Description

6-Epi Pravastatin, Sodium Salt is a key stereoisomer of the well-known cholesterol-lowering agent, Pravastatin. This compound is of significant interest in pharmaceutical research and development, particularly for metabolic studies and as a reference standard in analytical chemistry. It is primarily utilized by research institutions, pharmaceutical manufacturers, and analytical laboratories engaged in drug discovery, impurity profiling, and quality control processes for statin-based therapeutics.

Application

• Pharmaceutical Reference Standard: Used as a high-purity certified reference material (CRM) for the identification and quantification of the 6-Epi isomer in Pravastatin sodium active pharmaceutical ingredient (API) and finished dosage forms.
• Metabolic Pathway Research: Serves as a critical tool in studying the biotransformation, pharmacokinetics, and metabolic stability of pravastatin and related HMG-CoA reductase inhibitors.
• Impurity Profiling and Control: Essential for developing and validating analytical methods (e.g., HPLC, LC-MS) to monitor and control this specific stereoisomeric impurity during API synthesis and manufacturing, ensuring compliance with ICH guidelines.
• Drug Discovery & Development: Employed in preclinical research to investigate the structure-activity relationships (SAR) of statin analogs and to explore potential new therapeutic applications.
• Quality Assurance/Quality Control (QA/QC): Used by quality control laboratories to calibrate instruments and verify the accuracy of assay methods for pravastatin sodium batches.

Basic Information

Product Name	6-Epi Pravastatin, Sodium Salt
CAS No.	81176-41-2
Molecular Formula	C₂₃H₃₅NaO₇
Molecular Weight	446.52 g/mol
Synonyms	6-Epi Pravastatin Sodium; (3R,5R)-7-[(1S,2S,6S,8S,8aR)-6-Hydroxy-2-methyl-8-{[(2S)-2-methylbutanoyl]oxy}-1,2,6,7,8,8a-hexahydronaphthalen-1-yl]-3,5-dihydroxyheptanoic Acid Sodium Salt; Pravastatin EP Impurity C Sodium Salt; Pravastatin Sodium EP Impurity C; 6-Epi Pravastatin Sodium Salt; Sodium (3R,5R)-7-[(1S,2S,6S,8S,8aR)-6-hydroxy-2-methyl-8-{[(2S)-2-methylbutanoyl]oxy}-1,2,6,7,8,8a-hexahydronaphthalen-1-yl]-3,5-dihydroxyheptanoate
EINECS	Contact for details

Quality Control

Our 6-Epi Pravastatin, Sodium Salt is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (IR, NMR), to ensure it meets the high standards required for pharmaceutical research and reference standards. Certificates of Analysis (COA) with detailed chromatographic data are provided and can be tailored to meet specific pharmacopeial requirements (e.g., USP, EP).

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 should be handled in a controlled environment to minimize exposure to atmospheric humidity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%
Heavy Metals	≤ 20 ppm
Specific Optical Rotation	Contact for details

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