磷酸奥司他韦干糖项目信息
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%
110.511576721157743115657541580370157153415743620.37
210.441569345156816815687560.06
单位质量响应值RSD%判断
149796.57150263.980.23数据可信
供试品溶液-24100901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%
5min11431112-143111286.87089.783.3386.8789.783.33
21541177-154117793.55193.55
31522505-152250592.41892.42
41427039-142703986.62386.62
51501659-150165991.15391.15
61450701-145070188.05988.06
10min11547937-154793793.96295.291.0394.9396.291.05
21590826-159082696.56597.60
31581100-158110095.97597.00
41556734-155673494.49695.46
51577546-157754695.75996.77
61565050-156505095.00095.98
15min11539440-153944093.44694.841.0595.4696.901.07
21581074-158107495.97398.09
31578638-157863895.82597.92
41560392-156039294.71896.73
51565782-156578295.04597.12
61549329-154932994.04696.08
20min11524390-152439092.53293.920.9995.5897.031.01
21562935-156293594.87298.05
31560671-156067194.73597.89
41550914-155091494.14297.21
51551301-155130194.16697.30
61533533-153353393.08796.17
30min11564032-156403294.93993.970.9699.0198.120.88
21549789-154978994.07498.31
31536147-153614793.24697.46
41535514-153551493.20897.32
51535558-153555893.21097.39
61567367-156736795.14199.25
极限11495741-149574190.79392.001.0295.9297.201.02
21537526-153752693.33098.61
31523340-152334092.46997.72
41519645-151964592.24497.39
51517627-151762792.12297.34
61500192-150019291.06396.23
磷酸奥司他韦干糖项目信息
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%
110.511565587157111215694681567533157099315689390.16
210.441565249156620215657260.05
单位质量响应值RSD%判断
149280.59149973.750.33数据可信
供试品溶液-24101501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%
5min11527333-152733392.96194.753.1692.9694.753.16
21543330-154333093.93593.93
31563923-156392395.18895.19
41627008-162700899.02899.03
51487480-148748090.53590.54
61591469-159146996.86596.86
10min11649895-1649895100.421100.141.47101.45101.191.48
21623530-162353098.81699.86
31656547-1656547100.826101.88
41670016-1670016101.645102.75
51608495-160849597.90198.91
61662773-1662773101.205102.28
15min11657979-1657979100.91399.771.37103.06101.941.38
21612135-161213598.122100.26
31646914-1646914100.239102.42
41657417-1657417100.879103.11
51609462-160946297.960100.05
61651382-1651382100.511102.71
20min11645154-1645154100.13298.901.28103.40102.181.29
21599488-159948897.353100.58
31630704-163070499.253102.54
41643837-1643837100.052103.40
51599198-159919897.335100.52
61631464-163146499.299102.62
30min11629529-162952999.18198.481.74103.56102.851.71
21584030-158403096.412100.73
31610679-161067998.034102.43
41627614-162761499.065103.53
51594273-159427397.035101.30
61661932-1661932101.153105.57
极限11639227-163922799.77197.651.60105.26103.121.57
21566166-156616695.325100.71
31618821-161882198.529104.01
41611863-161186398.106103.67
51586535-158653596.564101.91
61603332-160333297.587103.13
磷酸奥司他韦干糖项目信息
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%
110.511568246156773915698141566552156443715673580.13
210.441566252156730415667780.05
单位质量响应值RSD%判断
149130.16150074.520.45数据可信
供试品溶液-24101502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%
5min11464827-146482789.17287.773.2189.1787.773.21
21427256-142725686.88586.88
31523397-152339792.73792.74
41412032-141203285.95885.96
51428457-142845786.95886.96
61394682-139468284.90284.90
10min11534990-153499093.44392.801.4394.4393.771.45
21519436-151943692.49693.46
31563565-156356595.18296.21
41505863-150586391.67092.62
51509286-150928691.87892.84
61512978-151297892.10393.05
15min11534094-153409493.38892.681.0695.4294.691.09
21518592-151859292.44594.44
31549441-154944194.32396.41
41506757-150675791.72493.70
51512585-151258592.07994.07
61513576-151357692.13994.11
20min11517803-151780392.39792.230.8795.4695.260.89
21508524-150852491.83294.85
31533364-153336493.34496.48
41498089-149808991.19794.19
51506338-150633891.69994.71
61525860-152586092.88795.88
30min11504657-150465791.59691.100.8095.6995.160.83
21491515-149151590.79694.84
31514879-151487992.21996.39
41482219-148221990.23194.24
51497210-149721091.14395.17
61488154-148815490.59294.61
极限11486591-148659190.49790.260.8895.6195.340.90
21477296-147729689.93194.98
31505319-150531991.63796.83
41468941-146894189.42294.43
51485542-148554290.43395.47
61473002-147300289.66994.70
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