Description

Dexamethasone Acetate Impurity E CAS NO 1524-94-3 is a specified impurity of the corticosteroid Dexamethasone Acetate, critical for pharmaceutical quality control and regulatory compliance. This compound is essential for analytical method development, validation, and ensuring the purity and safety of the active pharmaceutical ingredient (API). It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in the development, production, and quality assurance of steroid-based medications.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Impurity E in Dexamethasone Acetate drug substance and finished products.
• Analytical Method Development: Critical for developing and validating HPLC, UPLC, or GC methods to monitor impurities in accordance with ICH Q3A and Q3B guidelines.
• Quality Control & Assurance: Serves as a system suitability standard and for routine quality control testing in pharmaceutical manufacturing to ensure batch-to-batch consistency and compliance with pharmacopoeial standards (USP, EP, BP).
• Stability Studies: Employed in forced degradation and long-term stability studies to identify and track the formation of this specific impurity over time.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough impurity profiling and control strategies.
• Research & Development: Used in academic and industrial R&D to study the degradation pathways, metabolism, and chemical behavior of Dexamethasone Acetate.

Basic Information

Product Name	Dexamethasone Acetate Impurity E
CAS No.	1524-94-3
Molecular Formula	C24H31FO6
Molecular Weight	434.50 g/mol
Synonyms	9α-Fluoro-11β,17α,21-trihydroxy-16α-methylpregna-1,4-diene-3,20-dione 21-acetate Impurity E; 16α-Methyl-9α-fluoro-1,4-pregnadiene-11β,17α,21-triol-3,20-dione 21-acetate Related Compound E; Dexamethasone 21-Acetate Impurity E; 1,4-Pregnadiene-9α-fluoro-16α-methyl-11β,17α,21-triol-3,20-dione 21-acetate Impurity; Dexamethasone Acetate EP Impurity E; Dexamethasone Acetate USP Related Compound E
EINECS	Contact for details

Quality Control

Our Dexamethasone Acetate Impurity E is manufactured and tested under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (IR, NMR), to ensure it meets the high standards required for use as a reference material. Certificates of Analysis (COA) are provided, detailing batch-specific results and confirming compliance with relevant pharmacopoeial guidelines. Our quality commitment ensures reliable and consistent performance for your critical analytical applications.

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); ensure the container is kept tightly sealed in a dry environment to prevent absorption of moisture.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
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.