Description

Epi Lovastatin Hydroxy Acid Sodium Salt is a key pharmaceutical intermediate and reference standard derived from the statin family of compounds. This high-purity substance is critical for research, development, and quality control processes in the manufacture of cholesterol-lowering medications. It is primarily utilized by pharmaceutical manufacturers, analytical laboratories, and research institutions engaged in metabolic disorder studies and generic drug development.

Application

• Pharmaceutical Intermediate: Serves as a crucial building block in the synthesis of advanced statin-based active pharmaceutical ingredients (APIs).
• Analytical Reference Standard: Used for method development, validation, and quality control (QC) testing in HPLC, LC-MS, and other chromatographic assays.
• Metabolic Research: Employed in biochemical and pharmacological studies to investigate HMG-CoA reductase inhibition and cholesterol biosynthesis pathways.
• Impurity Profiling: Acts as a specified impurity or degradation product standard for stability testing and regulatory filing of lovastatin and related drugs.
• Generic Drug Development: Essential for demonstrating bioequivalence and meeting regulatory requirements for abbreviated new drug applications (ANDAs).

Basic Information

Product Name	Epi Lovastatin Hydroxy Acid Sodium Salt
CAS No.	101400-30-0
Molecular Formula	C24H37NaO6
Molecular Weight	444.54 g/mol
Synonyms	(3R,5R)-7-[(1S,2S,6R,8S,8aR)-8-Hydroxy-2-methyl-1,2,6,7,8,8a-hexahydronaphthalen-1-yl]-3,5-dihydroxyheptanoic Acid Sodium Salt; Sodium (3R,5R)-Dihydroxy-7-[(1S,2S,6R,8S,8aR)-8-hydroxy-2-methyl-1,2,6,7,8,8a-hexahydronaphthalen-1-yl]heptanoate; Epi-Lovastatin Hydroxy Acid Sodium; Lovastatin EP Impurity C Sodium Salt; 6'-epi Lovastatin Hydroxy Acid Sodium Salt
EINECS	Contact for details

Quality Control

Our Epi Lovastatin Hydroxy Acid Sodium Salt is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, identity confirmation by IR and NMR, and residual solvent analysis, to ensure it meets stringent standards for pharmaceutical use. A detailed Certificate of Analysis (COA) is provided with every shipment, confirming compliance with customer specifications and relevant pharmacopeial guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity. For long-term storage, consider inert atmosphere conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (NMR)	Conforms to structure
Assay (HPLC)	≥98.0%
Related Substances (HPLC)	Total impurities ≤2.0% Any single impurity ≤0.5%
Water Content (KF)	≤5.0%
Residual Solvents (GC)	Meets ICH Q3C guidelines

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.