Description

Desmethyl Cerivastatin, Sodium Salt is a key pharmaceutical intermediate and reference standard derived from the statin family of compounds. This high-purity compound is essential for research, development, and quality control processes in the pharmaceutical industry. It is primarily utilized by manufacturers and research institutions focused on cardiovascular drug development, analytical method validation, and metabolic studies.

Application

• Pharmaceutical Reference Standard: Used for the qualitative and quantitative analysis of cerivastatin and related metabolites in drug substances and finished products.
• Active Pharmaceutical Ingredient (API) Intermediate: Serves as a critical synthetic building block in the production pathway for statin-based medications.
• Metabolic Pathway Research: Employed in in vitro and in vivo studies to investigate the pharmacokinetics, pharmacodynamics, and biotransformation of cerivastatin.
• Analytical Method Development: Acts as a known impurity or degradation product for developing and validating stability-indicating HPLC, LC-MS, or other chromatographic methods.
• Biochemical Research: Used in enzymatic assays to study HMG-CoA reductase inhibition and related cholesterol biosynthesis pathways.
• Quality Control & Assurance: Critical for ensuring batch-to-batch consistency, purity profiling, and regulatory compliance in pharmaceutical manufacturing.

Basic Information

Product Name	Desmethyl Cerivastatin, Sodium Salt
CAS No.	157199-28-5
Molecular Formula	C₂₂H₂₇FNNaO₅
Molecular Weight	427.45 g/mol
Synonyms	3,5-Dihydroxy-7-[4-(4-fluorophenyl)-2-(1-methylethyl)-5-(N-methylcarbamoyl)-1H-pyrrol-1-yl]hept-6-enoic Acid Sodium Salt; Sodium Desmethyl Cerivastatin; Cerivastatin Impurity; Cerivastatin Related Compound; Bay w 6228 Impurity; (E)-7-[4-(4-Fluorophenyl)-5-[(methylcarbamoyl)methyl]-2-isopropyl-1H-pyrrol-1-yl]-3,5-dihydroxyhept-6-enoic Acid Sodium Salt; (3R,5S)-7-[4-(4-Fluorophenyl)-2-isopropyl-5-[(methylcarbamoyl)methyl]-1H-pyrrol-1-yl]-3,5-dihydroxyhept-6-enoic Acid Sodium Salt
EINECS	Contact for details

Quality Control

Our Desmethyl Cerivastatin, Sodium Salt is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, residual solvent analysis, and identity confirmation (IR, MS). We provide full traceability and Certificates of Analysis (COA) that detail all test results against stringent in-house specifications, supporting compliance with cGMP and ICH guidelines for pharmaceutical intermediates.

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 should be handled in a low-humidity environment 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
Purity (HPLC)	≥ 98.0%
Water Content (KF)	≤ 2.0%
Residual Solvents (GC)	Meets ICH Q3C guidelines
Heavy Metals	≤ 20 ppm
Assay (on anhydrous basis)	97.0% - 103.0%

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