Description

Eplerenone Impurity 19 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, a selective aldosterone receptor antagonist. 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 and finished drug products.
• Analytical Method Development & Validation: Serves as a critical standard for developing and validating HPLC, UPLC, or GC methods to monitor impurity levels during manufacturing.
• Quality Control & Assurance (QC/QA): Essential for in-process testing and release testing of Eplerenone batches to ensure they meet pharmacopeial specifications (e.g., USP, EP).
• Stability Studies: Employed to track the formation of this impurity over time under various storage conditions, supporting drug shelf-life determination.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Development: Used in synthetic chemistry research to study the degradation pathways and metabolism of Eplerenone.

Basic Information

Product Name	Eplerenone Impurity 19
CAS No.	209253-73-6
Molecular Formula	C24H30O6
Molecular Weight	414.50 g/mol
Synonyms	9α,11α-Epoxy-7α-(methoxycarbonyl)-3-oxo-17α-pregn-4-ene-21,17-carbolactone; 9,11α-Epoxy-7α-(methoxycarbonyl)-3-oxo-17α-pregn-4-ene-21,17-carbolactone; Eplerenone Related Compound; Eplerenone EP Impurity; Eplerenone Process Impurity; Eplerenone Degradant
EINECS	Contact for details

Quality Control

Our Eplerenone Impurity 19 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity determination, spectroscopic identification (IR, NMR, MS), and residual solvent analysis to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) with batch-specific data is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing under inert atmosphere to prevent potential degradation.

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 unknown impurity ≤ 0.5% Total impurities ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
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.