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%
111.973793333787963807303805063800213798770.22
211.993801843805663803750.08
单位质量响应值RSD%判断
31735.7631724.350.03数据可信
供试品溶液-2024072521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%
5min1344948-34494882.40287.096.3482.4087.096.34
2402727-40272796.20496.20
3368175-36817587.95087.95
4377876-37787690.26890.27
5344601-34460182.31982.32
6349126-34912683.40083.40
10min1378375-37837590.38793.093.9390.5293.233.93
2410009-41000997.94498.10
3392976-39297693.87594.02
4398495-39849595.19395.34
5366524-36652487.55687.69
6391772-39177293.58793.73
15min1385479-38547992.08494.253.3192.3794.553.31
2411821-41182198.37798.70
3396113-39611394.62494.93
4401261-40126195.85496.16
5374364-37436489.42989.71
6398200-39820095.12395.42
20min1392425-39242593.74395.372.6494.1895.832.65
2414140-41414098.93199.42
3401149-40114995.82796.29
4402466-40246696.14296.61
5383071-38307191.50991.94
6402252-40225296.09196.54
30min1398496-39849695.19396.582.0495.7997.202.05
2415649-41564999.29199.94
3404868-40486896.71697.34
4405219-40521996.80097.43
5392120-39212093.67094.26
6409411-40941197.80198.41
45min1402535-40253596.15897.151.2796.9197.921.29
2415604-41560499.280100.10
3408484-40848497.57998.36
4406861-40686197.19297.98
5401151-40115195.82896.57
6405366-40536696.83597.61
60min1403796-40379696.46097.330.9897.3898.270.99
2414530-41453099.024100.01
3409164-40916497.74298.69
4406533-40653397.11398.07
5404320-40432096.58597.49
6406238-40623897.04397.98
极限1404082-40408296.52897.310.9697.6198.410.97
2413660-41366098.81699.96
3410489-41048998.05899.17
4404422-40442296.60997.72
5405082-40508296.76797.83
6406392-40639297.08098.18
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%
111.973805993806763795363787533788773796880.25
211.993794273788413791340.11
单位质量响应值RSD%判断
31719.9731620.850.23数据可信
供试品溶液-2024072521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%
5min1309814-30981474.14980.7612.6574.1580.7612.65
2370345-37034588.63688.64
3263024-26302462.95062.95
4365341-36534187.43887.44
5364817-36481787.31387.31
6351215-35121584.05784.06
10min1357958-35795885.67189.918.6585.7990.048.66
2391572-39157293.71693.86
3317838-31783876.06976.17
4406631-40663197.32097.47
5389302-38930293.17393.32
6390596-39059693.48293.62
15min1366763-36676387.77892.437.0388.0492.727.04
2395697-39569794.70395.01
3341485-34148581.72881.96
4416147-41614799.59799.91
5396825-39682594.97395.27
6400313-40031395.80896.10
20min1378649-37864990.62394.205.6391.0494.645.64
2399167-39916795.53496.00
3357948-35794885.66986.04
4421417-421417100.859101.33
5401260-40126096.03596.49
6403089-40308996.47296.93
30min1388956-38895693.09096.024.1493.6596.614.16
2400088-40008895.75496.38
3378347-37834790.55191.06
4426609-426609102.101102.74
5407418-40741897.50898.13
6405690-40569097.09597.71
45min1404073-40407396.70897.703.4097.4398.463.42
2400907-40090795.95096.73
3395275-39527594.60295.26
4435089-435089104.131104.94
5407241-40724197.46698.25
6406818-40681897.36598.14
60min1400057-40005795.74797.552.8596.6398.472.85
2398808-39880895.44896.39
3403666-40366696.61097.43
4430304-430304102.986103.97
5407491-40749197.52698.47
6405330-40533097.00997.95
极限1401107-40110795.99897.962.7697.0499.042.77
2398625-39862595.40496.50
3406278-40627897.23598.22
4430230-430230102.968104.13
5407897-40789797.62398.73
6411682-41168298.52999.63
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%
