Description

Eplerenone Ep Impurity B is a specified impurity of the active pharmaceutical ingredient (API) Eplerenone, a steroidal mineralocorticoid receptor antagonist. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, validation, and quality control. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure the purity, safety, and efficacy of Eplerenone drug substances and products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Eplerenone API and finished dosage forms.
• Analytical Method Development: Essential for developing and validating chromatographic methods, such as HPLC and UPLC, to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to ensure compliance with pharmacopeial specifications (e.g., USP, EP, ICH guidelines).
• Stability Studies: Used to track the formation of degradation products under various stress conditions to establish product shelf life.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Process Chemistry Research: Aids in the optimization of synthesis and purification processes to minimize impurity formation.

Basic Information

Product Name	Eplerenone Ep Impurity B
CAS No.	192704-82-8
Molecular Formula	C24H30O6
Molecular Weight	414.49 g/mol
Synonyms	9,11α-Epoxy-7α-(methoxycarbonyl)-3-oxo-17α-pregn-4-ene-21,17-carbolactone; 9α,11α-Epoxy-7α-methoxycarbonyl-3-oxo-17α-pregn-4-ene-21,17-carbolactone; Eplerenone Impurity B; Eplerenone Related Compound B; Eplerenone EP Impurity B; (7α,11α,17α)-9,11-Epoxy-17-hydroxy-3-oxopregn-4-ene-7,21-dicarboxylic acid 7-methyl ester γ-lactone; Inspra Impurity B.
EINECS	Contact for details

Quality Control

Our Eplerenone Ep Impurity B is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including identification by spectroscopic methods (IR, NMR, MS), purity determination by HPLC, and control of related substances. We provide full traceability and compliance with current guidelines for pharmaceutical impurities (ICH Q3A/B). A detailed Certificate of Analysis (COA) is supplied with every shipment, confirming identity, purity, and chromatographic profile.

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 material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Any individual impurity ≤ 1.0% Total impurities ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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