Stéroïdes et Dérivés

Atorvastatin impurity F is an impurity that can be found in atorvastatin. It is a white to off-white crystalline solid with a melting point of 142°C. It has a molecular weight of 273.5 and chemical formula of C14H13N3O2. This impurity can be found in atorvastatin as an API impurity, which may have an effect on the efficacy or toxicity of the drug product. Impurities are present in all pharmaceutical products and should be identified, characterized, and quantified for quality control purposes. Impurities are often unavoidable byproducts of the manufacturing process and can lead to potential safety concerns if they are not detected early on during drug development. The presence of impurities may also affect the pharmacological effects or therapeutic efficacy of the drug product.

Atorvastatin methyl ester is a statin drug that inhibits the synthesis of cholesterol and other lipids in the body. It is used to reduce high levels of low-density lipoprotein (LDL) cholesterol, which may lead to heart disease or stroke. Atorvastatin methyl ester has been shown to be effective in reducing the uptake of LDL cholesterol into cells by preventing the formation of LDL particles. This drug also decreases the production of biphosphate-containing phospholipids, which are essential for dendritic cell maturation. The crystalline polymorphs have been characterized by X-ray diffraction and microscopy. Impurities can be detected using ultraviolet spectroscopy, infrared spectroscopy, or nuclear magnetic resonance spectroscopy.

Atorvastatin epoxydione impurity (EPI) is a heptanoic, hydrate, diastereoisomer, racemic mixture, enantiomer and impurity of Atorvastatin. The EPI has been minimized in the formulation process by using a novel synthesis route that employs a chiral pyrrole derivative as an intermediate. This minimization has allowed for the elimination of the tautomer and other impurities present in the original compound.