.497100.65
3835249-83524999.183100.30
4825962-82596298.08099.15
5838986-83898699.627100.76
6816419-81641996.94798.07
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%
111.977660397647837647937656347656547653810.08
211.997654187657407655790.03
单位质量响应值RSD%判断
63941.6063851.460.10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%
5min1772520-77252091.64093.881.8491.6493.881.84
2813081-81308196.45296.45
3781639-78163992.72292.72
4788845-78884593.57793.58
5802645-80264595.21495.21
6789709-78970993.67993.68
10min1804791-80479195.46996.601.0095.6296.761.00
2824705-82470597.83197.99
3809089-80908995.97896.13
4808975-80897595.96596.12
5822839-82283997.60997.77
6815636-81563696.75596.91
15min1818945-81894597.14897.560.8597.4697.880.85
2825073-82507397.87498.20
3815822-81582296.77797.09
4816201-81620196.82297.14
5834076-83407698.94299.26
6824554-82455497.81398.13
20min1821170-82117097.41197.860.9897.8998.340.97
2827437-82743798.15598.64
3815842-81584296.77997.26
4819315-81931597.19197.67
5838310-83831099.44599.93
6827743-82774398.19198.67
30min1818216-81821697.06197.951.0597.7098.601.05
2824867-82486797.85098.50
3820049-82004997.27997.92
4819892-81989297.26097.90
5840872-84087299.749100.40
6830483-83048398.51699.16
45min1819353-81935397.19698.041.2097.9998.841.20
2823953-82395397.74298.56
3818557-81855797.10297.90
4820031-82003197.27698.08
5843047-843047100.007100.82
6833818-83381898.91299.72
60min1815610-81561096.75297.791.2497.7198.761.24
2821563-82156397.45898.43
3817252-81725296.94797.91
4818416-81841697.08598.05
5841522-84152299.826100.81
6831946-83194698.69099.66
极限1815535-81553596.74397.541.2397.8698.681.23
2817238-81723896.94598.08
3815830-81583096.77897.90
4815927-81592796.79097.91
5839665-83966599.605100.76
6829518-82951898.40299.54
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%
111.977688267686087681377690627682967685860.05
211.997666897656557661720.10
单位质量响应值RSD%判断
64209.3663900.920.35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%
5min1799350-79935094.58989.283.5594.5989.283.55
2768845-76884590.97990.98
3744319-74431988.07788.08
4753214-75321489.12989.13
5723027-72302785.55785.56
6738290-73829087.36387.36
10min1834744-83474498.77793.093.5598.9393.233.55
2804203-80420395.16395.31
3768056-76805690.88691.03
4781056-78105692.42492.57
5761583-76158390.12090.26
6770326-77032691.15491.30
15min1849231-849231100.49194.923.30100.8195.223.29
2813816-81381696.30196.61
3782355-78235592.57892.88
4800644-80064494.74295.04
5778955-77895592.17592.47
6787970-78797093.24293.54
20min1842618-84261899.70995.372.51100.2095.842.52
2816429-81642996.61097.08
3789235-78923593.39293.84
4797052-79705294.31794.78
5795648-79564894.15194.60
6794937-79493794.06794.52
30min1843968-84396899.86996.621.73100.5297.241.74
2819112-81911296.92797.56
3811755-81175596.05796.66
4808396-80839695.65996.28
5807449-80744995.54796.15
6808423-80842395.66296.27
45min1847739-847739100.31597.181.66101.1497.961.67
2819287-81928796.94897.74
3809325-80932595.76996.54
4814706-81470696.40697.18
5821135-82113597.16797.93
6815372-81537296.48597.25
60min1842751-84275199.72597.441.21100.7198.381.21
2819025-81902596.91797.87
3815344-81534496.48197.41
4819149-81914996.93297.87
5824425-82442597.55698.48
6819908-81990897.02197.95
极限1842541-84254199.70097.861.16100.8698.971.16
2816229-81622996.58697.70
3822072-82207297.27898.37
4823431-82343197.43898.54
5833863-83386398.67399.76
6823765-82376597.47898.57
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%
111.977670467676397684267683027675527677930.08
211.997640597654387647480.13
单位质量响应值RSD%判断
64143.1163782.150.40数据可信
供试品溶液-2024073021批-pH1.05
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1825377-82537797.81095.602.9197.8195.602.92
2826453-82645397.93897.94
3762010-76201090.30190.30
4810543-81054396.05296.05
5807883-80788395.73795.74
6808208-80820895.77695.78
10min1834681-83468198.91398.561.3799.0898.721.38
2841333-84133399.70199.86
3809342-80934295.91096.06
4835106-83510698.96399.12
5837588-83758899.25799.42
6832250-83225098.62598.78
15min1835138-83513898.96798.891.0999.2999.211.09
2844152-844152100.035100.36
3817425-81742596.86897.18
4836275-83627599.10299.43
5838884-83888499.41199.74
6835055-83505598.95799.28
20min1835397-83539798.99799.081.0599.4999.571.06
2842921-84292199.889100.39
3819153-81915397.07397.54
4839796-83979699.519100.01
5841737-84173799.749100.24
6837426-83742699.23899.73
30min1834064-83406498.84099.140.8799.5099.800.87
2842790-84279099.874100.54
3823207-82320797.55398.19
4841409-84140999.710100.37
5838476-83847699.362100.02
6839785-83978599.517100.17
45min1833475-83347598.77099.230.5499.59100.050.55
2840316-84031699.580100.41
3831333-83133398.51699.31
4843684-84368499.980100.80
5838395-83839599.353100.18
6836903-83690399.176100.00
60min1832126-83212698.61099.520.6199.60100.500.61
2840948-84094899.655100.65
3835339-83533998.99199.95
4845755-845755100.225101.21
5841992-84199299.779100.77
6842623-84262399.854100.84
极限1831373-83137398.52199.150.6099.67100.300.59
2838833-83883399.405100.57
3839737-83973799.512100.64
4843394-84339499.945101.10
5836173-83617399.089100.24
6830710-83071098.44299.59
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