Description

Dexamethasone Ep Impurity E is a specified impurity and reference standard used in the analytical profiling of the potent corticosteroid Dexamethasone. This compound is critical for ensuring the purity, safety, and efficacy of Dexamethasone active pharmaceutical ingredients (APIs) and finished drug products. It is primarily required by pharmaceutical manufacturers, quality control laboratories, and regulatory bodies for method development, validation, and routine batch analysis.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of Dexamethasone Ep Impurity E in Dexamethasone API and formulations.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods for Dexamethasone.
• Quality Control & Batch Release: Used in routine QC testing to monitor impurity levels and ensure compliance with pharmacopeial limits (e.g., EP, USP, ICH Q3A/B).
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Development: Used in R&D to understand the degradation pathways and impurity profile of Dexamethasone.

Basic Information

Product Name	Dexamethasone Ep Impurity E
CAS No.	13209-41-1
Molecular Formula	C22H29FO5
Molecular Weight	392.46 g/mol
Synonyms	9α-Fluoro-11β,17α,21-trihydroxy-16α-methylpregna-1,4-diene-3,20-dione 17,21-diacetate; 16α-Methyl-9α-fluoro-1,4-pregnadiene-11β,17α,21-triol-3,20-dione 17,21-diacetate; Dexamethasone 17,21-Diacetate; Dexamethasone Diacetate; Dexamethasone Impurity E (EP); Dexamethasone Related Compound E; (11β,16α)-9-Fluoro-11,17,21-trihydroxy-16-methylpregna-1,4-diene-3,20-dione 17,21-diacetate
EINECS	Contact for details

Quality Control

Our Dexamethasone Ep Impurity E is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure it meets the stringent requirements for a pharmaceutical reference standard. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profile, supporting compliance with EP, USP, and ICH 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 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 reference spectrum
Identification (HPLC)	Retention time corresponds to 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.