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%
112.113828943824903828783829613829643828370.06
212.143817463805433811440.23
单位质量响应值RSD%判断
31613.2931395.720.49数据可信
供试品溶液-BXJVV61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%
5min1358545-35854586.26484.903.1986.2684.903.19
2365489-36548987.93587.93
3336840-33684081.04281.04
4342735-34273582.46082.46
5361773-36177387.04187.04
6351990-35199084.68784.69
10min1385789-38578992.81993.271.8692.9693.411.86
2395574-39557495.17395.32
3380844-38084491.62991.76
4378393-37839391.03991.18
5390450-39045093.94094.09
6394822-39482294.99295.13
15min1389501-38950193.71294.721.9794.0195.021.97
2402375-40237596.80997.11
3384748-38474892.56892.86
4386237-38623792.92793.22
5399361-39936196.08496.39
6399832-39983296.19896.50
20min1395856-39585695.24195.521.8995.7095.981.89
2403476-40347697.07497.54
3389735-38973593.76894.21
4386806-38680693.06493.51
5404883-40488397.41397.87
6401324-40132496.55797.02
30min1396362-39636295.36395.971.9395.9896.591.93
2405072-40507297.45898.09
3386370-38637092.95993.56
4395449-39544995.14395.74
5403497-40349797.07997.70
6406601-40660197.82698.45
45min1389565-38956593.72796.401.6594.5097.171.65
2404560-40456097.33598.13
3402157-40215796.75797.51
4397119-39711995.54596.30
5401971-40197196.71297.50
6408636-40863698.31699.10
60min1395487-39548795.15296.091.9396.0897.021.93
2406111-40611197.70898.66
3388838-38883893.55294.47
4394845-39484594.99895.91
5401727-40172796.65497.60
6409242-40924298.46299.41
90min1399516-39951696.12296.051.6697.2197.141.66
2403016-40301696.96498.08
3389085-38908593.61294.68
4395552-39555295.16896.24
5399400-39940096.09497.20
6408619-40861998.31299.42
120min1-0.0000.00-1.251.261.87
2-0.0001.28
3-0.0001.23
4-0.0001.23
5-0.0001.27
6-0.0001.28
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1-0.0000.00-1.251.261.87
2-0.0001.28
3-0.0001.23
4-0.0001.23
5-0.0001.27
6-0.0001.28
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%
112.113809623813593808623810993810563810680.05
212.143825203827773826480.05
单位质量响应值RSD%判断
31467.2231519.600.12数据可信
供试品溶液-BXJVV61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%
5min186538-8653820.82820.464.4220.8320.464.42
281527-8152719.62219.62
380535-8053519.38319.38
489952-8995221.64921.65
588038-8803821.18921.19
683497-8349720.09620.10
10min1144457-14445734.76733.462.6934.8033.502.68
2140953-14095333.92433.96
3134554-13455432.38432.42
4137260-13726033.03533.07
5140963-14096333.92733.96
6135961-13596132.72332.76
15min1173663-17366341.79740.282.8941.8940.372.89
2170709-17070941.08641.17
3165316-16531639.78839.87
4164702-16470239.64039.73
5169466-16946640.78740.88
6160323-16032338.58638.67
20min1196597-19659747.31645.243.0947.4845.393.09
2190012-19001245.73245.89
3186096-18609644.78944.94
4183705-18370544.21444.37
5191007-19100745.97146.13
6180326-18032643.40043.55
30min1206458-20645849.69051.523.1249.9351.753.11
2220973-22097353.18353.42
3216952-21695252.21552.44
4212528-21252851.15151.38
5220997-22099753.18953.43
6206431-20643149.68349.91
45min1259285-25928562.40460.133.0462.7360.443.04
2254658-25465861.29061.61
3251493-25149360.52960.84
4242892-24289258.45958.77
5251788-25178860.60060.92
6238854-23885457.48757.79
60min1284397-28439768.44866.092.9268.8866.512.91
2278156-27815666.94667.37
3278192-27819266.95467.37
4267987-26798764.49864.91
5276479-27647966.54266.97
6262330-26233063.13763.54
90min1316146-31614676.08974.053.4376.6374.583.42
2309500-30950074.49075.03
3311920-31192075.07275.60
4300742-30074272.38272.90
5317836-31783676.49677.03
6290017-29001769.80070.31
120min1337873-33787381.31878.732.6581.9979.382.65
2330951-33095179.65280.31
3332024-33202479.91180.56
4321106-32110677.28377.92
5327236-32723678.75879.42
6313609-31360975.47876.10
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1363478-36347887.48185.762.0788.2986.542.06
2356183-35618385.72586.52
3363162-36316287.40588.19
4345921-34592183.25584.03
5359974-35997486.63787.43
6349259-34925984.05984.81
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