磷酸奥司他韦干混悬剂项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号101096-202404对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6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%
19.861522650152275715235021525759152485615239050.09
29.931523417152435315238850.05
单位质量响应值RSD%判断
154554.26153462.740.51数据可信
供试品溶液-2024112021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%
5min11662799-166279998.22998.571.7298.2398.571.72
21643229-164322997.07397.07
31715957-1715957101.369101.37
41637564-163756496.73896.74
51669215-166921598.60898.61
61682292-168229299.38199.38
10min11670448-167044898.68199.001.7099.77100.091.70
21649179-164917997.42498.50
31725426-1725426101.929103.06
41649501-164950197.44398.52
51672931-167293198.82899.92
61687362-168736299.680100.78
15min11655622-165562297.80598.121.6199.99100.321.61
21629145-162914596.24198.40
31704899-1704899100.716102.97
41640932-164093296.93799.09
51660864-166086498.115100.31
61674587-167458798.925101.14
20min11641748-164174896.98596.901.66100.26100.191.66
21612967-161296795.28598.52
31685596-168559699.576102.95
41612780-161278095.27498.51
51637040-163704096.70799.99
61651749-165174997.576100.89
30min11621606-162160695.79695.921.70100.15100.281.70
21594188-159418894.17698.47
31667223-166722398.490102.97
41597490-159749094.37198.66
51619892-161989295.694100.05
61641747-164174796.985101.38
极限11601213-160121394.59194.741.50100.01100.171.51
21575435-157543593.06898.40
31646448-164644897.263102.84
41589384-158938493.89299.23
51600693-160069394.56099.98
61609766-160976695.096100.57
磷酸奥司他韦干混悬剂项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号101096-202404对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6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%
19.861522167152153215211751524735152453815228290.12
29.931521217152187715215470.04
单位质量响应值RSD%判断
154445.13153227.290.56数据可信
供试品溶液-2024112021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%
5min11724309-1724309101.97797.673.84101.9897.683.84
21653089-165308997.76597.77
31661730-166173098.27698.28
41707705-1707705100.995101.00
51610200-161020095.22995.23
61552313-155231391.80591.81
10min11730266-1730266102.32997.733.74103.4698.823.74
21648744-164874497.50898.59
31664161-166416198.42099.51
41700793-1700793100.586101.71
51613247-161324795.40996.47
61557850-155785092.13393.15
15min11714462-1714462101.39596.663.86103.6698.833.85
21633739-163373996.62198.79
31639797-163979796.97999.16
41685343-168534399.673101.91
51594915-159491594.32596.44
61538431-153843190.98493.03
20min11697940-1697940100.41895.563.90103.8198.813.89
21612229-161222995.34998.59
31619829-161982995.79899.06
41667059-166705998.591101.94
51575751-157575193.19196.36
61522226-152222690.02693.08
30min11677057-167705799.18394.463.87103.7098.773.87
21592860-159286094.20398.51
31604075-160407594.86699.19
41647567-164756797.439101.88
51556984-155698492.08196.28
61505144-150514489.01693.07
极限11659423-165942398.14094.043.08103.7599.403.11
21580382-158038293.46598.81
31588047-158804793.91899.30
41633901-163390196.630102.16
51539049-153904991.02196.25
61539839-153983991.06796.11
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