Description

Spironolactone Ep Impurity G CAS NO 880106-10-5 is a high-purity reference standard and pharmaceutical impurity used for analytical and quality control purposes. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of the active pharmaceutical ingredient (API) Spironolactone. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in drug development, quality assurance, and method validation.

Application

• Pharmaceutical Impurity Profiling and Control: Used as a certified reference material for the identification and quantification of impurities in Spironolactone API and finished drug products.
• Analytical Method Development and Validation: Serves as a critical standard for developing, calibrating, and validating HPLC, UPLC, and LC-MS methods in compliance with ICH guidelines.
• Quality Assurance/Quality Control (QA/QC): Essential for routine batch testing to monitor impurity levels and ensure product specifications are met for regulatory filings (e.g., FDA, EMA).
• Stability Studies: Employed to track the formation of degradation products in Spironolactone formulations under various stress conditions.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research and Development: Used in academic and industrial R&D to study the metabolism, degradation pathways, and synthesis of Spironolactone-related compounds.

Basic Information

Product Name	Spironolactone Ep Impurity G
CAS No.	880106-10-5
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; Spironolactone Impurity G (EP); Spironolactone Related Compound G; 7α-Acetylthio-17α-hydroxy-3-oxopregn-4-ene-21-carboxylic acid γ-lactone; 7α-Acetylthio-17α-hydroxy-3-oxo-4-pregnen-21-carboxylic acid γ-lactone; 7α-Acetylthio-17α-hydroxy-3-oxo-4-pregnene-21-carboxylic acid γ-lactone
EINECS	Contact for details

Quality Control

Every batch of Spironolactone Ep Impurity G is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity testing using advanced analytical techniques (HPLC, GC, NMR, MS) to ensure compliance with pharmacopeial standards (EP, USP) and ICH Q3A/B guidelines. A comprehensive Certificate of Analysis (COA) detailing batch-specific results 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. For long-term storage, consider storing at 2-8°C. The material is hygroscopic (moisture-sensitive); ensure the container is sealed tightly after each use to prevent moisture absorption.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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