氟伐他汀钠缓释片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号100800-202103对照品来源中检院对照品使用方法直接使用
对照品含量(%)93.4对照品水分(%)0对照品稀释倍数125
标示量(mg)80供试品稀释倍数1系数0.9493
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.991414755141547614161401415828141569314155780.04
211.141410460140696414087120.18
单位质量响应值RSD%判断
128806.01126455.301.31数据可信
影响因素30天-供试品溶液-2024041821批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
240min1283352-28335219.68619.576.9719.6919.576.97
2290078-29007820.15320.15
3297887-29788720.69620.70
4242948-24294816.87916.88
5290184-29018420.16120.16
6285700-28570019.84919.85
480min1509316-50931635.38535.188.6135.4135.208.61
2532687-53268737.00937.04
3528969-52896936.75036.78
4419071-41907129.11529.14
5528147-52814736.69336.72
6519751-51975136.11036.14
720min1709768-70976849.31249.288.3449.3949.368.34
2753083-75308352.32152.41
3738805-73880551.32951.42
4592082-59208241.13541.20
5732091-73209150.86250.95
6729750-72975050.70050.78
960min1887502-88750261.66061.948.7161.8262.108.71
2971528-97152867.49767.66
3936015-93601565.03065.19
4745322-74532251.78251.91
5907334-90733463.03863.20
6901527-90152762.63462.79
1200min11175679-117567981.68182.8911.2081.9383.1411.19
21360559-136055994.52694.79
31273648-127364888.48788.75
4960277-96027766.71666.92
51203361-120336183.60483.86
61185252-118525282.34682.60
1440min11434925-143492599.69298.394.21100.0698.774.23
21458075-1458075101.301101.71
31456076-1456076101.162101.56
41300272-130027290.33790.65
51439942-1439942100.041100.42
61408089-140808997.82898.21
极限11455189-1455189101.100100.601.64101.62101.121.67
21460963-1460963101.501102.06
31461203-1461203101.518102.06
41401222-140122297.35197.79
51462912-1462912101.637102.17
61446031-1446031100.464100.99
氟伐他汀钠缓释片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号100800-202103对照品来源中检院对照品使用方法直接使用
对照品含量(%)93.4对照品水分(%)0对照品稀释倍数125
标示量(mg)80供试品稀释倍数1系数0.9493
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.991415820141651014176251417089141738414168860.06
211.141433585143215614328700.08
单位质量响应值RSD%判断
128925.02128623.880.17数据可信
影响因素30天-供试品溶液-2024041821批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
240min1297818-29781820.50620.533.3120.5120.533.31
2312231-31223121.49821.50
3304941-30494120.99621.00
4298652-29865220.56320.56
5284488-28448819.58819.59
6290815-29081520.02320.02
480min1537117-53711736.98236.831.6837.0136.861.68
2547660-54766037.70837.74
3537797-53779737.02937.06
4526178-52617836.22936.26
5537669-53766937.02037.05
6522960-52296036.00736.04
720min1740878-74087851.01151.531.6651.1051.621.66
2760724-76072452.37852.47
3752867-75286751.83751.92
4737493-73749350.77850.86
5763902-76390252.59752.68
6734859-73485950.59750.68
960min1906257-90625762.39865.603.2462.5665.763.23
2974129-97412967.07167.24
3979428-97942867.43667.60
4964368-96436866.39966.56
5970361-97036166.81266.98
6921742-92174263.46463.62
1200min11204274-120427482.91892.235.7083.1792.495.69
21371394-137139494.42494.69
31382949-138294995.22095.49
41402736-140273696.58296.84
51382234-138223495.17195.43
61293335-129333589.05089.30
1440min11434739-143473998.786100.821.0599.17101.221.05
21468998-1468998101.145101.55
31472715-1472715101.400101.81
41476844-1476844101.685102.09
51461933-1461933100.658101.06
61470233-1470233101.230101.62
极限11461071-1461071100.599100.990.54101.13101.540.55
21477338-1477338101.719102.28
31473257-1473257101.438102.00
41470175-1470175101.226101.78
51458479-1458479100.420100.98
61460078-1460078100.530101.07
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