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%
1 12.103910883910433907043910163904453908590.08
2 12.013907543910943909240.07
单位质量响应值RSD%判断
32302.4032549.880.54数据可信
供试品溶液-6021401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%
5min1208072-20807248.43453.388.6548.4353.388.65
2241538-24153856.22456.22
3247939-24793957.71457.71
4204146-20414647.52047.52
5248606-24860657.86957.87
6225677-22567752.53252.53
10min1263305-26330561.29164.846.9861.3764.926.98
2287760-28776066.98467.08
3298167-29816769.40669.50
4250995-25099558.42658.50
5298327-29832769.44369.54
6272688-27268863.47563.56
15min1293720-29372068.37171.896.5168.5572.086.51
2325668-32566875.80876.01
3328184-32818476.39376.61
4280183-28018365.22065.40
5324435-32443575.52175.73
6300776-30077670.01370.21
20min1308328-30832871.77175.124.9072.0775.444.91
2333953-33395377.73678.07
3338187-33818778.72279.06
4302004-30200470.29970.58
5337185-33718578.48978.83
6316701-31670173.72074.03
30min1338698-33869878.84180.812.8179.2681.252.83
2352132-35213281.96882.43
3355305-35530582.70683.18
4333577-33357777.64978.05
5358198-35819883.38083.85
6344948-34494880.29680.73
45min1364969-36496984.95686.002.1585.5086.582.17
2373750-37375087.00087.60
3374154-37415487.09487.70
4357789-35778983.28583.82
5379817-37981788.41289.02
6366278-36627885.26185.83
60min1378855-37885588.18888.991.4088.8889.711.42
2383825-38382589.34590.09
3386331-38633189.92990.68
4373026-37302686.83187.50
5385643-38564389.76890.52
6386166-38616689.89090.60
90min1387917-38791790.29891.051.3191.1391.921.33
2399781-39978193.05993.95
3389442-38944290.65391.56
4385877-38587789.82390.64
5394645-39464591.86492.77
6389340-38934090.62991.49
120min1401206-40120693.39192.690.8294.3893.710.84
2400073-40007393.12794.17
3399960-39996093.10194.16
4393781-39378191.66392.63
5399811-39981193.06694.12
6394276-39427691.77892.79
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1405423-40542394.37393.461.0195.5294.631.01
2405246-40524694.33195.53
3396135-39613592.21193.42
4397819-39781992.60393.72
5404316-40431694.11595.33
6399955-39995593.10094.26
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%
1 12.103907123906693913763906063906773908080.09
2 12.013907903904533906220.07
单位质量响应值RSD%判断
32298.1832524.730.50数据可信
供试品溶液-6021401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%
5min1256685-25668559.77756.426.3259.7856.426.33
2254711-25471159.31759.32
3241042-24104256.13456.13
4217685-21768550.69550.69
5251844-25184458.65058.65
6231703-23170353.95953.96
10min1303710-30371070.72867.614.7570.8367.704.76
2302301-30230170.40070.50
3290081-29008167.55467.65
4265748-26574861.88861.97
5293407-29340768.32968.43
6286676-28667666.76166.85
15min1328491-32849176.49973.643.8376.7273.853.84
2328130-32813076.41576.63
3315437-31543773.45973.67
4298080-29808069.41769.60
5320485-32048574.63574.85
6306663-30666371.41671.62
20min1343631-34363180.02577.722.9680.3778.052.97
2344333-34433380.18980.53
3331894-33189477.29277.62
4320222-32022274.57474.88
5337343-33734378.56178.90
6324980-32498075.68276.00
30min1364320-36432084.84384.172.5785.3284.632.57
2375464-37546487.43887.92
3356650-35665083.05783.51
4347348-34734880.89181.32
5362768-36276884.48284.95
6361965-36196584.29584.74
45min1375562-37556287.46187.761.8888.0888.361.88
2386160-38616089.92990.55
3376209-37620987.61288.21
4370067-37006786.18186.74
5384168-38416889.46590.07
6369026-36902685.93986.53
60min1402810-40281093.80791.722.4094.5792.472.41
2402149-40214993.65394.43
3397507-39750792.57293.31
4384518-38451889.54790.25
5396166-39616692.25993.02
6380020-38002088.49989.23
90min1394378-39437891.84392.681.3492.7693.581.34
2404533-40453394.20895.14
3391669-39166991.21292.11
4397893-39789392.66293.52
5404119-40411994.11295.02
6395153-39515392.02492.90
120min1402602-40260293.75893.871.6394.8394.931.63
2406791-40679194.73495.82
3400544-40054493.27994.33
4402034-40203493.62694.64
5413088-41308896.20097.27
6393502-39350291.63992.67
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1404345-40434594.16494.461.3295.4095.671.33
2411433-41143395.81597.06
3403620-40362093.99595.20
4404526-40452694.20695.37
5411982-41198295.94397.17
6397772-39777292.63393.82
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%
