Description

Flumethasone Impurity 6 (9-Chloro-Flumethasone) is a key process-related impurity and reference standard used in the pharmaceutical development and quality control of Flumethasone. This compound is critical for ensuring the purity, safety, and efficacy of the final corticosteroid product through rigorous analytical testing. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method validation, stability studies, and compliance with ICH guidelines.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Flumethasone API and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating HPLC, UPLC, and LC-MS methods to monitor process impurities.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard and for routine batch release testing in GMP environments.
• Stability Studies: Employed to track impurity profiles and degradation pathways in stability-indicating assays for Flumethasone formulations.
• Regulatory Compliance & Filings: Critical for preparing regulatory documentation (e.g., for FDA, EMA) to demonstrate control over the manufacturing process.
• Research & Development (R&D): Used in synthetic chemistry research to study the metabolism and degradation of Flumethasone.

Basic Information

Product Name	Flumethasone Impurity 6 (9-Chloro-Flumethasone)
CAS No.	1355648-15-5
Molecular Formula	C22H28ClFO5
Molecular Weight	426.91 g/mol
Synonyms	9-Chloro-Flumethasone; 6α,9-Difluoro-11β,17α,21-trihydroxy-16α-methylpregna-1,4-diene-3,20-dione 9-Chloro Derivative; Flumethasone Related Compound 6; Flumethasone Impurity C; 9-Chloro-6α,9-difluoro-11β,17α,21-trihydroxy-16α-methylpregna-1,4-diene-3,20-dione; Flumethasone Chloro Impurity
EINECS	Contact for details

Quality Control

Every batch of Flumethasone Impurity 6 is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Our quality system is designed to meet the stringent requirements for pharmaceutical reference standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results for assay, related substances, and identification tests performed using validated methods (HPLC, IR, NMR).

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 product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥ 95.0%
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0%

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