Description

Dexamethasone Impurity 10 is a high-purity reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient (API) dexamethasone by serving as a key marker for identification and quantification. It is essential for pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in method development, validation, and quality control processes. The availability of this well-characterized impurity supports compliance with stringent pharmacopeial standards.

Application

• Pharmaceutical Quality Control (QC): Used as a certified reference material for the identification and quantification of impurities in dexamethasone API and finished drug products.
• Analytical Method Development & Validation: Serves as a critical standard for developing and validating HPLC, UPLC, or GC methods to monitor impurity profiles.
• Stability Studies: Employed to track the formation and levels of this specific impurity during forced degradation and long-term stability testing of dexamethasone formulations.
• Regulatory Compliance & Documentation: Provides essential data for regulatory filings (e.g., ANDA, NDA) to demonstrate comprehensive impurity characterization as per ICH Q3A/B guidelines.
• Research & Development: Utilized in synthetic chemistry research to study the degradation pathways and metabolism of dexamethasone.
• Pharmacopeial Testing: Acts as a reference standard for testing against specifications in USP, EP, BP, or other international pharmacopeias.

Basic Information

Product Name	Dexamethasone Impurity 10
CAS No.	89561-92-2
Molecular Formula	C22H29FO5
Molecular Weight	392.46 g/mol
Synonyms	9α-Fluoro-11β,17α,21-trihydroxy-16α-methylpregna-1,4-diene-3,20-dione; Dexamethasone Related Compound; Dexamethasone EP Impurity; Dexamethasone USP Impurity; 16α-Methyl-9α-fluoro-1,4-pregnadiene-11β,17α,21-triol-3,20-dione; Dexamethasone Degradant; Dexamethasone Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Dexamethasone Impurity 10 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic and spectroscopic techniques, to ensure compliance with industry and pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing purity, identity, and impurity profile. We support compliance with ICH guidelines and can supply materials suitable for use under GMP conditions.

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 low-humidity environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

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 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.