Description

Fludrocortisone Impurity 2 is a specified impurity of the corticosteroid pharmaceutical, Fludrocortisone Acetate. This compound is critical for analytical reference and quality control processes in pharmaceutical development and manufacturing. It is primarily required by pharmaceutical companies, contract research organizations (CROs), and analytical laboratories for method validation, stability studies, and ensuring the purity and safety of the final drug product.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Fludrocortisone Acetate impurities.
• Analytical Method Development & Validation: Essential for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurity profiles.
• Quality Control & Batch Release Testing: Employed in routine QC testing of active pharmaceutical ingredients (APIs) and finished drug products to ensure compliance with ICH guidelines.
• Stability Studies: Used to track the formation of degradation products in Fludrocortisone Acetate formulations under various stress conditions.
• Regulatory Submissions: Provides necessary impurity characterization data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Development: Serves as a key intermediate or marker in synthetic pathway research and impurity synthesis studies.

Basic Information

Product Name	Fludrocortisone Impurity 2
CAS No.	124157-52-4
Molecular Formula	C21H27FO5
Molecular Weight	378.44 g/mol
Synonyms	9α-Fluoro-11β,17α,21-trihydroxypregn-4-ene-3,20-dione; 9α-Fluorohydrocortisone; 9α-Fluoro-11β,17,21-trihydroxypregn-4-ene-3,20-dione; Fludrocortisone Related Compound; Fludrocortisone EP Impurity; Fludrocortisone USP Impurity
EINECS	Contact for details

Quality Control

Our Fludrocortisone Impurity 2 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results from HPLC, NMR, and MS analyses. We support compliance with ICH Q3A/B, USP, and EP guidelines for pharmaceutical impurities.

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) and must be kept in a desiccated environment to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms to reference standard
Identification (IR)	Conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0%
Water Content (KF)	≤ 2.0%
Residual Solvents (GC)	Complies with ICH limits

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