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%
111.011445493144365714443741443682144447914443370.06
210.721435038143734314361900.12
单位质量响应值RSD%判断
131184.11133972.951.49数据可信
供试品溶液-24051401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%
240min1234427-23442715.68016.704.9415.6816.704.94
2268064-26806417.92917.93
3237921-23792115.91315.91
4249422-24942216.68216.68
5256360-25636017.14617.15
6251984-25198416.85416.85
480min1430652-43065228.80431.195.1428.8331.225.14
2489239-48923932.72232.75
3454841-45484130.42230.45
4458120-45812030.64130.67
5495624-49562433.15033.18
6469328-46932831.39131.42
720min1605887-60588740.52444.085.5640.5944.155.56
2668295-66829544.69944.77
3657509-65750943.97744.05
4638299-63829942.69242.76
5716324-71632447.91147.99
6668060-66806044.68344.76
960min1773380-77338051.72757.067.1751.8557.207.16
2835801-83580155.90256.05
3867366-86736658.01358.15
4821447-82144754.94255.08
5956510-95651063.97664.12
6864197-86419757.80157.94
1200min1956825-95682563.99774.7112.3964.2074.9412.37
21040998-104099869.62769.85
31162058-116205877.72477.95
41060640-106064070.94071.16
51360107-136010790.97091.21
61121714-112171475.02575.25
1440min11225158-122515881.94490.697.6782.2591.037.66
21275591-127559185.31785.65
31428443-142844395.54195.88
41325200-132520088.63588.96
51510858-1510858101.053101.43
61370606-137060691.67292.01
极限11337834-133783489.48095.034.1289.9095.504.13
21397221-139722193.45293.91
31453599-145359997.22397.71
41402477-140247793.80494.26
51511430-1511430101.091101.62
61422019-142201995.11195.59
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%
111.011439856143991914384751440447143835514394100.07
210.721429930143077314303520.05
单位质量响应值RSD%判断
130736.60133428.361.45数据可信
供试品溶液-24051402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%
240min1266809-26680917.91218.296.2217.9118.296.22
2272871-27287118.31918.32
3279224-27922418.74618.75
4257215-25721517.26817.27
5256440-25644017.21617.22
6301928-30192820.27020.27
480min1493530-49353033.13334.255.0933.1634.285.09
2506525-50652534.00634.03
3509855-50985534.22934.26
4496972-49697233.36433.39
5492779-49277933.08333.11
6561120-56112037.67137.70
720min1687739-68773946.17148.155.3446.2548.235.34
2703055-70305547.20047.28
3700245-70024547.01147.09
4719522-71952248.30548.38
5700489-70048947.02747.10
6792568-79256853.20953.30
960min1883489-88348959.31363.538.1559.4663.688.14
2895764-89576460.13760.29
3894593-89459360.05960.21
4996458-99645866.89767.05
5928031-92803162.30462.45
61079388-107938872.46572.63
1200min11162954-116295478.07585.5310.0978.3185.7810.08
21175432-117543278.91379.15
31194985-119498580.22680.47
41403435-140343594.22094.47
51242341-124234183.40583.64
61465243-146524398.36998.64
1440min11456659-145665997.79399.074.0298.1499.444.03
21413211-141321194.87695.23
31410426-141042694.68995.05
41524486-1524486102.347102.74
51493797-1493797100.286100.65
61555184-1555184104.408104.83
极限11515008-1515008101.710102.012.18102.21102.542.20
21474265-147426598.97599.48
31496233-1496233100.450100.95
41531862-1531862102.842103.39
51528737-1528737102.632103.15
61570876-1570876105.461106.04
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