Description

Dexamethasone Impurity 6 is a specified impurity and degradation product of the potent synthetic glucocorticoid, Dexamethasone. This compound is critical for pharmaceutical research and development, serving as a certified reference standard for analytical method development, validation, and quality control. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure the purity, safety, and efficacy of Dexamethasone drug substances and products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Dexamethasone API and finished dosage forms.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, and other chromatographic methods to monitor impurities during stability studies.
• Quality Control & Assurance: A key component in routine QC testing to ensure Dexamethasone batches comply with pharmacopeial limits (e.g., USP, EP, ICH Q3B) for specified impurities.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides necessary impurity data for Drug Master Files (DMFs), Investigational New Drug (IND), and New Drug Application (NDA) submissions to agencies like the FDA and EMA.
• Research & Development: Used in studies to understand the degradation pathways and chemical behavior of Dexamethasone.

Basic Information

Item	Details
Product Name	Dexamethasone Impurity 6
CAS No.	2964-81-0
Molecular Formula	C22H29FO5
Molecular Weight	392.46 g/mol
Synonyms	9-Fluoro-11β,17,21-trihydroxy-16α-methylpregna-1,4-diene-3,20-dione; 16α-Methyl-9α-fluoro-1,4-pregnadiene-11β,17α,21-triol-3,20-dione; Dexamethasone Related Compound B (USP); Dexamethasone EP Impurity B; Dexamethasone Impurity B; 1,4-Pregnadiene-9-fluoro-11β,17,21-triol-3,20-dione, 16α-methyl-; Dexamethasone 16α,17α-Acetonide Impurity
EINECS	Contact for details

Quality Control

Our Dexamethasone Impurity 6 is manufactured under strict quality systems. Each batch undergoes comprehensive analytical testing, including identification by spectroscopic methods (IR, NMR, MS), purity determination by HPLC, and control of related substances. We provide full traceability and a comprehensive Certificate of Analysis (COA) with each shipment, detailing batch-specific results. The material is suitable for use as a reference standard in compliance with ICH, USP, and EP 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). This product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccant use.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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