1 12.103910653912423910873915083911323912070.05
2 12.013902033903783902900.04
单位质量响应值RSD%判断
32331.1632497.090.37数据可信
供试品溶液-6021401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%
5min1217505-21750550.64849.9215.8350.6549.9215.82
2241319-24131956.19456.19
3252760-25276058.85858.86
4207200-20720048.24948.25
5155311-15531136.16636.17
6212288-21228849.43349.43
10min1262788-26278861.19359.7911.5761.2859.8711.57
2283241-28324165.95666.05
3290534-29053467.65467.75
4236726-23672655.12455.20
5210628-21062849.04749.11
6256584-25658459.74859.83
15min1289293-28929367.36566.868.0167.5567.048.03
2308439-30843971.82372.03
3311794-31179472.60472.82
4280267-28026765.26365.44
5248095-24809557.77157.91
6284783-28478366.31566.50
20min1317893-31789374.02571.957.1574.3272.247.17
2328843-32884376.57476.90
3330287-33028776.91177.24
4302765-30276570.50270.78
5271126-27112663.13463.37
6302964-30296470.54870.84
30min1353408-35340882.29579.695.3582.7280.105.37
2357585-35758583.26783.72
3354463-35446382.54083.00
4338404-33840478.80179.20
5308374-30837471.80872.15
6340997-34099779.40579.81
45min1383835-38383589.38085.794.9289.9486.344.94
2385086-38508689.67190.26
3368262-36826285.75486.35
4366252-36625285.28685.82
5335123-33512378.03778.50
6372007-37200786.62687.17
60min1399468-39946893.02089.774.9693.7390.464.98
2401339-40133993.45694.20
3385821-38582189.84290.58
4388763-38876390.52791.20
5348660-34866081.18981.78
6389098-38909890.60591.29
90min1416626-41662697.01692.915.0197.8893.755.02
2414414-41441496.50197.40
3392815-39281591.47192.36
4402709-40270993.77594.60
5362190-36219084.34085.07
6405172-40517294.34895.19
120min1421704-42170498.19895.205.8199.2296.195.81
2423842-42384298.69699.75
3397958-39795892.66993.71
4412978-41297896.16697.15
5366079-36607985.24586.11
6430344-430344100.210101.21
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1425399-42539999.05995.694.81100.2596.844.81
2428428-42842899.764100.98
3392999-39299991.51492.71
4416574-41657497.00498.14
5380024-38002488.49289.50
6422069-42206998.28399.45
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%
1 12.103908713911913917543913633910793912520.09
2 12.013916813922593919700.11
单位质量响应值RSD%判断
32334.8832636.970.66数据可信
供试品溶液-6021401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%
5min1213289-21328949.55749.7413.4649.5649.7413.47
2227003-22700352.74452.74
3241352-24135256.07856.08
4219989-21998951.11451.11
5158427-15842736.81036.81
6224478-22447852.15752.16
10min1253211-25321158.83359.727.3158.9259.807.32
2270798-27079862.92063.01
3279690-27969064.98665.08
4255566-25556659.38159.47
5224731-22473152.21652.28
6258087-25808759.96660.05
15min1276720-27672064.29665.725.9564.4865.905.96
2293354-29335468.16168.35
3303326-30332670.47870.68
4278744-27874464.76664.95
5254967-25496759.24159.39
6290068-29006867.39767.58
20min1296647-29664768.92671.094.7069.2171.384.72
2312138-31213872.52572.83
3327054-32705475.99176.31
4306070-30607071.11571.41
5284684-28468466.14666.39
6309092-30909271.81772.12
30min1323225-32322575.10178.893.8375.5079.303.84
2354918-35491882.46582.89
3353982-35398282.24782.69
4337470-33747078.41178.82
5328199-32819976.25776.61
6339498-33949878.88279.30
45min1351203-35120381.60284.822.3882.1385.362.39
2369554-36955485.86686.43
3376963-37696387.58788.17
4360754-36075483.82184.36
5365012-36501284.81085.29
6366721-36672185.20785.76
60min1363222-36322284.39488.322.5885.0689.002.57
2383210-38321089.03889.75
3391542-39154290.97491.70
4375110-37511087.15687.84
5384185-38418589.26589.89
6383461-38346189.09789.79
90min1381591-38159188.66291.852.3689.4792.682.35
2397386-39738692.33293.19
3406190-40619094.37895.26
4387149-38714989.95490.78
5402651-40265193.55694.33
6396889-39688992.21793.06
120min1383448-38344889.09492.952.4790.0593.942.46
2399001-39900192.70893.72
3408859-40885994.99896.04
4395220-39522091.82992.81
5409533-40953395.15596.09
6404314-40431493.94294.94
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1402899-40289993.61395.091.5994.7196.221.58
2407018-40701894.57095.73
3416255-41625596.71697.91
4402507-40250793.52294.65
5417593-41759397.02798.12
6409153-40915395.06696.22
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