Description

Desmethyl Hydroxy Cerivastatin, Sodium Salt is a key pharmaceutical intermediate and reference standard used in the research and development of statin-based therapeutics. This compound is critical for ensuring the quality, safety, and efficacy of analytical methods and synthesis pathways. It is primarily utilized by pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories engaged in drug development, quality control, and regulatory compliance.

Application

• Pharmaceutical Intermediate: A crucial building block in the synthesis of advanced statin molecules and related pharmacologically active compounds.
• Analytical Reference Standard: Used for method development, validation, and quality control testing (e.g., HPLC, LC-MS) in pharmaceutical analysis.
• Metabolite Studies: Serves as a reference compound for the identification and quantification of drug metabolites in pharmacokinetic and bioanalytical research.
• Impurity Profiling: Essential for characterizing and controlling related substances and degradation products in active pharmaceutical ingredient (API) batches.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., with FDA, EMA) by providing certified reference material for specification setting.
• Academic & Biomedical Research: Used in university and institutional labs for studying cholesterol biosynthesis pathways and enzyme inhibition mechanisms.

Basic Information

Product Name	Desmethyl Hydroxy Cerivastatin, Sodium Salt
CAS No.	201793-00-2
Molecular Formula	C₂₂H₂₇FNNaO₅
Molecular Weight	427.45 g/mol
Synonyms	Cerivastatin Impurity F (Sodium Salt); (3R,5S)-7-[4-(4-Fluorophenyl)-2,6-diisopropyl-5-(methoxymethyl)pyridin-3-yl]-3,5-dihydroxyhept-6-enoic Acid Sodium Salt; Sodium (E,3R,5S)-7-[4-(4-fluorophenyl)-5-(hydroxymethyl)-2,6-diisopropylpyridin-3-yl]-3,5-dihydroxyhept-6-enoate; Desmethylhydroxy Cerivastatin Sodium; BAY w 6228 Sodium Salt; ZD 4522 Sodium Salt; Cerivastatin Related Compound F Sodium Salt
EINECS	Contact for details

Quality Control

Our Desmethyl Hydroxy Cerivastatin, Sodium Salt is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, identity confirmation by spectroscopic methods (IR, NMR), and residual solvent analysis to ensure it meets stringent standards for pharmaceutical reference materials. A detailed Certificate of Analysis (COA) is provided with each shipment, confirming compliance with customer specifications.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept under inert conditions or in a desiccator after opening to maintain stability and purity.

Specification

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

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