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%
112.117636787627627628917624717598317623270.20
212.147637797640757639270.03
单位质量响应值RSD%判断
62950.2162926.440.03数据可信
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%
5min1840724-840724101.24999.651.68101.2599.651.68
2803615-80361596.78096.78
3825803-82580399.45299.45
4837171-837171100.821100.82
5836278-836278100.714100.71
6821191-82119198.89798.90
10min1851186-851186102.509101.081.58102.68101.251.58
2816673-81667398.35398.51
3840804-840804101.259101.42
4847226-847226102.032102.20
5848745-848745102.215102.38
6831383-831383100.124100.29
15min1849016-849016102.248100.871.49102.59101.211.49
2816127-81612798.28798.61
3840372-840372101.207101.54
4843998-843998101.644101.98
5846194-846194101.908102.25
6829893-82989399.945100.28
20min1849189-849189102.269100.771.57102.78101.271.57
2814148-81414898.04998.54
3840232-840232101.190101.69
4843181-843181101.545102.05
5845156-845156101.783102.29
6828625-82862599.792100.29
30min1849162-849162102.266100.661.57102.95101.331.57
2813548-81354897.97798.63
3839862-839862101.146101.82
4841940-841940101.396102.07
5843122-843122101.538102.22
6827391-82739199.644100.31
45min1850595-850595102.438100.621.63103.29101.461.63
2812563-81256397.85898.67
3839042-839042101.047101.89
4840634-840634101.239102.08
5843249-843249101.553102.40
6827105-82710599.609100.44
60min1845784-845784101.859100.341.46102.88101.341.46
2811763-81176397.76298.74
3838263-838263100.953101.96
4838771-838771101.014102.03
5837645-837645100.879101.89
6826672-82667299.557100.55
极限1844632-844632101.720100.231.54102.91101.401.54
2810160-81016097.56998.71
3837809-837809100.898102.08
4837652-837652100.879102.06
5839394-839394101.089102.27
6823997-82399799.235100.40
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%
112.117644237652457644227639537639417643970.07
212.147691757677957684850.13
单位质量响应值RSD%判断
63121.1463301.890.21数据可信
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%
5min1801658-80165896.12897.302.0396.1397.302.03
2834844-834844100.107100.11
3787827-78782794.46994.47
4805938-80593896.64196.64
5817515-81751598.02998.03
6820607-82060798.40098.40
10min1837310-837310100.403100.161.67100.56100.331.67
2857429-857429102.815102.98
3814418-81441897.65897.82
4832219-83221999.79299.95
5839244-839244100.635100.80
6831309-83130999.68399.85
15min1833534-83353499.950100.321.59100.28100.641.59
2858894-858894102.991103.33
3820072-82007298.33698.66
4833172-83317299.906100.23
5843734-843734101.173101.50
6830112-83011299.54099.87
20min1833828-83382899.985100.261.61100.48100.761.60
2857715-857715102.849103.36
3820060-82006098.33498.82
4833026-83302699.889100.38
5845004-845004101.325101.82
6827326-82732699.20599.70
30min1838470-838470100.542100.471.66101.20101.131.66
2858807-858807102.980103.66
3821630-82163098.52299.17
4830819-83081999.624100.28
5848993-848993101.804102.47
6828566-82856699.354100.02
45min1837846-837846100.467100.431.62101.30101.261.62
2859159-859159103.023103.88
3823824-82382498.78699.60
4831322-83132299.685100.51
5846951-846951101.559102.40
6826242-82624299.07599.90
60min1837652-837652100.444100.281.64101.44101.281.64
2857793-857793102.859103.88
3822893-82289398.67499.65
4829393-82939399.453100.45
5846183-846183101.467102.47
6824036-82403698.81199.80
极限1835571-835571100.194100.021.56101.36101.191.56
2853832-853832102.384103.58
3820795-82079598.42299.56
4827032-82703299.170100.33
5844405-844405101.253102.43
6823292-82329298.72299.88
