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%
110.101578470158164615789731581494157731915795800.13
210.061577268157680215770350.03
单位质量响应值RSD%判断
156394.06156762.920.17数据可信
供试品溶液-B1009B08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%
5min11699108-169910898.82597.161.0598.8297.161.05
21678073-167807397.60197.60
31673967-167396797.36297.36
41665569-166556996.87496.87
51654122-165412296.20896.21
61652119-165211996.09296.09
10min11702697-170269799.03397.371.0399.2097.531.04
21680653-168065397.75197.91
31678776-167877697.64297.80
41667590-166759096.99197.15
51660596-166059696.58596.74
61654696-165469696.24196.40
15min11693301-169330198.48796.831.0598.8297.161.06
21672328-167232897.26797.59
31668575-166857597.04997.37
41660621-166062196.58696.91
51648561-164856195.88596.21
61645807-164580795.72496.04
20min11681151-168115197.78096.211.0598.2796.701.05
21662073-166207396.67097.16
31658882-165888296.48596.97
41651104-165110496.03296.52
51637862-163786295.26295.74
61634015-163401595.03995.52
30min11670757-167075797.17695.541.1397.8396.181.13
21652263-165226396.10096.75
31647635-164763595.83196.48
41638199-163819995.28295.93
51627947-162794794.68695.33
61618686-161868694.14794.79
极限11657357-165735796.39694.851.0597.2195.651.05
21638053-163805395.27396.08
31635801-163580195.14295.95
41627690-162769094.67195.47
51613503-161350393.84694.64
61611910-161191093.75394.55
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%
110.101576871157898315776721580963157735315783680.11
210.061574751157197315733620.13
单位质量响应值RSD%判断
156274.06156397.810.06数据可信
供试品溶液-B1009B08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%
5min11645962-164596295.88296.741.2495.8896.741.24
21664029-166402996.93496.93
31648650-164865096.03896.04
41648550-164855096.03396.03
51656302-165630296.48496.48
61700267-170026799.04599.05
10min11647879-164787995.99396.831.2296.1596.991.22
21665271-166527197.00797.17
31650318-165031896.13696.30
41651734-165173496.21896.38
51656681-165668196.50696.67
61701292-170129299.10599.27
15min11641150-164115095.60296.291.1895.9296.611.18
21653355-165335596.31296.64
31639878-163987895.52795.85
41642525-164252595.68296.00
51649706-164970696.10096.42
61690907-169090798.50098.83
20min11627683-162768394.81795.661.2995.3096.141.28
21651244-165124496.19096.67
31631252-163125295.02595.50
41627815-162781594.82595.30
51634076-163407695.18995.67
61681289-168128997.94098.43
30min11612414-161241493.92894.971.2394.5695.611.23
21634858-163485895.23595.88
31617557-161755794.22794.87
41622006-162200694.48695.12
51626688-162668894.75995.40
61667953-166795397.16397.82
极限11606658-160665893.59294.331.1794.3995.131.17
21620406-162040694.39395.20
31604994-160499493.49594.29
41611312-161131293.86394.66
51616594-161659494.17194.97
61656052-165605296.47097.29
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%
110.101574797157076515756791572522157483115737190.13
210.061580947158561615832820.21
单位质量响应值RSD%判断
155813.76157383.900.71数据可信
供试品溶液-B1009B08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%
5min11632060-163206094.91596.161.2794.9196.161.27
21624955-162495594.50294.50
31675990-167599097.47097.47
41652518-165251896.10596.10
51670279-167027997.13797.14
61664841-166484196.82196.82
10min11645788-164578895.71396.871.3095.8797.031.30
21632702-163270294.95295.11
31683687-168368797.91798.08
41670057-167005797.12597.28
51684104-168410497.94198.10
61677906-167790697.58197.74
15min11648176-164817695.85296.761.0496.1797.081.04
21637766-163776695.24795.56
31680596-168059697.73798.06
41665298-166529896.84897.17
51677483-167748397.55697.88
61673318-167331897.31497.64
20min11644482-164448295.63796.591.1396.1197.081.13
21631309-163130994.87195.35
31673495-167349597.32497.81
41665562-166556296.86397.35
51675818-167581897.46097.95
61675023-167502397.41397.90
30min11644384-164438495.63196.331.0296.2796.981.02
21629619-162961994.77395.41
31671920-167192097.23397.88
41657061-165706196.36997.01
51673034-167303497.29897.95
61662575-166257596.68997.34
极限11637720-163772095.24495.861.1896.0496.661.18
21614979-161497993.92194.71
31663915-166391596.76797.58
41648468-164846895.86996.67
51666375-166637596.91097.72
61657971-165797196.42297.23
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%
110.101575288157584515715711572717157473715740320.12
210.061580018157714115785800.13
单位质量响应值RSD%判断
155844.75156916.500.49数据可信
供试品溶液-B1009B08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%
5min11674797-167479797.53597.071.0397.5397.071.02
21648938-164893896.02996.03
31663673-166367396.88796.89
41692795-169279598.58398.58
51648102-164810295.98095.98
61672242-167224297.38697.39
10min11687964-168796498.30297.621.0298.4697.781.02
21660690-166069096.71396.87
31673770-167377097.47597.64
41704433-170443399.26199.42
51661155-166115596.74096.90
61669431-166943197.22297.38
15min11688443-168844398.32997.510.9798.6697.840.97
21654906-165490696.37696.70
31673239-167323997.44497.77
41697347-169734798.84899.18
51660242-166024296.68797.01
61671981-167198197.37197.70
20min11682985-168298598.01297.230.9298.5097.710.92
21650762-165076296.13596.62
31665597-166559796.99997.49
41690731-169073198.46398.96
51656881-165688196.49196.97
61670020-167002097.25797.74
30min11681148-168114897.90597.140.9398.5697.790.93
21649750-164975096.07696.72
31663029-166302996.84997.50
41689107-168910798.36899.03
51653848-165384896.31596.96
61671095-167109597.31997.97
极限11674481-167448197.51696.601.0698.3397.411.06
21637600-163760095.36996.17
31657259-165725996.51397.32
41684182-168418298.08198.90
51647113-164711395.92396.73
61651786-165178696.19597.01
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