Description

6-Epi Pravastatin Lactonediscontinued is a key pharmaceutical intermediate and reference standard, specifically the 6-epimer of the pravastatin lactone form. This compound is of significant value in analytical research and quality control processes within the pharmaceutical development sector. It is primarily utilized by research institutions, analytical laboratories, and manufacturers involved in the synthesis and quality assurance of statin-based active pharmaceutical ingredients (APIs).

Application

• Pharmaceutical Reference Standard: Serves as a critical certified reference material (CRM) for the identification, purity assessment, and quantification of pravastatin and related compounds in analytical methods like HPLC and LC-MS.
• Metabolite Research: Used in pharmacokinetic and metabolic studies to understand the biotransformation pathways of pravastatin and its epimeric forms.
• Process Impurity Profiling: Essential for monitoring and controlling the 6-epimer as a potential impurity during the manufacturing and stability testing of pravastatin sodium API.
• Method Development & Validation: A vital component in developing and validating robust analytical procedures for statin drugs to meet regulatory requirements (ICH guidelines).
• Academic & Institutional Research: Supports fundamental chemical and pharmacological research on HMG-CoA reductase inhibitors and their stereoisomers.

Basic Information

Product Name	6-Epi Pravastatin Lactonediscontinued
CAS No.	85956-23-6
Molecular Formula	C23H34O7
Molecular Weight	422.52 g/mol
Synonyms	6-Epi Pravastatin Lactone; (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 δ-Lactone; Pravastatin 6-Epimer Lactone; 6-Epimer of Pravastatin Lactone; 6-Epi Pravastatin Lactone Form; 6-Epi Pravastatin δ-Lactone
EINECS	Contact for details

Quality Control

Our 6-Epi Pravastatin Lactonediscontinued is produced and handled under strict quality management protocols. Each batch undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation (IR, NMR), to ensure it meets the high standards required for reference materials and pharmaceutical intermediates. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting batch-specific results.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). The product is light-sensitive and should be handled under appropriate conditions to maintain stability.

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%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 0.5% w/w
Residue on Ignition	≤ 0.1%

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