Description

Eplerenone Impurity 13 (Eplerenone Ep Impurity F) is a designated pharmaceutical reference standard used for the analytical profiling and quality control of the active pharmaceutical ingredient (API) Eplerenone. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by serving as a benchmark in chromatographic analysis. It is an essential material for pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) departments, and regulatory compliance teams involved in the development and manufacturing of cardiovascular medications.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the identification and quantification of Eplerenone Impurity F in API batches.
• Method Development and Validation: Critical for developing, optimizing, and validating analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and Ultra-Performance Liquid Chromatography (UPLC).
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to monitor impurity levels and ensure compliance with strict pharmacopeial specifications (e.g., USP, EP, ICH Q3A/B).
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., CMC sections for FDA, EMA) by providing characterized impurity data.
• Stability Studies: Employed to track the formation and growth of this specific degradation product under various stress conditions.
• Research and Development: Facilitates impurity isolation, characterization, and toxicological studies during drug development.

Basic Information

Product Name	Eplerenone Impurity 13 (Eplerenone Ep Impurity F)
CAS No.	579484-30-3
Molecular Formula	C24H30O6
Molecular Weight	414.50 g/mol
Synonyms	Eplerenone Impurity F; Eplerenone EP Impurity F; Eplerenone Related Compound F; (7α,11α,17α)-9,11-Epoxy-17-hydroxy-3-oxopregn-4-ene-7,21-dicarboxylic Acid, γ-Lactone, Methyl Ester; Pregn-4-ene-7,21-dicarboxylic Acid, 9,11-epoxy-17-hydroxy-3-oxo-, γ-lactone, Methyl Ester, (7α,11α,17α)-; Eplerenone Process Impurity; Inspra Impurity F
EINECS	Contact for details

Quality Control

Our Eplerenone Impurity 13 is manufactured under strict quality systems to ensure batch-to-batch consistency and reliability for critical analytical applications. Each lot is characterized and released with a comprehensive Certificate of Analysis (COA) that includes data from multiple orthogonal techniques. We adhere to relevant industry guidelines, including ICH Q3A/B for impurities and general pharmacopeial principles. Certificates of Analysis (COA) are available upon request and with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). Keep the container in a dry environment to prevent moisture uptake. For long-term storage, consider storing under inert atmosphere.

Specification

Item	Specification
Appearance	White to Off-white Solid
Identification (IR)	Conforms to Reference Spectrum
Identification (HPLC)	Retention time corresponds to reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total Impurities: ≤ 2.0% Any Individual Unknown Impurity: ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5% w/w

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