Description

Spironolactone Ep Impurity H is a specified impurity used in the quality control and analytical profiling of the active pharmaceutical ingredient (API) Spironolactone. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure product purity, safety, and compliance with stringent pharmacopeial standards such as the European Pharmacopoeia (EP). It is primarily utilized in research, development, and quality assurance processes within the pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of Spironolactone-related impurities in API batches.
• Analytical Method Development & Validation: Used in developing and validating High-Performance Liquid Chromatography (HPLC) and other chromatographic methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Essential for routine testing in pharmaceutical QC laboratories to monitor impurity levels against EP, USP, or ICH guidelines.
• Stability Studies: Employed as a marker in forced degradation and long-term stability studies of Spironolactone drug products.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing impurity characterization data for health authorities like the FDA and EMA.
• Research & Development: Used in synthetic chemistry research to study degradation pathways and to synthesize impurity markers.

Basic Information

Product Name	Spironolactone Ep Impurity H
CAS No.	53866-24-3
Molecular Formula	C24H32O4S
Molecular Weight	416.58 g/mol
Synonyms	7α-Acetylthio-3-oxo-17α-pregn-4-ene-21,17-carbolactone; 7α-Acetylthio-17α-hydroxy-3-oxopregn-4-ene-21-carboxylic acid γ-lactone; 7α-(Acetylthio)-17α-hydroxy-3-oxopregn-4-ene-21-carboxylic acid γ-lactone; Spironolactone Impurity H (EP); Spironolactone Related Compound H; 7α-Acetylthio-17α-hydroxy-3-oxopregn-4-ene-21-carboxylic acid lactone; 7α-Acetylthio-17α-hydroxy-3-oxopregn-4-ene-21-carbolactone
EINECS	Contact for details

Quality Control

Our Spironolactone Ep Impurity H is manufactured under strict quality systems to ensure high purity and batch-to-batch consistency suitable for use as a reference standard. Each batch undergoes rigorous analytical testing, including HPLC for purity, identity confirmation by spectroscopic methods (IR, NMR), and residual solvent analysis. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing all test results and confirming compliance with relevant pharmacopeial 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). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent absorption of moisture.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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