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%
19.911532123153363415375781539098154004515364960.23
29.931564281156688415655820.12
单位质量响应值RSD%判断
155045.01157661.831.19数据可信
供试品溶液-2024111821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%
5min11477916-147791686.00386.444.4786.0086.444.47
21422169-142216982.75982.76
31569098-156909891.30991.31
41532439-153243989.17689.18
51396502-139650281.26581.27
61513946-151394688.09988.10
10min11526475-152647588.82888.872.5189.7889.822.53
21497523-149752387.14488.06
31565788-156578891.11692.13
41569276-156927691.31992.31
51471125-147112585.60886.51
61532501-153250189.17990.16
15min11577905-157790591.82190.162.2193.7692.102.23
21512823-151282388.03489.92
31571014-157101491.42093.45
41581526-158152692.03294.04
51502437-150243787.43089.28
61550162-155016290.20792.18
20min11575499-157549991.68190.341.6794.6493.291.71
21519526-151952688.42491.29
31566395-156639591.15194.19
41575541-157554191.68494.71
51520988-152098888.50991.33
61557250-155725090.61993.59
30min11531429-153142989.11790.410.9593.1094.370.95
21543600-154360089.82593.67
31566393-156639391.15195.21
41556153-155615390.55594.60
51553109-155310990.37894.19
61571554-157155491.45295.43
极限11545287-154528789.92390.711.5394.8995.671.39
21548374-154837490.10394.95
31545321-154532189.92594.99
41537509-153750989.47194.52
51597665-159766592.97197.78
61578963-157896391.88396.88
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%
19.911537214153721015344581536123153676815363550.08
29.931535705153595715358310.02
单位质量响应值RSD%判断
155030.78154665.760.17数据可信
供试品溶液-2024111821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%
5min11693140-169314099.478101.512.6899.48101.512.68
21718017-1718017100.939100.94
31696995-169699599.70499.70
41710856-1710856100.519100.52
51729292-1729292101.602101.60
61817949-1817949106.811106.81
10min11679128-167912898.655100.011.1299.76101.141.12
21709202-1709202100.422101.54
31682992-168299298.88299.99
41706918-1706918100.287101.40
51730812-1730812101.691102.82
61704215-1704215100.129101.32
15min11658951-165895197.46999.521.3299.67101.761.29
21690991-169099199.352101.59
31725291-1725291101.367103.57
41702599-1702599100.034102.26
51702583-1702583100.033102.29
61683185-168318598.893101.19
20min11639575-163957596.33197.620.9999.62100.970.99
21668948-166894898.057101.40
31645009-164500996.65099.98
41668547-166854798.033101.38
51683670-168367098.921102.29
61663338-166333897.727101.13
30min11621259-162125995.25596.500.9699.61100.920.95
21651369-165136997.024101.45
31628611-162861195.687100.09
41648262-164826296.841101.27
51664202-166420297.778102.25
61640759-164075996.400100.88
极限11600674-160067494.04595.260.9699.46100.760.96
21628870-162887095.702101.21
31605304-160530494.31799.79
41628514-162851495.681101.19
51641631-164163196.452102.01
61622861-162286195.349100.90
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