Description

Eplerenone Impurity 7 is a designated reference standard used in the pharmaceutical development 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 analytical testing. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method validation, stability studies, and impurity profiling.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of related substances in Eplerenone API and finished dosage forms.
• Analytical Method Development & Validation (HPLC/LC-MS): Essential for developing, calibrating, and validating chromatographic methods to monitor impurity levels.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to ensure compliance with pharmacopeial specifications (e.g., USP, EP, ICH guidelines).
• Stability Studies: Used to track the formation and growth of this specific impurity under various storage conditions over time.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDA).
• Research & Development: Aids in understanding the degradation pathways and synthesis impurities of Eplerenone during process optimization.

Basic Information

Product Name	Eplerenone Impurity 7
CAS No.	192704-70-4
Molecular Formula	C24H30O6
Molecular Weight	414.49 g/mol
Synonyms	9,11α-Epoxy-7α-(methoxycarbonyl)-3-oxo-17α-pregn-4-ene-21,17-carbolactone; Eplerenone Related Compound; Eplerenone EP Impurity; Eplerenone USP Impurity; (7α,11α,17α)-9,11-Epoxy-17-hydroxy-3-oxopregn-4-ene-7,21-dicarboxylic acid 7-methyl ester γ-lactone; Eplerenone Process Impurity; Inspra Impurity
EINECS	Contact for details

Quality Control

Our Eplerenone Impurity 7 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure it meets the high-purity standards required for pharmaceutical reference materials. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profile, typically assessed by HPLC, NMR, and MS. We support compliance with ICH Q3A/B, USP, and EP guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
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.