Fenofibrate is a drug of the fibrate class. It is mainly used to reduce cholesterol levels in patients at risk of cardiovascular disease. Like other fibrates,it reduces both lowdensity lipoprotein (LDL) and very low density lipoprotein (VLDL) levels,as well as increasing highdensity lipoprotein (HDL) levels and reducing triglycerides level. It is used alone or along with statins in the treatment of hypercholesterolemia and hypertriglyceridemia.
Fenofibrate, marketed as Tricor and under several other brand names, is a drug of the fibrate class. It is mainly used to reduce cholesterol levels in people at risk of cardiovascular disease. Like other fibrates, it reduces both low-density lipoprotein (LDL) and very low density lipoprotein (VLDL) levels, as well as increasing high-density lipoprotein(HDL) levels and reducing triglyceride levels. It is used alone or along with statins in the treatment ofhypercholesterolemia and hypertriglyceridemia.
Fenofibrate is mainly used for primary hypercholesterolemia or mixed dyslipidemia. Fenofibrate appears to decrease the risk of cardiovascular disease and possibly diabetic retinopathy in those with diabetes mellitus, and firstly indicated for the reduction in the progression of diabetic retinopathy in patients with type 2 diabetes and existing diabetic retinopathy in Australia. It also appears to be helpful in decreasing amputations of the lower legs in this same group of people. Fenofibrate also has an off-label use as an added therapy of high blood uric acid levels in people who have gout.
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Items | Standards | Results | |
外貌 | White or off-white powder | Off-white powder | |
Identification | By HPLC | 符合 | |
熔点 | 120ºC~130ºC | 126ºC | |
干燥失重 | ≤1.00% | 0.21% | |
Heavy Metals | ≤ 10ppm | 符合 | |
Sulfated Ash | ≤ 0.10% | 0.03% | |
Chlorine Content | 17.5%~19.5% | 19.3% | |
Arsenic Content | ≤ 0.1ppm | 0.09ppm | |
Lead VContent | ≤ 3.0ppm | 0.50ppm | |
Cadmium Content | ≤ 0.1ppm | 0.10ppm | |
Mercury Content | ≤ 0.1ppm | 0.10ppm | |
Microbiological Test | Coliforms:Negative | 消极的 | |
Salmonella: Negative | 符合 | ||
Total plate count: ≤1000 CFU/g | Pass | ||
Yeast&Mold: ≤50 CFU/g | Pass | ||
Related Substances | Impurity A: ≤0.30% | 0.18% | |
Other unknown impurity: ≤0.10% | 0.07% | ||
Total Impurities: ≤0.50% | 0.42% | ||
Assay | ≥ 98.0% | 99.50% | |
Reference Standard | USP 标准 |
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