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%
19.861507405150620315076601505225150659115066170.07
29.931508312150933815088250.05
单位质量响应值RSD%判断
152800.91151946.120.40数据可信
供试品溶液-2024111821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%
5min11677090-1677090100.13699.613.29100.1499.623.29
21585044-158504494.64094.64
31652402-165240298.66298.66
41695852-1695852101.256101.26
51749656-1749656104.469104.47
61650040-165004098.52198.52
10min11662167-166216799.24599.412.79100.36100.522.79
21608856-160885696.06297.11
31637734-163773497.78698.88
41690543-1690543100.939102.06
51741910-1741910104.006105.17
61648686-164868698.44099.53
15min11643243-164324398.11598.382.78100.33100.592.79
21594392-159439295.19897.32
31622476-162247696.87599.06
41669788-166978899.700101.95
51726198-1726198103.068105.38
61629627-162962797.30299.49
20min11621685-162168596.82897.212.70100.13100.512.71
21577805-157780594.20897.38
31602426-160242695.67898.94
41649444-164944498.485101.84
51703859-1703859101.734105.20
61613213-161321396.32299.59
30min11605592-160559295.86796.092.83100.25100.482.83
21557291-155729192.98397.21
31582523-158252394.48998.81
41628965-162896597.262101.71
51688430-1688430100.813105.40
61593293-159329395.13399.47
极限11586649-158664994.73695.072.77100.18100.522.78
21541545-154154592.04397.30
31567967-156796793.62098.99
41614522-161452296.400101.93
51667895-166789599.587105.30
61574870-157487094.03399.43
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%
19.861493301149513714940871495069149524514945680.06
29.931503894150348015036870.02
单位质量响应值RSD%判断
151578.90151428.700.08数据可信
供试品溶液-2024111921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%
5min11632425-163242598.02895.802.8398.0395.802.84
21624393-162439397.54597.55
31593549-159354995.69395.69
41632055-163205598.00698.01
51572483-157248394.42894.43
61517278-151727891.11391.11
10min11654824-165482499.37398.051.14100.4699.121.16
21637805-163780598.35199.43
31622267-162226797.41898.48
41646347-164634798.86499.95
51633536-163353698.09499.14
61602429-160242996.22797.24
15min11639925-163992598.47897.271.01100.6799.431.02
21625607-162560797.61899.79
31611207-161120796.75498.90
41628853-162885397.813100.00
51620575-162057597.31699.46
61592976-159297695.65997.74
20min11622502-162250297.43296.400.97100.7299.640.99
21611919-161191996.796100.06
31595799-159579995.82899.05
41615504-161550497.012100.29
51607247-160724796.51699.74
61579410-157941094.84497.99
30min11605751-160575196.42695.371.00100.8099.681.02
21591544-159154495.57399.91
31582507-158250795.03099.32
41596241-159624195.855100.21
51592956-159295695.65899.95
61559774-155977493.66597.86
极限11584384-158438495.14394.250.89100.5899.620.91
21573531-157353194.49199.89
31562104-156210493.80599.15
41577568-157756894.734100.15
51574271-157427194.53699.89
61545522-154552292.80998.05
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%
19.861507929150368515054221507324150478115058280.12
29.931500109149977514999420.02
单位质量响应值RSD%判断
152720.89151051.560.78数据可信
供试品溶液-2024111921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%
5min11559123-155912393.39395.733.5893.3995.733.58
21583113-158311394.83094.83
31574695-157469594.32694.33
41653570-165357099.05099.05
51682397-1682397100.777100.78
61536038-153603892.01092.01
10min11624374-162437497.30297.942.6298.3499.012.63
21606631-160663196.23997.29
31594256-159425695.49896.55
41672587-1672587100.190101.29
51702515-1702515101.982103.10
61610245-161024596.45597.48
15min11636534-163653498.03097.492.25100.1599.642.25
21597242-159724295.67697.80
31590419-159041995.26897.38
41657861-165786199.308101.52
51680105-1680105100.640102.89
61603214-160321496.03498.13
20min11635569-163556997.97296.752.35101.1899.982.36
21581412-158141294.72897.91
31575214-157521494.35797.52
41641688-164168898.339101.66
51667053-166705399.858103.23
61589883-158988395.23698.40
30min11634813-163481397.92795.902.51102.22100.212.50
21562967-156296793.62397.86
31555798-155579893.19497.41
41624564-162456497.313101.72
51649519-164951998.808103.29
61578552-157855294.55798.78
极限11632208-163220897.77195.012.41103.16100.392.38
21555750-155575093.19198.47
31537431-153743192.09497.35
41606924-160692496.256101.75
51618022-161802296.921102.50
61566622-156662293.84299.11
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