Description

Eplerenone Impurity 14 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient (API) Eplerenone. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Eplerenone API batches.
• Analytical Method Development: Serves as a critical standard for developing and validating HPLC, UPLC, or LC-MS methods in quality control laboratories.
• Stability Studies: Employed to monitor the formation of degradation products in Eplerenone formulations under various stress conditions.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submissions (e.g., for FDA, EMA) that require detailed impurity characterization data.
• Research & Development: Used in R&D to study the metabolic pathways, synthesis by-products, and degradation mechanisms of Eplerenone.
• Quality Control Testing: Acts as a system suitability standard and for routine quality control testing to ensure API purity meets pharmacopeial standards (USP, EP).

Basic Information

Product Name	Eplerenone Impurity 14
CAS No.	1621954-05-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Eplerenone Related Compound 14; Eplerenone EP Impurity I; Eplerenone USP Impurity; 9α,11α-Epoxy-7α-(methoxycarbonyl)-3-oxo-17α-pregn-4-ene-21,17-carbolactone Derivative; (7R,8S,9S,10R,13S,14S,17R)-10,13-Dimethyl-3-oxo-1,2,6,7,8,9,10,11,12,13,14,15,16,17-tetradecahydro-3H-cyclopenta[a]phenanthrene-17-carboxylic Acid Methyl Ester Derivative; Eplerenone Process Impurity; Eplerenone Degradant
EINECS	Contact for details

Quality Control

Our Eplerenone Impurity 14 is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including chromatographic purity assays and spectroscopic identification, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing purity, identity, and trace analysis is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity. Handle under an inert atmosphere if necessary for prolonged manipulation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0%

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