Description

Eplerenone 7-Carboxylic Acid Impurity (CAS 209253-82-7) is a critical pharmaceutical reference standard used in the quality control and analytical development of the active pharmaceutical ingredient (API) Eplerenone. This compound serves as a key process-related impurity, essential for ensuring the purity, safety, and efficacy of the final drug product. It is primarily required by pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories involved in the development, validation, and routine testing of Eplerenone-based formulations.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Eplerenone API and finished dosage forms.
• Analytical Method Development & Validation (HPLC/LC-MS): Critical for developing and validating stability-indicating methods to monitor impurity profiles during stability studies and forced degradation.
• Quality Control & Batch Release Testing: Used in routine QC laboratories to confirm that Eplerenone batches meet stringent pharmacopeial (e.g., USP, EP) impurity limits.
• Process Chemistry Research: Employed by R&D scientists to study and optimize synthesis pathways, helping to minimize the formation of this specific impurity.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate comprehensive impurity characterization and control strategies.

Basic Information

Item	Detail
Product Name	Eplerenone 7-Carboxylic Acid Impurity
CAS No.	209253-82-7
Molecular Formula	C23H30O6
Molecular Weight	402.48 g/mol
Synonyms	7-Carboxy Eplerenone; 9,11α-Epoxy-7α-(methoxycarbonyl)-3-oxo-17α-pregn-4-ene-21,17-carbolactone; Eplerenone 7-Carboxylic Acid; Eplerenone Acid Impurity; Eplerenone Related Compound A; 7α-Methoxycarbonyl-3-oxo-17α-pregn-4-ene-21,17-carbolactone-9,11α-epoxide; Eplerenone Impurity A
EINECS	Contact for details

Quality Control

Every batch of Eplerenone 7-Carboxylic Acid Impurity is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC purity assay, related substance profiling, and identity confirmation (IR, NMR) to ensure compliance with pharmaceutical reference standard requirements. A comprehensive Certificate of Analysis (COA) detailing all test results and methods is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. This compound is hygroscopic (moisture-sensitive); ensure the container is sealed after each use to prevent degradation from atmospheric moisture.

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)	≤ 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.