Description

2,3-Dehydroxy Atorvastatin Sodium Salt is a key pharmaceutical intermediate and impurity standard used in the development and quality control of statin-based cholesterol-lowering medications. This compound is critical for ensuring the purity, safety, and efficacy of active pharmaceutical ingredients (APIs) like Atorvastatin. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions engaged in drug development, regulatory compliance testing, and metabolic studies.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for HPLC, LC-MS, and other analytical methods to quantify and control related substances in Atorvastatin API and finished dosage forms.
• Drug Metabolism & Pharmacokinetics (DMPK) Research: Used as a metabolite analog or internal standard in studies investigating the metabolic pathways and pharmacokinetic profiles of statin drugs.
• Process Chemistry & Development: Employed as an intermediate or a marker in the research, optimization, and scale-up of synthetic routes for Atorvastatin and its analogs.
• Quality Assurance/Quality Control (QA/QC): Essential for method validation, system suitability tests, and ensuring batch-to-batch consistency in pharmaceutical manufacturing under GMP guidelines.
• Regulatory Compliance & Filing: Critical for preparing regulatory submission documents (e.g., for FDA, EMA) that require detailed impurity profiling and identification.
• Academic & Clinical Research: Utilized in university and institutional research projects focused on cardiovascular disease, lipid metabolism, and the mechanism of action of HMG-CoA reductase inhibitors.

Basic Information

Product Name	2,3-Dehydroxy Atorvastatin Sodium Salt
CAS No.	1105067-93-3
Molecular Formula	C33H33FN2NaO5
Molecular Weight	579.62 g/mol
Synonyms	Atorvastatin 2,3-Dehydroxy Sodium Salt; Atorvastatin Impurity Sodium Salt; (3R,5R)-7-[2-(4-Fluorophenyl)-5-(1-methylethyl)-3-phenyl-4-(phenylcarbamoyl)-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoic Acid Sodium Salt; 2,3-Didehydroxy Atorvastatin Sodium; Atorvastatin Related Compound Sodium Salt; Sodium (3R,5R)-7-[2-(4-fluorophenyl)-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)pyrrol-1-yl]-3,5-dihydroxyheptanoate
EINECS	Contact for details

Quality Control

Our 2,3-Dehydroxy Atorvastatin Sodium Salt is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity assay, related substance profiling, and identity confirmation (IR, MS, NMR) to ensure it meets the high standards required for pharmaceutical analysis and research. Certificates of Analysis (COA) with detailed chromatographic data are provided to support your regulatory and quality needs.

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 dry, inert conditions to maintain stability and purity. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single impurity ≤ 1.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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