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101096-202103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%
110.161563300156517215697431571247157171615682360.25
210.091568407157141515699110.14
单位质量响应值RSD%判断
154353.94155590.780.57数据可信
供试品溶液-2024102721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%
5min11761776-1761776103.533100.602.17103.53100.602.17
21715802-1715802100.831100.83
31733904-1733904101.895101.90
41656761-165676197.36297.36
51683698-168369898.94598.94
61719151-1719151101.028101.03
10min11746774-1746774102.651100.531.40103.80101.651.41
21705873-1705873100.248101.37
31720609-1720609101.114102.25
41682683-168268398.88599.97
51687504-168750499.168100.27
61720996-1720996101.136102.26
15min11729142-1729142101.61599.511.37103.91101.751.38
21688064-168806499.201101.44
31701206-170120699.973102.23
41663336-166333697.74899.93
51675390-167539098.456100.66
61703196-1703196100.090102.34
20min11709479-1709479100.46098.271.45103.88101.611.46
21667942-166794298.019101.36
31681323-168132398.805102.17
41645056-164505696.67499.94
51647461-164746196.815100.11
61681696-168169698.827102.19
30min11688101-168810199.20397.031.41103.74101.461.42
21647063-164706396.792101.22
31659298-165929897.511101.97
41625191-162519195.50699.85
51628527-162852795.702100.07
61658566-165856697.468101.92
极限11667044-166704497.96695.841.53103.60101.351.53
21618027-161802795.085100.59
31642283-164228396.511102.06
41604625-160462594.29899.70
51606861-160686194.42999.86
61646213-164621396.742102.28
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101096-202103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%
110.161569443157060715695931569528157066715699680.04
210.091567504157049515690000.14
单位质量响应值RSD%判断
154524.41155500.500.45数据可信
供试品溶液-2024102721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%
5min11777988-1777988104.45898.763.71104.4698.763.71
21624889-162488995.46395.46
31643719-164371996.57096.57
41647175-164717596.77396.77
51652208-165220897.06897.07
61740155-1740155102.235102.24
10min11769730-1769730103.97399.553.16105.13100.643.16
21689036-168903699.232100.29
31641538-164153896.44197.51
41660157-166015797.53598.61
51655815-165581597.28098.36
61750090-1750090102.819103.95
15min11746097-1746097102.58498.383.18104.90100.583.18
21675367-167536798.429100.59
31625043-162504395.47297.62
41632069-163206995.88598.04
51636811-163681196.16498.32
61731933-1731933101.752104.03
20min11729011-1729011101.58197.313.30105.04100.613.30
21663216-166321697.715100.97
31605588-160558894.32997.53
41606872-160687294.40597.63
51620135-162013595.18498.41
61713274-1713274100.656104.06
30min11704491-1704491100.14095.903.34104.72100.283.33
21638440-163844096.259100.60
31579159-157915992.77797.03
41581803-158180392.93297.21
51600808-160080894.04998.33
61689057-168905799.233103.76
极限11600536-160053694.03393.942.4499.7399.392.44
21614239-161423994.838100.25
31566556-156655692.03697.32
41564108-156410891.89297.20
51580555-158055592.85998.19
61668026-166802697.998103.63
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101096-202103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%
110.161571371157239615714951573037157158315719760.05
210.091568878157169115702840.13
单位质量响应值RSD%判断
154722.05155627.750.42数据可信
供试品溶液-2024102721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%
5min11655554-165555497.16395.956.7997.1695.956.79
21413583-141358382.96282.96
31646998-164699896.66196.66
41701073-170107399.83499.83
51702458-170245899.91699.92
61689587-168958799.16099.16
10min11673734-167373498.23098.512.5899.3199.572.63
21597430-159743093.75294.67
31673821-167382198.23599.31
41706844-1706844100.173101.28
51710931-1710931100.413101.52
61708110-1708110100.247101.35
15min11660180-166018097.43497.861.7799.61100.021.83
21616391-161639194.86596.83
31657921-165792197.30299.47
41693501-169350199.390101.61
51692696-169269699.343101.57
61684012-168401298.833101.05
20min11639886-163988696.24396.811.7299.50100.061.78
21602524-160252494.05197.07
31638061-163806196.13699.38
41673760-167376098.231101.56
51673344-167334498.207101.54
61670023-167002398.012101.33
30min11623059-162305995.25695.761.5799.58100.091.63
21589867-158986793.30897.37
31620066-162006695.08099.40
41653599-165359997.048101.47
51653007-165300797.013101.43
61650753-165075396.881101.28
极限11606043-160604394.25794.741.4499.64100.121.51
21577341-157734192.57397.67
31602121-160212194.02799.40
41635612-163561295.993101.49
51633358-163335895.860101.36
61630668-163066895.702101.18
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101096-202103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%
110.161572014157265815716061572903157299815724360.04
210.091564592156789815662450.15
单位质量响应值RSD%判断
154767.32155227.450.21数据可信
供试品溶液-2024102721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%
5min11586328-158632893.20694.402.4993.2194.402.49
21542214-154221490.61490.61
31642267-164226796.49396.49
41642996-164299696.53696.54
51632245-163224595.90495.90
61594184-159418493.66893.67
10min11628218-162821895.66796.361.2496.7097.421.25
21611258-161125894.67195.68
31661017-166101797.59598.67
41653015-165301597.12498.20
51658209-165820997.43098.50
61628681-162868195.69596.74
15min11613041-161304194.77695.631.3996.8797.751.39
21602854-160285494.17796.24
31641430-164143096.44498.60
41633533-163353395.98098.13
51662634-166263497.69099.84
61611964-161196494.71296.82
20min11595795-159579593.76294.460.7996.9197.640.81
21600556-160055694.04297.15
31621215-162121595.25698.48
41615676-161567694.93198.15
51619465-161946595.15398.39
61592961-159296193.59696.75
30min11582426-158242692.97793.310.7697.1797.540.78
21575904-157590492.59496.74
31599447-159944793.97798.26
41595245-159524593.73098.00
51601202-160120294.08098.37
61574602-157460292.51796.71
极限11569454-156945492.21592.320.7597.4497.590.78
21556430-155643091.45096.63
31584577-158457793.10398.43
41575858-157585892.59197.91
51582132-158213292.96098.30
61559088-155908891.60696.83
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