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100800-202304对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3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%
111.451541395154429715435051545127154351315435670.09
211.351550982154819315495880.13
单位质量响应值RSD%判断
134809.34136527.580.90数据可信
长期24月-供试品溶液-X0734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%
240min1429879-42987929.26927.168.8829.2727.168.88
2402592-40259227.41127.41
3423652-42365228.84528.84
4332397-33239722.63122.63
5413152-41315228.13028.13
6391377-39137726.64726.65
480min1851583-85158357.98054.276.6458.0254.316.64
2779423-77942353.06753.11
3830209-83020956.52556.57
4715931-71593148.74548.78
5841085-84108557.26657.31
6763967-76396752.01552.06
720min11199232-119923281.65079.244.9781.7879.364.98
21162296-116229679.13679.26
31213024-121302482.58982.72
41062982-106298272.37472.48
51209507-120950782.35082.48
61136155-113615577.35677.47
960min11463939-146393999.673100.811.2099.93101.051.20
21488689-1488689101.358101.60
31485041-1485041101.110101.36
41477325-1477325100.584100.80
51508520-1508520102.708102.96
61460482-146048299.43899.67
1200min11458365-145836599.294100.281.2699.70100.671.26
21477728-1477728100.612101.00
31464000-146400099.677100.08
41473364-1473364100.315100.68
51506693-1506693102.584102.99
61456823-145682399.18999.57
1440min11451415-145141598.820100.271.2799.37100.811.27
21469973-1469973100.084100.63
31480036-1480036100.769101.32
41464812-146481299.733100.25
51505729-1505729102.518103.08
61464191-146419199.690100.22
极限11447597-144759798.56099.461.0099.26100.161.00
21465860-146586099.804100.50
31451603-145160398.83399.54
41460414-146041499.433100.10
51487164-1487164101.254101.97
61452446-145244698.89199.57
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100800-202304对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3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%
111.451552594155245315524201552497155176915523470.03
211.351552403155172515520640.04
单位质量响应值RSD%判断
135576.16136745.730.61数据可信
长期24月-供试品溶液-X0734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%
240min1379874-37987425.77026.926.9525.7726.926.95
2406562-40656227.58027.58
3445240-44524030.20430.20
4366915-36691524.89124.89
5398750-39875027.05027.05
6383489-38348926.01526.02
480min1758061-75806151.42554.355.5651.4654.395.56
2793079-79307953.80153.84
3874520-87452059.32659.37
4754212-75421251.16451.20
5807294-80729454.76554.81
6819737-81973755.60955.65
720min11124533-112453376.28680.073.2276.4080.203.22
21178538-117853879.94980.07
31231966-123196683.57483.71
41152750-115275078.20078.31
51191332-119133280.81780.94
61203144-120314481.61981.74
960min11462351-146235199.203100.361.2899.43100.601.28
21460676-146067699.08999.33
31474375-1474375100.018100.28
41494340-1494340101.373101.60
51475370-1475370100.086100.33
61508929-1508929102.362102.61
1200min11454522-145452298.672100.261.5599.05100.651.54
21460323-146032399.06599.46
31468166-146816699.597100.01
41490791-1490791101.132101.52
51477210-1477210100.211100.60
61516478-1516478102.875103.27
1440min11450073-145007398.37099.831.4598.90100.371.45
21451102-145110298.44098.98
31459810-145981099.03099.59
41483392-1483392100.630101.17
51481802-1481802100.522101.07
61503271-1503271101.979102.53
极限11448571-144857198.26899.401.1198.94100.091.11
21450409-145040998.39399.08
31462665-146266599.22499.93
41479358-1479358100.356101.04
51460647-146064799.08799.78
61489621-1489621101.053101.76
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