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%
111.963747353749433752013751803744553749030.09
2 12.003746493744683745580.04
单位质量响应值RSD%判断
31346.4031213.170.31数据可信
供试品溶液-6021201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%
5min1270772-27077265.33852.4827.6265.3452.4827.62
2107308-10730825.89425.89
3252832-25283261.00961.01
4253868-25386861.25961.26
5223869-22386954.02154.02
6196366-19636647.38447.38
10min1300488-30048872.50962.4519.5272.6262.5419.54
2169450-16945040.88940.93
3292746-29274670.64170.74
4291873-29187370.43070.53
5266625-26662564.33864.43
6231743-23174355.92156.00
15min1320437-32043777.32369.4014.3977.5569.6014.41
2215004-21500451.88151.99
3315395-31539576.10676.33
4316182-31618276.29676.52
5294899-29489971.16071.36
6263794-26379463.65563.83
20min1342754-34275482.70875.3811.5983.0775.6911.62
2250362-25036260.41360.61
3333114-33311480.38280.73
4339371-33937181.89282.24
5320057-32005777.23177.55
6288761-28876169.67969.96
30min1366727-36672788.49382.927.8888.9983.357.92
2296678-29667871.59071.89
3357897-35789786.36286.84
4365058-36505888.09088.57
5347292-34729283.80384.25
6328041-32804179.15879.55
45min1378629-37862991.36588.635.3892.0189.205.44
2331867-33186780.08180.50
3379349-37934991.53992.16
4385430-38543093.00693.64
5370253-37025389.34489.93
6358226-35822686.44186.97
60min1391507-39150794.47291.833.8095.2792.553.87
2354886-35488685.63586.19
3389078-38907893.88694.66
4392289-39228994.66195.45
5382288-38228892.24892.98
6373328-37332890.08690.76
90min1394726-39472695.24993.883.1096.2094.753.17
2369813-36981389.23789.93
3395851-39585195.52196.45
4404496-40449697.60798.55
5384797-38479792.85393.74
6384672-38467292.82393.64
120min1401471-40147196.87795.352.7897.9996.382.84
2379241-37924191.51292.36
3398055-39805596.05297.14
4410987-41098799.173100.28
5388711-38871193.79894.84
6392368-39236894.68095.66
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1406284-40628498.03896.502.4899.3197.692.55
2387190-38719093.43194.43
3401518-40151896.88898.14
4414311-41431199.975101.25
5398935-39893596.26597.46
6391247-39124794.41095.54
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%
111.963744753744533740423740633744573742980.06
2 12.003744643738953741800.11
单位质量响应值RSD%判断
31295.8231181.670.26数据可信
供试品溶液-6021301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%
5min1227016-22701654.85260.749.2554.8560.749.26
2248495-24849560.04260.04
3273237-27323766.02066.02
4267081-26708164.53264.53
5271929-27192965.70465.70
6220481-22048153.27353.27
10min1265522-26552264.15669.357.6164.2569.457.61
2286672-28667269.26669.37
3304403-30440373.55073.66
4305456-30545673.80573.91
5304277-30427773.52073.63
6255745-25574561.79361.88
15min1291741-29174170.49175.526.3270.6975.746.33
2310145-31014574.93875.15
3328462-32846279.36379.60
4328602-32860279.39779.63
5330074-33007479.75379.98
6286264-28626469.16769.36
20min1316230-31623076.40880.474.7176.7280.824.72
2332123-33212380.24880.59
3344316-34431683.19483.56
4346686-34668683.76784.13
5346905-34690583.82084.18
6312079-31207975.40575.71
30min1345883-34588383.57386.803.9084.0287.273.92
2356595-35659586.16186.63
3369231-36923189.21489.72
4374775-37477590.55491.06
5368699-36869989.08589.59
6340146-34014682.18682.62
45min1367379-36737988.76691.012.8489.3591.632.85
2370782-37078289.58990.21
3372465-37246589.99590.65
4393306-39330695.03195.68
5386688-38668893.43294.09
6369272-36927289.22489.79
60min1381394-38139492.15394.512.8192.8895.282.82
2382106-38210692.32593.09
3401273-40127396.95697.76
4403950-40395097.60398.41
5397656-39765696.08296.89
6380434-38043491.92192.64
90min1392738-39273894.89496.792.4395.7897.722.45
2390101-39010194.25795.18
3411575-41157599.445100.41
4412503-41250399.669100.64
5401958-40195897.12198.09
6394536-39453695.32896.20
120min1393448-39344895.06597.602.7096.1198.692.71
2389668-38966894.15295.23
3415675-415675100.436101.57
4415099-415099100.297101.44
5407590-40759098.48299.61
6402141-40214197.16698.20
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1404313-40431397.69199.062.2398.89100.312.24
2396059-39605995.69696.93
3418646-418646101.154102.45
4420318-420318101.558102.87
5412189-41218999.594100.89
6408280-40828098.64999.84
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%
111.963743933749923747183750893751133748610.09
2 12.003754393751563752980.06
单位质量响应值RSD%判断
31342.8931274.830.16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%
5min1266339-26633964.20962.535.1964.2162.535.19
2249380-24938060.12060.12
3276512-27651266.66166.66
4239631-23963157.77057.77
5256871-25687161.92661.93
6267572-26757264.50664.51
10min1300256-30025672.38670.383.9872.4970.493.98
2276246-27624666.59766.70
3306396-30639673.86673.98
4280445-28044567.60967.71
5292088-29208870.41670.52
6296201-29620171.40871.52
15min1324856-32485678.31677.302.8978.5477.522.89
2309316-30931674.57074.78
3332964-33296480.27180.50
4310141-31014174.76974.98
5321781-32178177.57577.80
6324836-32483678.31178.54
20min1339523-33952381.85282.082.0382.2182.432.03
2335841-33584180.96481.30
3349472-34947284.25084.62
4330026-33002679.56279.90
5343799-34379982.88383.23
6344079-34407982.95083.31
30min1365010-36501087.99687.961.2388.4988.451.24
2363623-36362387.66288.13
3371329-37132989.52090.03
4357852-35785286.27186.74
5364009-36400987.75588.24
6367357-36735788.56289.06
45min1382187-38218792.13793.301.4192.7893.931.41
2392991-39299194.74295.36
3387610-38761093.44594.10
4378765-37876591.31291.92
5390249-39024994.08194.72
6390239-39023994.07994.72
60min1392736-39273694.68195.901.5995.4896.691.58
2406884-40688498.09198.87
3401607-40160796.81997.63
4389623-38962393.93094.69
5395899-39589995.44396.23
6399974-39997496.42597.23
90min1403127-40312797.18698.451.9798.1499.401.97
2418984-418984101.008101.95
3412602-41260299.470100.44
4395814-39581495.42396.34
5411146-41114699.119100.07
6408602-40860298.50599.47
120min1405394-40539497.73299.251.6098.85100.361.59
2422774-422774101.922103.03
3411756-41175699.266100.41
4404835-40483597.59798.68
5414214-41421499.858100.97
6411120-41112099.113100.24
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1409779-40977998.78999.712.08100.07100.982.05
2429832-429832103.624104.90
3415608-415608100.194101.50
4409143-40914398.63699.88
5411190-41119099.129100.41
6405919-40591997.85999.15
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