磷酸奥司他韦干糖浆项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)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500
标示量(mg)75供试品稀释倍数5系数0.7612
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.173139403139253136163138573133293137330.09
210.163136243140973138600.11
单位质量响应值RSD%判断
30848.8730891.730.10数据可信
加速3月-供试品溶液-2024051721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%
5min1304870-30487089.93994.362.6989.9494.372.69
2328885-32888597.02497.02
3326077-32607796.19596.20
4317001-31700193.51893.52
5318729-31872994.02894.03
6323673-32367395.48695.49
10min1324083-32408395.60796.991.2996.1197.521.29
2327333-32733396.56697.11
3331220-33122097.71398.25
4330479-33047997.49498.01
5324554-32455495.74696.27
6334961-33496198.81699.35
15min1321868-32186894.95496.751.8795.9897.811.87
2329037-32903797.06998.14
3326144-32614496.21597.29
4327898-32789896.73397.79
5323569-32356995.45696.51
6339237-339237100.078101.16
20min1322656-32265695.18695.810.9896.7497.400.98
2330226-33022697.41999.03
3325932-32593296.15397.76
4322511-32251195.14396.74
5321769-32176994.92596.51
6325435-32543596.00697.64
极限1329385-32938597.17196.131.2699.2698.271.24
2329035-32903597.06899.22
3322302-32230295.08297.23
4324290-32429095.66897.80
5320394-32039494.51996.63
6329815-32981597.29899.47
磷酸奥司他韦干糖浆项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)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500
标示量(mg)75供试品稀释倍数5系数0.7612
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.173130773135263134043128853131143132010.09
210.163130253130303130280.01
单位质量响应值RSD%判断
30796.5630809.840.04数据可信
长期3月-供试品溶液-2024051721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%
5min1311396-31139692.06590.591.5892.0690.591.57
2307180-30718090.81890.82
3309808-30980891.59591.60
4301392-30139289.10789.11
5299568-29956888.56888.57
6309039-30903991.36891.37
10min1322997-32299795.49495.721.4096.0196.231.39
2324795-32479596.02696.53
3321214-32121494.96795.48
4331683-33168398.06298.56
5318236-31823694.08794.58
6323734-32373495.71296.22
15min1321308-32130894.99595.971.4096.0497.011.39
2332989-33298998.44999.49
3324062-32406295.80996.85
4323059-32305995.51396.55
5320412-32041294.73095.74
6325886-32588696.34997.39
20min1324446-32444695.92395.591.5497.4997.161.53
2331889-33188998.12399.71
3323646-32364695.68697.25
4318790-31879094.25195.82
5317972-31797294.00995.55
6323243-32324395.56797.14
极限1321935-32193595.18093.131.1797.2895.231.14
2312586-31258692.41694.55
3314637-31463793.02395.12
4311492-31149292.09394.19
5314265-31426592.91394.98
6315136-31513693.17095.28
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