Chinese Journal of Pharmacovigilance ›› 2013, Vol. 10 ›› Issue (5): 272-275.
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LIU Min-hong ,DONG Jin LU Juan
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Abstract: Objective To evaluate the quality status of fenofibrate preparation and exsisting problems. Methods According to the general requirements of Jiangsu province assessment programs in 2011, use statutory testing Methods and combine with the exploratory research to examine samples, evaluate the quality status of fenofibrate preparation by statistical analysis of the Results . Results In 98 batches of samples, all products quality can meet the current standards (100% ) in terms of weight variation, disintegration time, dissolution, related substances and determination of content. Conclusion At present the preparation quality is generally good. But exploratory research shows that current standards are defective, the dissolution assay time is suggested to be added.
Key words: fenofibrate, evaluative testing, quality evaluation
CLC Number:
R917
LIU Min-hong ,DONG Jin LU Juan. Sampling Results and Quality Assessment of Fenofibrate Preparation in 2011 [J]. Chinese Journal of Pharmacovigilance, 2013, 10(5): 272-275.
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