Description

Spironolactone Impurity 6 is a high-purity chemical reference standard used for analytical and quality control purposes in pharmaceutical development and manufacturing. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of spironolactone, a widely prescribed medication. It is an essential tool for researchers and quality assurance professionals in pharmaceutical companies, contract research organizations (CROs), and analytical testing laboratories.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in spironolactone active pharmaceutical ingredient (API) and finished drug products.
• Method Development and Validation: Critical for developing and validating sensitive analytical methods, such as HPLC and LC-MS, to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Used in routine batch testing to ensure spironolactone meets stringent pharmacopeial specifications (e.g., USP, EP, ICH Q3A/B guidelines) for impurity limits.
• Stability Studies: Employed to track the formation of degradation products in spironolactone formulations under various stress conditions.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to demonstrate control over the manufacturing process.
• Research and Development: Supports synthetic route optimization and impurity profiling during the development of spironolactone and related compounds.

Basic Information

Item	Details
Product Name	Spironolactone Impurity 6
CAS No.	53866-23-2
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 Related Compound A (as per some pharmacopeias); 7α-Acetylthio-17α-hydroxy-3-oxopregn-4-ene-21-carboxylic acid γ-lactone; 17-Hydroxy-7α-mercapto-3-oxo-17α-pregn-4-ene-21-carboxylic acid γ-lactone acetate; Canrenone acetate; 7α-Acetylthiospironolactone
EINECS	Contact for details

Quality Control

Every batch of Spironolactone Impurity 6 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced techniques like HPLC, GC, and NMR to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. We support compliance with ICH guidelines and can supply materials suitable for use in regulated environments.

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 should be kept in a desiccated environment to maintain stability and purity. For long-term storage, consider storing under an inert atmosphere.

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)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
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.