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Product name |
Fenofibrate |
CAS NO. |
49562-28-9 |
Synonyms |
Fenofibrate |
Category | Pharmaceutical Raw Materials,Active Pharmaceutical Ingredients,Bulk Drugs,Fine Chemicals. |
Purity |
99% Fenofibrate |
Appearance |
Fenofibrate powder |
Shelf life | 2 years for Fenofibrate |
Usage |
Fenofibrate used to reduce cholesterol levels in patients at risk of cardiovascular disease. |
Storage | Fenofibrate should be stored in a well-closed container at low temperature, keep away from moisture, heat and light. |
What is fenofibrate?
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.
Product Name: Fenofibrate
CAS: 49562-28-9
Batch No. | HF160822 | Quantity | 1240kgs |
Mfg. Date | Aug. 22, 2016 | Package | As required |
Rep. Date | Aug. 25, 2016 | Exp. Date | Aug. 21, 2018 |
Items | Standards | Results | |
Appearance | White or off-white powder | Off-white powder | |
Identification | By HPLC | Complies | |
Melting Point | 120ºC~130ºC | 126ºC | |
Loss on Drying | ≤1.00% | 0.21% | |
Heavy Metals | ≤ 10ppm | Complies | |
Sulfated Ash | ≤ 0.10% | 0.03% | |
Chl orine Content | 17.5%~19.5% | 19.3% | |
Ars enic Content | ≤ 0.1ppm | 0.09ppm | |
Lead VContent | ≤ 3.0ppm | 0.50ppm | |
Cad mium Content | ≤ 0.1ppm | 0.10ppm | |
Mer cury Content | ≤ 0.1ppm | 0.10ppm | |
Microbiological Test | Coliforms:Negative | Negative | |
Salmonella: Negative | Complies | ||
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 Standard | ||
Conclusion | The product complied to USP standard. | ||
Storage | Preserve in tight,light-resistant containers in a cool place |
Application of fenofibrate
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.
Qingdao Sigma Chemical Co.,Ltd is a global chemical industry manufacturers and suppliers of pharmaceuticals and intermediates, food and feed additives, herbal extracts, agrochemicals and fine chemicals etc.
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