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%
112.117661897654277655047655937650827655590.06
212.147654857651947653400.03
单位质量响应值RSD%判断
63217.0963042.830.20数据可信
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%
5min1758041-75804191.01593.194.0391.0193.194.03
2815420-81542097.90497.90
3785674-78567494.33394.33
4756915-75691590.88090.88
5805792-80579296.74896.75
6735176-73517688.27088.27
10min1803659-80365996.49297.262.2496.6497.422.24
2836113-836113100.389100.55
3811117-81111797.38797.54
4810061-81006197.26197.41
5818597-81859798.28698.45
6780923-78092393.76293.91
15min1812512-81251297.55598.321.7397.8798.641.74
2837959-837959100.610100.94
3817788-81778898.18898.51
4827966-82796699.41099.72
5820881-82088198.56098.88
6796268-79626895.60595.91
20min1816911-81691198.08398.731.5198.5699.211.51
2838670-838670100.696101.19
3819183-81918398.35698.84
4833090-833090100.026100.50
5822259-82225998.72599.21
6803708-80370896.49896.96
30min1823808-82380898.91199.291.2199.5599.941.21
2839370-839370100.780101.45
3821241-82124198.60399.25
4839063-839063100.743101.39
5823110-82311098.82799.48
6815210-81521097.87998.50
45min1826126-82612699.19099.461.0299.99100.271.02
2837215-837215100.521101.35
3821443-82144398.62799.44
4840596-840596100.927101.74
5823524-82352498.87799.70
6821534-82153498.63899.42
60min1823622-82362298.88999.400.9899.86100.380.98
2835718-835718100.341101.34
3820664-82066498.53499.51
4840293-840293100.890101.87
5823437-82343798.86799.85
6823619-82361998.88899.84
极限1822344-82234498.73599.370.9799.87100.510.97
2833290-833290100.050101.22
3820166-82016698.47499.61
4840867-840867100.959102.11
5822448-82244898.74899.90
6826521-82652199.237100.35
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%
112.117664627664597664347663957663687664240.01
212.147682687683757683220.01
单位质量响应值RSD%判断
63288.5263288.470.01数据可信
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%
5min1810472-81047297.06694.812.1497.0794.812.14
2775843-77584392.91992.92
3770584-77058492.28992.29
4797338-79733895.49395.49
5809302-80930296.92696.93
6786179-78617994.15794.16
10min1835446-835446100.05799.161.24100.2299.321.24
2815405-81540597.65797.81
3835651-835651100.082100.24
4834994-834994100.003100.16
5831978-83197899.64299.80
6814415-81441597.53897.70
15min1838552-838552100.42999.671.19100.7699.991.19
2821533-82153398.39198.71
3839528-839528100.546100.87
4832992-83299299.763100.09
5841948-841948100.836101.16
6818616-81861698.04198.36
20min1837548-837548100.30999.501.08100.8099.981.08
2821528-82152898.39098.87
3839281-839281100.516101.00
4835535-835535100.068100.56
5832892-83289299.751100.25
6817837-81783797.94898.43
30min1839866-839866100.58699.531.11101.25100.191.11
2822139-82213998.46399.11
3840191-840191100.625101.28
4835198-835198100.027100.69
5830804-83080499.501100.16
6818120-81812097.98298.63
45min1836588-836588100.19499.411.24101.02100.231.24
2821172-82117298.34899.16
3839852-839852100.585101.41
4838102-838102100.375101.20
5830099-83009999.417100.24
6814422-81442297.53998.35
60min1836494-836494100.18399.431.24101.18100.421.24
2820112-82011298.22199.19
3841411-841411100.771101.76
4835251-835251100.034101.03
5832918-83291899.754100.75
6815087-81508797.61998.59
极限1834933-83493399.99699.141.17101.16100.301.17
2818590-81859098.03899.18
3837203-837203100.267101.43
4833730-83373099.852101.01
5828946-82894699.279100.44
6813574-81357497.43898.57
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