111.973799503792093798393793503794603795620.09
211.993804423801313802860.06
单位质量响应值RSD%判断
31709.4431716.930.02数据可信
供试品溶液-2024072521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%
5min1401712-40171296.01395.664.8396.0195.664.83
2411339-41133998.31498.31
3410750-41075098.17398.17
4396674-39667494.80994.81
5363737-36373786.93686.94
6417100-41710099.69199.69
10min1411893-41189398.44697.782.5098.6197.942.51
2416823-41682399.62499.79
3412777-41277798.65798.82
4400943-40094395.82995.99
5392727-39272793.86594.01
6419455-419455100.254100.42
15min1414691-41469199.11598.122.3099.4498.442.30
2416824-41682499.62599.95
3413400-41340098.80699.13
4401565-40156595.97896.30
5396351-39635194.73195.03
6420372-420372100.473100.81
20min1413160-41316098.74998.141.7599.2498.631.75
2416950-41695099.655100.15
3412043-41204398.48298.97
4402895-40289596.29696.77
5400856-40085695.80896.27
6417869-41786999.874100.38
30min1417111-41711199.69398.471.72100.3599.121.73
2417385-41738599.759100.42
3412718-41271898.64399.30
4401460-40146095.95396.59
5405187-40518796.84397.46
6418064-41806499.921100.59
45min1417672-41767299.82798.651.31100.6599.471.31
2416274-41627499.493100.32
3411701-41170198.40099.22
4403259-40325996.38397.18
5411089-41108998.25499.03
6416572-41657299.564100.40
60min1418607-418607100.05198.701.43101.0499.681.43
2416471-41647199.540100.53
3411227-41122798.28799.27
4402483-40248396.19797.16
5412038-41203898.48199.42
6416958-41695899.657100.66
极限1417594-41759499.80998.411.46100.9699.551.46
2414401-41440199.046100.21
3410038-41003898.00399.15
4400754-40075495.78496.90
5412100-41210098.49699.60
6415484-41548499.304100.47
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%
111.973806413802503804083792933802623801710.14
211.993803473809243806360.11
单位质量响应值RSD%判断
31760.3231746.120.04数据可信
供试品溶液-2024072521批-pH0.95
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1240290-24029057.35975.6635.7957.3675.6635.79
2121722-12172229.05629.06
3374428-37442889.37989.38
4413959-41395998.81598.82
5356480-35648085.09585.09
6394746-39474694.22994.23
10min1350773-35077383.73290.7413.4083.8390.8713.43
2290775-29077569.41069.46
3411594-41159498.25198.40
4423627-423627101.123101.29
5390266-39026693.15993.30
6413809-41380998.77998.94
15min1380126-38012690.73994.148.3590.9794.428.39
2335095-33509579.99080.15
3413768-41376898.77099.08
4422928-422928100.956101.29
5397804-39780494.95995.26
6416487-41648799.41999.74
20min1386876-38687692.35095.376.1292.7495.806.17
2356622-35662285.12885.43
3413447-41344798.69399.17
4422230-422230100.790101.29
5402162-40216295.99996.45
6415830-41583099.26299.75
30min1397595-39759594.90997.134.0195.4597.724.07
2379393-37939390.56491.00
3414431-41443198.92899.57
4425278-425278101.517102.19
5408405-40840597.48998.10
6416206-41620699.352100.00
45min1416349-41634999.38699.341.04100.08100.091.00
2420637-420637100.409101.00
3415282-41528299.13199.94
4420737-420737100.433101.27
5409166-40916697.67198.45
6414737-41473799.00199.82
60min1407206-40720697.20398.061.5998.0798.981.67
2400902-40090295.69896.46
3413692-41369298.75199.72
4420276-420276100.323101.33
5410074-41007497.88898.83
6412616-41261698.49599.48
极限1408150-40815097.42997.981.3898.4599.061.45
2401976-40197695.95596.87
3414172-41417298.866100.00
4417571-41757199.677100.85
5407556-40755697.28798.39
6413305-41330598.65999.81
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