Description

Spironolactone Ep Impurity A is a high-purity reference standard used for analytical and quality control purposes in pharmaceutical development and manufacturing. This compound is critical for ensuring the safety and efficacy of Spironolactone, a widely used steroidal anti-mineralocorticoid, by accurately identifying and quantifying this specific impurity. It is an essential material for analytical chemists, quality assurance professionals, and researchers in pharmaceutical companies, contract research organizations (CROs), and regulatory testing laboratories.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material (CRM) for the identification and quantification of Spironolactone Ep Impurity A in active pharmaceutical ingredient (API) batches.
• Method Development and Validation: Serves as a critical standard for developing and validating analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and related techniques.
• Quality Control (QC) and Quality Assurance (QA): Employed in routine QC testing to monitor impurity levels and ensure compliance with pharmacopeial standards (e.g., USP, EP, ICH guidelines).
• Stability Studies: Used to track the formation of this specific degradation product during drug substance and drug product stability testing under various conditions.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., ANDA, NDA) to demonstrate control over the impurity profile of Spironolactone.
• Research and Development: Facilitates research into the degradation pathways and chemical behavior of Spironolactone during synthesis and formulation.

Basic Information

Item	Detail
Product Name	Spironolactone Ep Impurity A
CAS No.	132458-33-4
Molecular Formula	C24H30O4S
Molecular Weight	414.56 g/mol
Synonyms	7α-(Acetylthio)-3-oxo-17α-pregn-4-ene-21,17-carbolactone; 7α-Acetylthio-3-oxo-17α-pregn-4-ene-21,17-carbolactone; Spironolactone Impurity A (EP); Spironolactone Related Compound A; 17-Hydroxy-7α-mercapto-3-oxo-17α-pregn-4-ene-21-carboxylic acid γ-lactone 7-acetate; Canrenone 7α-acetate; 7α-Acetylthio-canrenone
EINECS	Contact for details

Quality Control

Our Spironolactone Ep Impurity A is manufactured under strict quality systems to ensure it meets the exacting standards required for pharmaceutical reference materials. Each batch is subjected to comprehensive analytical testing, including identification by spectroscopic methods (IR, NMR, MS), purity determination by HPLC, and control of related substances. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing all test results and confirming compliance with relevant pharmacopeial monographs (EP, USP) and ICH Q3A/B guidelines.

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); ensure the container is sealed tightly after each use to prevent absorption of atmospheric moisture. For long-term storage, consider storing under an inert atmosphere.

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)	Individual unknown impurity: ≤ 0.5% 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.