Description

Eplerenone Hydroxyacid Potassium Salt is a key pharmaceutical intermediate and reference standard with the CAS number 95716-98-6. This compound is critical for the synthesis and analytical validation of Eplerenone, a selective aldosterone receptor antagonist. It is primarily required by pharmaceutical manufacturers and research institutions engaged in the development and quality control of cardiovascular therapeutics. Our supply ensures high purity and batch-to-batch consistency for reliable production and research outcomes.

Application

• Pharmaceutical Intermediate: A crucial building block in the synthesis of the active pharmaceutical ingredient (API) Eplerenone.
• Reference Standard: Used for analytical method development, validation, and quality control testing of Eplerenone API and finished dosage forms.
• Impurity Standard: Serves as a certified reference material for identifying and quantifying related substances in compliance with ICH guidelines.
• Metabolite Studies: Employed in pharmacokinetic and metabolic pathway research for Eplerenone.
• Process Development: Utilized in the optimization and scale-up of manufacturing processes for cardiovascular drugs.
• Regulatory Submissions: Provides essential data for Drug Master Files (DMFs) and regulatory documentation for health authorities.

Basic Information

Item	Detail
Product Name	Eplerenone Hydroxyacid Potassium Salt
CAS No.	95716-98-6
Molecular Formula	C24H29KO6
Molecular Weight	452.59 g/mol
Synonyms	9,11α-Epoxy-7α-(methoxycarbonyl)-3-oxo-17α-pregn-4-ene-21,17-carbolactone Potassium Salt; 9α,11α-Epoxy-7α-methoxycarbonyl-3-oxo-17α-pregn-4-ene-21,17-carbolactone Potassium Salt; Eplerenone Hydroxy Acid K Salt; Eplerenone Potassium Salt; Eplerenone Acid Potassium Salt; Inspra Impurity F Potassium Salt; (7R,8S,9S,10R,13S,14S,17R)-10,13-Dimethyl-3,5'-dioxo-1,2,4',6,7,8,9,10,11,12,13,14,15,16-tetradecahydro-3H-spiro[cyclopenta[a]phenanthrene-17,2'-furan]-7-yl Potassium Carbonate
EINECS	Contact for details

Quality Control

Our Eplerenone Hydroxyacid Potassium Salt is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC, NMR, and mass spectrometry, to ensure identity, purity, and conformity to stringent specifications. Certificates of Analysis (COA) with detailed chromatographic data are provided for every shipment. We support compliance with cGMP, ICH Q7, and other relevant pharmaceutical guidelines for intermediates and reference standards.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept under inert atmosphere or in a desiccator after opening to maintain stability and prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥98.0%
Water Content (KF)	≤2.0%
Residue on Ignition	≤0.5%
Heavy Metals	≤20 ppm
Related Substances (HPLC)	Individual impurity ≤0.5%; Total impurities ≤2.0%

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