氟伐他汀钠片项目信息
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%
110.741412344141859114191621419074141904214176430.21
211.231479153147730014782260.09
单位质量响应值RSD%判断
131996.55131631.880.20数据可信
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%
240min1275841-27584118.55421.8418.0818.5521.8418.08
2281878-28187818.96118.96
3311904-31190420.98020.98
4351028-35102823.61223.61
5296258-29625819.92819.93
6431116-43111628.99929.00
480min1584970-58497039.34846.4016.0639.3846.4416.06
2593108-59310839.89539.92
3683694-68369445.98946.02
4754774-75477450.77050.81
5646090-64609043.45943.49
6876335-87633558.94758.99
720min1924008-92400862.15367.928.1262.2468.038.13
2940739-94073963.27963.37
3973087-97308765.45565.56
41119746-111974675.32075.43
51002032-100203267.40267.50
61099165-109916573.93574.07
960min11164520-116452078.33185.757.1678.5185.957.17
21197605-119760580.55780.74
31269838-126983885.41685.61
41403380-140338094.39894.62
51257298-125729884.57284.77
61356135-135613591.22091.46
1200min11412794-141279495.03296.492.2295.3396.832.24
21445942-144594297.26197.57
31402588-140258894.34594.67
41473211-147321199.09599.46
51405325-140532594.52994.85
61467429-146742998.70799.09
1440min11469664-146966498.85799.191.3999.3099.671.38
21510973-1510973101.636102.09
31461503-146150398.30898.78
41465766-146576698.59599.11
51455211-145521197.88598.35
61484641-148464199.864100.39
极限11471316-147131698.96899.291.3899.5699.911.36
21513652-1513652101.816102.42
31463935-146393598.47299.09
41464614-146461498.51799.18
51459326-145932698.16298.77
61483450-148345099.784100.46
氟伐他汀钠片项目信息
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%
110.741417629141755814148871416529141468014162570.10
211.231485825149075614882900.24
单位质量响应值RSD%判断
131867.50132528.050.36数据可信
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%
240min1377998-37799825.35225.2515.7725.3525.2515.76
2336533-33653322.57122.57
3325758-32575821.84921.85
4473083-47308331.73031.73
5417678-41767828.01428.01
6327521-32752121.96721.97
480min1747117-74711750.10951.4111.2650.1551.4511.26
2702583-70258347.12247.16
3708768-70876847.53747.57
4909849-90984961.02461.07
5831979-83197955.80155.84
6698634-69863446.85746.89
720min11094680-109468073.42070.704.9673.5370.824.96
21081792-108179272.55672.66
3998918-99891866.99867.10
41111396-111139674.54174.68
51053759-105375970.67670.80
6984265-98426566.01566.12
960min11394915-139491593.55788.844.9293.7889.064.92
21357252-135725291.03191.24
31252985-125298584.03884.24
41381780-138178092.67692.93
51318190-131819088.41188.64
61242556-124255683.33883.54
1200min11477812-147781299.11797.072.4699.4897.422.46
21488202-148820299.814100.16
31412629-141262994.74595.08
41471891-147189198.72099.11
51418437-141843795.13595.50
61414586-141458694.87695.20
1440min11472051-147205198.73198.700.7899.2499.190.78
21489109-148910999.875100.37
31466310-146631098.34698.82
41478185-147818599.14299.68
51455731-145573197.63698.14
61467765-146776598.44398.91
极限11471555-147155598.69798.680.5899.3699.330.58
21483306-148330699.485100.13
31469149-146914998.53699.16
41474745-147474598.91199.60
51457177-145717797.73398.39
61472200-147220098.74199.36
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