Description

Mevastatin Hydroxy Acid T-Butylamine Salt is a key intermediate and reference standard in pharmaceutical research and development. This compound is of significant commercial importance for its role in the synthesis and analytical profiling of statin-class cholesterol-lowering agents. It is primarily utilized by pharmaceutical manufacturers, contract research organizations (CROs), and academic institutions engaged in metabolic disorder research. The material is supplied to meet the stringent purity requirements of advanced pharmaceutical applications.

Application

• Pharmaceutical Intermediate: A critical building block in the synthetic pathways for statin analogs and related active pharmaceutical ingredients (APIs).
• Analytical Reference Standard: Used for method development, validation, and quality control (QC) testing in HPLC, LC-MS, and other chromatographic systems.
• Biochemical Research: Serves as a tool compound for studying HMG-CoA reductase inhibition, cholesterol biosynthesis, and other metabolic pathways in vitro.
• Process Development & Scale-Up: Employed in optimizing fermentation, extraction, and purification processes for statin production.
• Impurity Profiling: Acts as a certified standard for identifying and quantifying related substances and degradation products in mevastatin and similar APIs.

Basic Information

Product Name	Mevastatin Hydroxy Acid T-Butylamine Salt
CAS No.	262285-80-3
Molecular Formula	C26H43NO6 • C4H11N
Molecular Weight	521.70 g/mol
Synonyms	Mevastatin Hydroxy Acid tert-Butylamine Salt; (3R,5R)-7-[(1S,2S,6S,8S,8aR)-8-Hydroxy-2-methyl-1,2,6,7,8,8a-hexahydronaphthalen-1-yl]-3,5-dihydroxyheptanoic Acid tert-Butylamine Salt; Compactin Hydroxy Acid TBA Salt; ML-236B Hydroxy Acid tert-Butylamine Salt; Mevastatin Open Acid T-Butylamine Salt; Mevastatin Acid TBA Salt; 6α-Methylcompactin Hydroxy Acid tert-Butylamine Salt
EINECS	Contact for details

Quality Control

Our Mevastatin Hydroxy Acid T-Butylamine 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 the high standards required for pharmaceutical research. Certificates of Analysis (COA) with detailed chromatograms and spectral data are provided to guarantee traceability and batch-to-batch consistency.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥98.0%
Related Substances (HPLC)	Total impurities ≤2.0% Any single unknown impurity ≤0.5%
Water Content (KF)	≤1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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