磷酸奥司他韦干混悬项目信息
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101096-202103对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数100
标示量(mg)75供试品稀释倍数1系数0.7612
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.101577955157628715754991573503157498715756460.11
210.061567463156660915670360.04
单位质量响应值RSD%判断
156004.55155768.990.11数据可信
供试品溶液-B8086B03U1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%
5min11705648-170564899.64596.262.5399.6596.262.53
21654335-165433596.64796.65
31597899-159789993.35093.35
41683308-168330898.34098.34
51631925-163192595.33895.34
61612637-161263794.21194.21
10min11713569-1713569100.10896.862.54100.2797.022.54
21667492-166749297.41697.58
31610228-161022894.07194.23
41697615-169761599.17699.34
51638352-163835295.71495.87
61620072-162007294.64694.80
15min11711805-1711805100.00596.592.58100.3496.912.58
21661483-166148397.06597.39
31605976-160597693.82294.13
41691603-169160398.82499.15
51635398-163539895.54195.86
61613687-161368794.27394.59
20min11705538-170553899.63996.422.48100.1496.902.48
21656615-165661596.78097.27
31601712-160171293.57394.04
41689176-168917698.68399.18
51630861-163086195.27695.75
61618472-161847294.55295.02
30min11700115-170011599.32295.942.6699.9996.582.66
21652683-165268396.55197.20
31590296-159029692.90693.53
41681237-168123798.21998.88
51626210-162621095.00495.64
61602663-160266393.62994.26
极限11685232-168523298.45295.172.8899.2895.982.87
21632739-163273995.38696.19
31563617-156361791.34792.13
41678027-167802798.03198.85
51616957-161695794.46495.26
61598029-159802993.35894.14
磷酸奥司他韦干混悬项目信息
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101096-202103对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数100
标示量(mg)75供试品稀释倍数1系数0.7612
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.101572100157237815719071571758157122415718730.03
210.061572419157357415729960.06
单位质量响应值RSD%判断
155630.99156361.430.34数据可信
供试品溶液-B8086B03U1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%
5min11613316-161331694.18596.041.5294.1996.041.52
21655147-165514796.62796.63
31681023-168102398.13898.14
41659639-165963996.89096.89
51625439-162543994.89394.89
61635623-163562395.48895.49
10min11624580-162458094.84396.661.4195.0096.821.42
21666600-166660097.29697.46
31690194-169019498.67398.84
41666072-166607297.26597.43
51639827-163982795.73395.89
61646548-164654896.12596.28
15min11617500-161750094.43096.391.4594.7496.711.45
21664437-166443797.17097.49
31685243-168524398.38498.71
41659883-165988396.90497.23
51636259-163625995.52595.84
61643390-164339095.94196.26
20min11608090-160809093.88096.051.5494.3596.531.54
21658247-165824796.80897.29
31681381-168138198.15998.65
41655327-165532796.63897.12
51631602-163160295.25395.73
61637123-163712395.57596.05
30min11604769-160476993.68695.161.2094.3295.801.20
21653114-165311496.50997.16
31634840-163484095.44296.10
41647049-164704996.15596.80
51609614-160961493.96994.60
61630795-163079595.20695.84
极限11578241-157824192.13894.161.6992.9294.961.68
21642452-164245295.88696.69
31581900-158190092.35193.17
41637557-163755795.60096.41
51618114-161811494.46595.26
61619153-161915394.52695.32
磷酸奥司他韦干混悬项目信息
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101096-202103对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数100
标示量(mg)75供试品稀释倍数1系数0.7612
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.101576647157304115759051576675157552215755580.10
210.061565921156704415664820.06
单位质量响应值RSD%判断
155995.84155713.920.13数据可信
供试品溶液-B8086B03U1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%
5min11632922-163292295.41695.951.2995.4295.951.29
21630898-163089895.29895.30
31616311-161631194.44594.45
41668405-166840597.48997.49
51636221-163622195.60995.61
61667335-166733597.42797.43
10min11641082-164108295.89396.391.1996.0596.551.19
21641619-164161995.92496.08
31625272-162527294.96995.13
41673910-167391097.81197.97
51642616-164261695.98296.14
61672912-167291297.75397.91
15min11636415-163641595.62096.161.1495.9496.481.14
21633923-163392395.47495.79
31626537-162653795.04395.36
41672125-167212597.70798.03
51639308-163930895.78996.11
61665930-166593097.34597.67
20min11630485-163048595.27395.831.1995.7596.311.19
21629640-162964095.22495.70
31617666-161766694.52495.00
41664377-166437797.25497.74
51633814-163381495.46895.95
61663632-166363297.21097.70
30min11634162-163416295.48895.701.1296.1396.341.12
21625133-162513394.96195.60
31615177-161517794.37995.01
41659877-165987796.99197.64
51633082-163308295.42596.06
61659772-165977296.98597.63
极限11621202-162120294.73195.351.2995.5396.151.29
21623615-162361594.87295.67
31604136-160413693.73494.52
41656577-165657796.79897.61
51628107-162810795.13595.93
61656694-165669496.80597.62
磷酸奥司他韦干混悬项目信息
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101096-202103对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数100
标示量(mg)75供试品稀释倍数1系数0.7612
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.101570783156957115688821568808157100615698100.07
210.061565981156608715660340.01
单位质量响应值RSD%判断
155426.73155669.380.12数据可信
供试品溶液-B8086B03U1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%
5min11643502-164350296.22395.761.9796.2295.761.97
21615375-161537594.57794.58
31595667-159566793.42393.42
41640238-164023896.03296.03
51628679-162867995.35695.36
61690561-169056198.97998.98
10min11648457-164845796.51496.241.8596.6796.401.85
21623637-162363795.06095.22
31607378-160737894.10994.26
41650791-165079196.65096.81
51635947-163594795.78195.94
61696064-169606499.30199.47
15min11642932-164293296.19095.981.9496.5196.301.94
21621149-162114994.91595.23
31600662-160066293.71594.03
41647424-164742496.45396.77
51629392-162939295.39795.72
61694294-169429499.19799.53
20min11640813-164081396.06695.871.8996.5596.351.89
21619047-161904794.79295.27
31599703-159970393.65994.13
41649124-164912496.55397.03
51626226-162622695.21295.69
61689713-168971398.92999.42
30min11636829-163682995.83395.541.8596.4796.181.85
21615251-161525194.56995.20
31595241-159524193.39894.02
41638719-163871995.94396.59
51620585-162058594.88295.52
61684112-168411298.60199.26
极限11636373-163637395.80695.361.9296.6196.161.92
21608534-160853494.17694.97
31590779-159077993.13793.92
41636664-163666495.82396.63
51618649-161864994.76895.56
61681363-168136398.44099.27
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