Description

Dexamethasone Impurity 11 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient (API) dexamethasone. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of impurities in Dexamethasone API and finished drug products.
• Analytical Method Development: Serves as a critical standard for developing and validating HPLC, UPLC, and other chromatographic methods in quality control laboratories.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submissions (e.g., for FDA, EMA) that require detailed impurity characterization and control strategies.
• Stability Studies: Employed to monitor the formation of degradation products in dexamethasone formulations under various stress conditions.
• Research & Development: Used in pharmaceutical R&D to study the degradation pathways and chemical behavior of dexamethasone.
• Quality Control Testing: Acts as a system suitability standard and for routine batch release testing of dexamethasone to ensure it meets pharmacopeial specifications (USP, EP, BP).

Basic Information

Product Name	Dexamethasone Impurity 11
CAS No.	192447-02-2
Molecular Formula	C22H29FO5
Molecular Weight	392.46 g/mol
Synonyms	9α-Fluoro-11β,17α,21-trihydroxy-16α-methylpregna-1,4-diene-3,20-dione Impurity 11; Dexamethasone Related Compound 11; 16α-Methyl-9α-fluoro-1,4-pregnadiene-11β,17α,21-triol-3,20-dione Impurity; Dexamethasone EP Impurity I; Dexamethasone USP Related Compound; (11β,16α)-9-Fluoro-11,17,21-trihydroxy-16-methylpregna-1,4-diene-3,20-dione Impurity
EINECS	Contact for details

Quality Control

Every batch of Dexamethasone Impurity 11 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity testing using advanced analytical techniques such as HPLC, GC, NMR, and MS to ensure they meet the highest standards for pharmaceutical reference materials. 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 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 and purity.

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 individual impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0% w/w

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