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D23106010771对照品来源中检所对照品使用方法直接使用
对照品含量(%)90.12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%
112.103882533885033882593886513882983883930.05
212.133880323882003881160.04
单位质量响应值RSD%判断
32098.6031996.370.23数据可信
供试品溶液-6031101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%
5min1208144-20814449.02348.938.4749.0248.938.47
2208033-20803348.99749.00
3182945-18294543.08843.09
4236602-23660255.72555.73
5211967-21196749.92349.92
6198764-19876446.81446.81
10min1251581-25158159.25358.165.7859.3358.245.78
2246490-24649058.05458.14
3227589-22758953.60353.67
4269723-26972363.52663.62
5249105-24910558.67058.75
6237152-23715255.85555.93
15min1278902-27890265.68864.714.8365.8764.894.83
2274744-27474464.70964.89
3255829-25582960.25460.41
4296147-29614769.75069.95
5274873-27487364.73964.92
6268104-26810463.14563.32
20min1297011-29701169.95370.423.9770.2470.713.98
2299447-29944770.52770.81
3284443-28444366.99367.25
4319854-31985475.33375.65
5301184-30118470.93671.22
6292107-29210768.79869.07
30min1330564-33056477.85677.873.9778.2678.273.97
2336615-33661579.28179.68
3321200-32120075.65076.02
4349366-34936682.28482.72
5334533-33453378.79079.20
6311453-31145373.35473.75
45min1361804-36180485.21385.062.4485.7585.592.45
2367594-36759486.57787.11
3357929-35792984.30184.80
4373546-37354687.97988.56
5357791-35779184.26884.81
6348144-34814481.99682.51
60min1378376-37837689.11688.832.9589.7989.512.94
2384018-38401890.44591.13
3383154-38315490.24290.88
4388339-38833991.46392.19
5371273-37127387.44388.12
6357879-35787984.28984.94
90min1391510-39151092.21092.583.1193.0493.403.10
2399391-39939194.06694.90
3404498-40449895.26996.06
4401020-40102094.45095.33
5391542-39154292.21793.04
6370540-37054087.27188.06
120min1394289-39428992.86493.253.0593.8494.233.04
2397473-39747393.61494.60
3409404-40940496.42497.37
4406971-40697195.85196.89
5391536-39153692.21693.19
6375942-37594288.54389.48
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1409144-40914496.36395.363.1997.5096.493.16
2414211-41421197.55698.70
3418606-41860698.59199.70
4403770-40377095.09796.29
5401582-40158294.58295.71
6381991-38199189.96891.05
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D23106010771对照品来源中检所对照品使用方法直接使用
对照品含量(%)90.12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%
112.103877753878253877033882583883293879780.08
212.133883213871893877550.21
单位质量响应值RSD%判断
32064.3031966.610.22数据可信
供试品溶液-6031102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%
5min1185949-18594943.83943.438.0943.8443.438.09
2170620-17062040.22540.23
3208349-20834949.12049.12
4166673-16667339.29539.29
5189701-18970144.72444.72
6184071-18407143.39643.40
10min1229213-22921354.03954.076.3354.1154.156.33
2215357-21535750.77250.84
3249065-24906558.71958.80
4211027-21102749.75149.82
5240823-24082356.77656.85
6230703-23070354.39054.46
15min1261696-26169661.69762.255.4661.8662.415.47
2251830-25183059.37159.52
3283205-28320566.76866.95
4245219-24521957.81357.96
5276711-27671165.23765.41
6265527-26552762.60062.76
20min1285518-28551867.31367.754.7567.5868.024.76
2276810-27681065.26065.51
3304417-30441771.76972.06
4268630-26863063.33263.58
5300484-30048470.84271.12
6288446-28844668.00468.27
30min1323093-32309376.17275.794.0576.5576.174.06
2316107-31610774.52574.88
3334252-33425278.80379.21
4299356-29935670.57670.93
5334257-33425778.80479.20
6321724-32172475.84976.23
45min1345964-34596481.56481.743.3682.0782.243.37
2343247-34324780.92481.41
3355670-35567083.85284.39
4326398-32639876.95177.42
5359609-35960984.78185.31
6349252-34925282.33982.85
60min1361411-36141185.20685.043.0085.8585.683.01
2360345-36034584.95585.57
3369506-36950687.11487.80
4340911-34091180.37380.97
5371343-37134387.54788.22
6360665-36066585.03085.67
90min1373609-37360988.08288.102.7988.8688.882.81
2371647-37164787.61988.38
3382600-38260090.20191.03
4354480-35448083.57284.30
5382471-38247190.17190.99
6377268-37726888.94489.73
120min1379527-37952789.47789.342.7090.4190.262.71
2379106-37910689.37890.28
3388455-38845591.58292.56
4359480-35948084.75185.62
5385658-38565890.92291.89
6381322-38132289.90090.83
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1390443-39044392.05092.082.4393.1393.162.44
2390360-39036092.03193.09
3400791-40079194.49095.62
4372879-37287987.91088.92
5393916-39391692.86993.99
6394940-39494093.11194.19
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D23106010771对照品来源中检所对照品使用方法直接使用
对照品含量(%)90.12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%
112.103881993882043887633880653884873883440.08
212.133881703878323880010.07
单位质量响应值RSD%判断
32094.5531986.890.24数据可信
供试品溶液-6031103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%
5min1196707-19670746.33939.4826.2046.3439.4826.20
2153248-15324836.10136.10
3175820-17582041.41841.42
4212680-21268050.10250.10
587925-8792520.71320.71
6179146-17914642.20242.20
10min1238331-23833156.14452.7410.8756.2252.8010.89
2201996-20199647.58547.64
3224060-22406052.78352.85
4256425-25642560.40760.49
5190119-19011944.78744.82
6232236-23223654.70954.78
15min1272932-27293264.29561.127.4364.4761.287.46
2242279-24227957.07457.21
3257843-25784360.74160.90
4285549-28554967.26867.45
5233580-23358055.02555.13
6264587-26458762.33062.49
20min1296507-29650769.84967.525.6370.1367.785.66
2270421-27042163.70463.94
3284580-28458067.03967.30
4309764-30976472.97273.27
5267161-26716162.93663.14
6291275-29127568.61768.88
30min1326609-32660976.94075.524.0977.3375.894.12
2305069-30506971.86672.21
3315619-31561974.35174.72
4338943-33894379.84680.26
5308354-30835472.64072.95
6329003-32900377.50477.88
45min1350903-35090382.66382.003.1783.1982.503.20
2335311-33531178.99079.45
3341728-34172880.50281.00
4363527-36352785.63786.19
5339698-33969880.02480.45
6357425-35742584.20084.71
60min1363896-36389685.72485.272.2486.3885.902.28
2353658-35365883.31283.90
3356423-35642383.96484.59
4375688-37568888.50289.20
5356960-35696084.09084.65
6365282-36528286.05186.70
90min1374370-37437088.19288.481.9288.9989.251.95
2368957-36895786.91687.65
3370126-37012687.19287.96
4386860-38686091.13491.98
5371431-37143187.49988.20
6381776-38177689.93690.73
120min1382657-38265790.14490.202.1191.0991.122.13
2375609-37560988.48389.36
3374522-37452288.22789.14
4392525-39252592.46893.46
5379446-37944689.38790.23
6392725-39272592.51593.46
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1391716-39171692.27892.431.5593.3893.501.57
2383162-38316290.26391.29
3389340-38934091.71892.78
4399601-39960194.13595.28
5391963-39196392.33693.33
6398466-39846693.86894.96
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