Description

Dexamethasone Impurity 10 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 research institutions involved in method development, stability studies, and impurity profiling. The availability of this well-characterized impurity standard is essential for meeting stringent pharmacopeial requirements and maintaining robust quality control systems.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Dexamethasone API and finished drug products.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating chromatographic methods (HPLC, UPLC) for impurity separation and detection.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to monitor and control impurity levels, ensuring compliance with ICH guidelines and pharmacopeial monographs (USP, EP, JP).
• Stability Studies: Used to track the formation and growth of this specific impurity under various stress conditions (heat, light, humidity) as part of drug stability profiling.
• Regulatory Submissions: Provides necessary data and characterization for regulatory filings (e.g., ANDA, NDA, CTA) to demonstrate thorough impurity understanding and control.
• Research & Development: Serves as a key intermediate or degradation product for studying the synthesis pathway, metabolism, and degradation mechanisms of dexamethasone.

Basic Information

Product Name	Dexamethasone Impurity 10
CAS No.	37926-77-5
Molecular Formula	C22H29FO5
Molecular Weight	392.46 g/mol
Synonyms	9α-Fluoro-11β,17α,21-trihydroxy-16α-methylpregna-1,4-diene-3,20-dione; 16α-Methyl-9α-fluoroprednisolone; Dexamethasone related compound; Dexamethasone EP Impurity; Dexamethasone USP Impurity; Dexamethasone Degradant; Dexamethasone Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Dexamethasone Impurity 10 is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical characterization using advanced techniques such as HPLC, GC, NMR, and MS to confirm identity, purity, and structure. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with relevant standards. We support regulatory needs with full traceability and documentation.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing at 2-8°C. The material is light-sensitive and should be handled under appropriate conditions to prevent degradation.

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)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
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.