Description

Dexamethasone EP Impurity K is a high-purity reference standard used for analytical and quality control purposes in pharmaceutical development and manufacturing. This compound is critical for ensuring the safety and efficacy of dexamethasone-based drug products by enabling the accurate identification and quantification of this specific impurity. It is an essential material for analytical chemists and quality assurance professionals working in pharmaceutical R&D, quality control laboratories, and regulatory affairs.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Dexamethasone EP Impurity K in active pharmaceutical ingredients (APIs) and finished drug products.
• Method Development and Validation: Crucial for developing, validating, and transferring analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and Ultra-High-Performance Liquid Chromatography (UPLC) methods.
• Quality Control and Batch Release: Used in routine QC testing to monitor impurity profiles and ensure dexamethasone batches comply with pharmacopeial specifications (e.g., EP, USP).
• Stability Studies: Employed to track the formation of this impurity over time under various stress conditions, supporting drug shelf-life determination.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., CMC sections for FDA, EMA) by providing definitive impurity characterization data.
• Research and Development: Facilitates impurity profiling during synthetic route development and process optimization for dexamethasone API manufacturing.

Basic Information

Product Name	Dexamethasone EP Impurity K
CAS No.	1809224-82-5
Molecular Formula	C22H29FO5
Molecular Weight	392.46 g/mol
Synonyms	9-Fluoro-11β,17,21-trihydroxy-16α-methylpregna-1,4-diene-3,20-dione Impurity K; Dexamethasone Related Compound K; (11β,16α)-9-Fluoro-11,17,21-trihydroxy-16-methylpregna-1,4-diene-3,20-dione Impurity; Dexamethasone Process Impurity K; European Pharmacopoeia Dexamethasone Impurity K
EINECS	Contact for details

Quality Control

Every batch of Dexamethasone EP Impurity K is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assay, and impurity profiling using advanced techniques like HPLC and NMR to ensure it meets the exacting standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment, supporting compliance with cGMP and relevant pharmacopeial guidelines (EP/USP).

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); ensure the container is sealed tightly after each use to prevent absorption of atmospheric moisture, which could affect stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown 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.