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%
112.303926883927033931183916983926643925740.14
212.253905013907993906500.06
单位质量响应值RSD%判断
31916.5931889.800.06数据可信
供试品溶液-24062601YD1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%
5min1223392-22339253.07553.1914.2553.0753.1914.25
2166630-16663039.58939.59
3254441-25444160.45260.45
4220290-22029052.33852.34
5253126-25312660.13960.14
6225297-22529753.52753.53
10min1251750-25175059.81260.2510.9959.9060.3410.99
2204132-20413248.49948.56
3281718-28171866.93267.03
4251528-25152859.75959.85
5278725-27872566.22166.32
6253640-25364060.26160.35
15min1275471-27547165.44865.7311.2065.6465.9211.20
2219769-21976952.21452.36
3306246-30624672.76072.97
4281391-28139166.85467.04
5302268-30226871.81572.03
6274835-27483565.29765.49
20min1298482-29848270.91570.779.1971.2171.079.20
2246507-24650758.56758.80
3323169-32316976.78077.11
4301409-30140971.61071.91
5319087-31908775.81076.14
6298671-29867170.96071.26
30min1330851-33085178.60577.467.1879.0277.887.20
2282678-28267867.16067.49
3349905-34990583.13283.59
4329346-32934678.24878.67
5341350-34135081.10081.56
6322121-32212176.53176.95
45min1348377-34837782.76983.045.3083.3283.595.32
2317971-31797175.54575.99
3372749-37274988.56089.16
4346431-34643182.30782.86
5362313-36231386.08086.67
6349374-34937483.00683.55
60min1362377-36237786.09686.004.1186.7886.684.15
2337364-33736480.15380.72
3380290-38029090.35191.10
4363618-36361886.39087.08
5372817-37281788.57689.31
6355320-35532084.41985.10
90min1374775-37477589.04189.993.2389.8790.823.26
2365742-36574286.89587.60
3396460-39646094.19395.09
4376477-37647789.44690.27
5390520-39052092.78293.66
6368611-36861187.57788.40
120min1386779-38677991.89392.402.0992.8793.382.13
2380319-38031990.35891.21
3403842-40384295.94797.00
4387246-38724692.00492.98
5390906-39090692.87493.91
6384385-38438591.32492.29
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1380226-38022690.33690.892.8591.4792.022.88
2374494-37449488.97489.97
3402609-40260995.65496.87
4380329-38032990.36191.49
5385448-38544891.57792.77
6372248-37224888.44189.56
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%
112.303909893912563909883917463922473914450.14
212.253899963889843894900.19
单位质量响应值RSD%判断
31824.8031795.100.07数据可信
供试品溶液-24062601YD2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%
5min1223517-22351753.26040.3036.4853.2640.3036.49
2212032-21203250.52350.52
377027-7702718.35418.35
4176373-17637342.02742.03
5109883-10988326.18326.18
6215843-21584351.43251.43
10min1253419-25341960.38548.2031.7360.4748.2731.74
2248264-24826459.15759.24
396106-9610622.90022.93
4213359-21335950.84050.91
5154037-15403736.70436.75
6248607-24860759.23959.32
15min1283042-28304267.44455.8527.4767.6356.0027.48
2276738-27673865.94266.12
3125022-12502229.79029.86
4252615-25261560.19460.35
5188273-18827344.86244.97
6280669-28066966.87867.06
20min1303806-30380672.39262.3521.6272.6962.5921.66
2295828-29582870.49070.78
3164206-16420639.12739.25
4279380-27938066.57166.83
5223178-22317853.17953.36
6303634-30363472.35172.65
30min1332449-33244979.21771.6214.5079.6471.9714.57
2325579-32557977.58077.99
3226154-22615453.88854.07
4316883-31688375.50875.87
5269246-26924664.15664.42
6333195-33319579.39479.81
45min1356761-35676185.01079.579.2685.5680.039.35
2351042-35104283.64784.19
3282112-28211267.22267.50
4345493-34549382.32582.82
5310176-31017673.90974.28
6357912-35791285.28485.83
60min1375090-37509089.37784.427.0890.0785.017.18
2367376-36737687.53988.22
3315640-31564075.21175.60
4356067-35606784.84485.47
5332973-33297379.34179.84
6378501-37850190.19090.88
90min1382378-38237891.11488.763.5791.9689.503.69
2380219-38021990.59991.42
3355877-35587784.79985.31
4371989-37198988.63889.41
5357272-35727285.13185.76
6387243-38724392.27393.11
120min1389476-38947692.80591.042.7693.8091.932.88
2390050-39005092.94293.92
3368524-36852487.81388.46
4377659-37765989.98990.91
5372683-37268388.80489.58
6394097-39409793.90694.90
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1392397-39239793.50192.051.6994.6593.091.79
2391095-39109593.19194.32
3379843-37984390.51091.31
4378982-37898290.30591.37
5382703-38270391.19192.11
6392876-39287693.61594.77
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