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%
111.917537827543187538757542917534977539530.05
211.917550707548007549350.03
单位质量响应值RSD%判断
63304.2063386.650.10数据可信
供试品溶液-2024072721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%
5min1425279-42527950.88848.745.9650.8948.745.96
2383745-38374545.91845.92
3393642-39364247.10247.10
4380609-38060945.54345.54
5437727-43772752.37752.38
6422728-42272850.58250.58
10min1495909-49590959.33957.344.9159.4257.424.91
2455582-45558254.51454.59
3470432-47043256.29156.37
4451516-45151654.02754.10
5509275-50927560.93861.03
6492412-49241258.92159.00
15min1552811-55281166.14863.764.4166.3363.944.41
2508736-50873660.87461.04
3524126-52412662.71562.89
4504933-50493360.41960.58
5559517-55951766.95067.14
6547145-54714565.47065.65
20min1589055-58905570.48568.523.5270.7868.803.53
2550030-55003065.81566.08
3565719-56571967.69267.97
4549696-54969665.77566.04
5594243-59424371.10571.41
6587116-58711670.25370.54
30min1644310-64431077.09675.012.9277.5175.402.92
2606005-60600572.51372.89
3618062-61806273.95674.35
4607850-60785072.73473.11
5641111-64111176.71477.13
6643675-64367577.02077.43
45min1683593-68359381.79780.912.2982.3481.432.30
2660632-66063279.04979.55
3662911-66291179.32279.84
4663921-66392179.44379.94
5690444-69044482.61783.16
6695365-69536583.20583.74
60min1721018-72101886.27584.422.4086.9585.082.40
2688522-68852282.38783.02
3687169-68716982.22582.87
4695567-69556783.23083.86
5717623-71762385.86986.55
6723139-72313986.52987.20
90min1741327-74132788.70587.622.1989.5388.422.20
2717069-71706985.80386.57
3720381-72038186.19986.98
4716462-71646285.73086.50
5750337-75033789.78390.61
6748020-74802089.50690.33
120min1756938-75693890.57390.081.7791.5491.021.78
2739102-73910288.43989.35
3738804-73880488.40389.33
4746856-74685689.36790.28
5766299-76629991.69392.67
6768936-76893692.00992.98
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1782056-78205693.57992.001.7494.7093.101.76
2753335-75333590.14291.20
3752868-75286890.08691.16
4767014-76701491.77992.84
5776447-77644792.90894.04
6781595-78159593.52494.65
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%
111.917544427540897537287549507541247542670.07
211.917529547521607525570.08
单位质量响应值RSD%判断
63330.5663186.990.17数据可信
供试品溶液-2024073021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%
5min1292839-29283935.08844.9415.9035.0944.9415.90
2337021-33702140.38240.38
3463749-46374955.56755.57
4403533-40353348.35248.35
5397849-39784947.67147.67
6355589-35558942.60742.61
10min1370936-37093644.44652.6612.4244.5052.7312.43
2389059-38905946.61846.68
3516007-51600761.82961.92
4471603-47160356.50856.59
5463404-46340455.52655.61
6425709-42570951.00951.08
15min1428634-42863451.35958.729.9151.4958.889.93
2440653-44065352.80052.94
3554120-55412066.39566.59
4521028-52102862.43062.61
5511896-51189661.33661.51
6483991-48399157.99258.15
20min1482545-48254557.81963.637.7758.0463.897.79
2483488-48348857.93258.17
3584364-58436470.01970.33
4558325-55832566.89967.18
5548274-54827465.69565.97
6529067-52906763.39363.65
30min1559103-55910366.99270.535.3067.3170.905.33
2550153-55015365.92066.25
3632152-63215275.74576.17
4607159-60715972.75173.14
5602909-60290972.24172.63
6580438-58043869.54969.91
45min1626114-62611475.02276.843.5675.4577.333.59
2611077-61107773.22073.66
3676717-67671781.08581.63
4652704-65270478.20878.72
5646611-64661177.47877.98
6634632-63463276.04276.52
60min1663576-66357679.51180.502.9680.0681.112.99
2646022-64602277.40777.97
3706368-70636884.63885.32
4675645-67564580.95781.60
5673147-67314780.65781.29
6666303-66630379.83780.44
90min1707200-70720084.73884.372.8085.4285.122.82
2684320-68432081.99682.69
3741393-74139388.83589.66
4698812-69881283.73384.51
5697740-69774083.60484.37
6695415-69541583.32684.06
120min1721291-72129186.42686.202.9487.2587.082.95
2700071-70007183.88384.71
3759928-75992891.05692.03
4709662-70966285.03385.95
5715428-71542885.72386.63
6709805-70980585.05085.92
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1744149-74414989.16587.962.3590.1388.992.36
2721739-72173986.48087.45
3764916-76491691.65392.78
4722177-72217786.53287.59
5726143-72614387.00788.06
6725455-72545586.92587.94
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%
111.917564677549567564677549217554077556440.11
211.917546587554147550360.08
单位质量响应值RSD%判断
63446.1863395.130.06数据可信
供试品溶液-2024073021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%
5min1367797-36779743.95747.4910.0143.9647.5010.01
2352819-35281942.16742.17
3419165-41916550.09750.10
4463952-46395255.44955.45
5386179-38617946.15446.15
6394425-39442547.14047.14
10min1438085-43808552.35855.507.3852.4355.587.39
2430228-43022851.41951.49
3477164-47716457.02857.11
4525163-52516362.76562.86
5451929-45192954.01254.09
6463937-46393755.44855.53
15min1487922-48792258.31461.195.7458.4761.365.74
2484957-48495757.96058.12
3518538-51853861.97362.15
4564637-56463767.48367.68
5499356-49935659.68159.85
6516494-51649461.72961.90
20min1530374-53037463.38865.954.8363.6566.224.84
2526771-52677162.95763.21
3553900-55390066.20066.48
4599706-59970671.67471.98
5541239-54123964.68664.95
6558897-55889766.79767.07
30min1593043-59304370.87872.423.4171.2472.803.43
2590179-59017970.53570.89
3598660-59866071.54971.94
4644638-64463877.04477.47
5595545-59554571.17771.55
6613749-61374973.35273.74
45min1649585-64958577.63578.332.8078.1278.842.82
2641576-64157676.67877.15
3643848-64384876.95077.46
4687695-68769582.19082.75
5643065-64306576.85677.35
6666601-66660179.66980.18
60min1684718-68471881.83481.792.6082.4582.432.62
2671621-67162180.26980.87
3670998-67099880.19580.83
4713445-71344585.26885.96
5668759-66875979.92780.55
6696640-69664083.25983.90
90min1724443-72444386.58285.562.4887.3386.332.49
2706927-70692784.48985.23
3701826-70182683.87984.65
4742553-74255388.74689.58
5695098-69509883.07583.83
6724603-72460386.60187.38
120min1736848-73684888.06587.192.4588.9688.102.46
2724131-72413186.54587.42
3713037-71303785.21986.13
4754138-75413890.13191.12
5707406-70740684.54685.44
6741650-74165088.63989.56
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1749171-74917189.53789.262.2190.5890.322.22
2743995-74399588.91989.94
3731930-73193087.47788.53
4769677-76967791.98893.12
5726304-72630486.80487.84
6760213-76021390.85791.93
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