General Information

Lovastatin Impurities and Lovastatin 

For evaluating the purity and safety of Lovastatin, an active pharmaceutical ingredient, Daicel Pharma offers a customized synthesis of Lovastatin impurity standards. These impurity standards include crucial compounds such as Dehydro Lovastatin, Lovastatin hydroxy acid ammonium salt, and Lovastatin related compound #6. Additionally, Daicel Pharma provides worldwide delivery options for Lovastatin impurity standards.

Lovastatin [CAS: 75330-75-5], derived from the fungus Aspergillus terreus, is a lactone metabolite with cholesterol-lowering properties and antineoplastic effects. As a member of the statin class of medications, it lowers cholesterol levels in the body.

Lovastatin: Use and Commercial Availability 

Lovastatin, marketed under the brand names, Altoprev and Mevacor, is a statin medication used to treat and prevent various conditions related to lipid levels. It treats coronary heart disease, hypercholesterolemia. It also treats heterozygous familial hypercholesterolemia in adolescent patients. Lovastatin was isolated from a strain of Aspergillus terreus.

Lovastatin Structure and Mechanism of Action

The chemical name of Lovastatin is (1S,3R,7S,8S,8aR)-8-(2-((2R,4R)-4-hydroxy-6-oxotetrahydro-2H-pyran-2-yl)ethyl)-3,7-dimethyl-1,2,3,7,8,8a-hexahydronaphthalen-1-yl (S)-2-methylbutanoate. Its chemical formula is C₂₄H₃₆O_5, and its molecular weight is approximately 404.5 g/mol.

Lovastatin is hydrolyzed to β-hydroxy acid, a HMG-CoA reduce inhibitor. It further converts HMG-CoA to mevalonate.

Lovastatin Impurities and Synthesis

In the pharmaceutical industry, the analysis and control of impurities in Lovastatin¹, a cholesterol-lowering medication, is essential to ensure its safety and efficacy. They may include related compounds and degradation products. Analytical techniques such as high-performance liquid chromatography (HPLC) and liquid chromatography (LC) help identify and quantify these impurities. Strict control measures and specifications limit the presence of Lovastatin impurities adhering to regulatory guidelines.

Daicel Pharma strictly adheres to cGMP standards and operates an analytical facility for the preparation of Lovastatin impurity standards, which include Dehydro Lovastatin, Lovastatin hydroxy acid ammonium salt, and Lovastatin related compound #6. Our Lovastatin impurity standards have a detailed Certificate of Analysis (CoA) that provides a comprehensive characterization report. This report includes data obtained through techniques, 1H NMR, 13C NMR, IR, MASS, and HPLC purity analysis². Upon request, we give additional data like 13C-DEPT. Moreover, we can synthesize unknown Lovastatin impurity standards and degradation products. Each delivery has a comprehensive characterization report, ensuring quality and transparency.