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Dehydro Lovastatin

  • CAT Number DCTI-C-016
  • CAS Number 109273-98-5
  • Molecular Formula C24H34O4
  • Molecular Weight 386.53

Lovastatin hydroxy acid ammonium salt

  • CAT Number DCTI-C-015
  • CAS Number 75225-50-2
  • Molecular Formula C24H41NO6 (Ammonium Salt) C24H38O6 (Free acid)
  • Molecular Weight 439.59 (Ammonium Salt) 422.56 (Free acid)

Lovastatin related compound #6

  • CAT Number DCTI-C-017
  • CAS Number NA
  • Molecular Formula C24H34O5
  • Molecular Weight 402.53

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 ActionLovastatin 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 C24H36O5, 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.


Frequently Asked Questions

Stability testing of Lovastatin involves subjecting the drug product to various conditions to evaluate its impurity profile over time. It ensures impurity levels remain within acceptable limits throughout the product's shelf life.

Validation studies are conducted to ensure that the analytical methods used for impurity analysis in Lovastatin are accurate, precise, and reliable, enabling effective control of impurities during manufacturing.

Methanol is the solvent used when analyzing many impurities in Lovastatin.

Lovastatin impurities should be stored, at a controlled room temperature, usually between 2-8 °C.

Note: Products protected by valid patents by a manufacturer are not offered for sale in countries having patent protection. The sale of such products constitutes a patent infringement, and its liability is at the buyer's risk.

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