Description

2,3-Dehydrosimvastatin Acid Sodium Salt is a key pharmaceutical intermediate and analytical reference standard. This compound is critical for research and development in the synthesis of statin-class drugs and for quality control in pharmaceutical manufacturing. It is primarily utilized by pharmaceutical companies, contract research organizations (CROs), and analytical laboratories engaged in cardiovascular drug development and impurity profiling.

Application

• Pharmaceutical Intermediate: A crucial building block in the synthesis of Simvastatin and related HMG-CoA reductase inhibitors.
• Reference Standard: Used for analytical method development, validation, and quantification of impurities in active pharmaceutical ingredient (API) batches.
• Metabolite Research: Serves as a reference compound for studying the metabolic pathways and degradation products of statin drugs.
• Process Chemistry: Employed in route scouting and optimization for the industrial-scale production of cholesterol-lowering medications.
• Quality Control & Assurance: Essential for HPLC, LC-MS, and other chromatographic assays to ensure API purity and compliance with pharmacopeial standards (e.g., USP, EP).
• Regulatory Submissions: Provides characterized material for inclusion in drug master files (DMFs) and regulatory documentation for health authorities.

Basic Information

Product Name	2,3-Dehydrosimvastatin Acid Sodium Salt
CAS No.	393825-04-2
Molecular Formula	C25H37NaO6
Molecular Weight	456.55 g/mol
Synonyms	Simvastatin Hydroxy Acid Sodium Salt, Dehydrosimvastatin Sodium Salt; Sodium (3R,5R)-7-((1S,2S,6R,8S,8aR)-8-hydroxy-2,6-dimethyl-1,2,6,7,8,8a-hexahydronaphthalen-1-yl)-3,5-dihydroxyheptanoate; 2,3-Didehydrosimvastatin Acid Sodium Salt; Simvastatin Impurity D Sodium Salt; (3R,5R)-7-[(1S,2S,6R,8S,8aR)-8-Hydroxy-2,6-dimethyl-1,2,6,7,8,8a-hexahydronaphthalen-1-yl]-3,5-dihydroxyheptanoic Acid Sodium Salt
EINECS	Contact for details

Quality Control

Our 2,3-Dehydrosimvastatin Acid Sodium Salt is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, NMR and IR for structural confirmation, and residual solvent analysis. Certificates of Analysis (COA) with detailed chromatograms are provided to ensure traceability and compliance with cGMP and ICH Q3A/B guidelines for impurities.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at 2-8°C. This product is hygroscopic (moisture-sensitive) and light-sensitive; therefore, containers must be kept sealed under inert atmosphere (nitrogen) when possible and allowed to reach room temperature before opening to prevent condensation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥98.0%
Water Content (KF)	≤2.0%
Residual Solvents (GC)	Meets ICH limits
Heavy Metals	≤20 ppm

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