Description

Dexamethasone Sodium Phosphate Ep Impurity H CAS NO 162968-22-1 is a high-purity reference standard specifically identified as an impurity of Dexamethasone Sodium Phosphate. This compound is critical for analytical method development, validation, and quality control in pharmaceutical manufacturing. It is primarily required by analytical laboratories, quality assurance departments, and regulatory affairs teams within the global pharmaceutical and biotechnology sectors to ensure the purity, safety, and efficacy of corticosteroid-based drug products.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of Impurity H in Dexamethasone Sodium Phosphate active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating sensitive and specific chromatographic methods, such as HPLC and UPLC, to monitor impurities.
• Quality Control & Batch Release Testing: Used in routine QC testing to confirm that impurity levels are within the strict limits specified in pharmacopeial monographs (EP, USP, etc.).
• Stability Studies: Employed as an analytical marker to track the formation of degradation products in stability testing of drug substances and products under various ICH conditions.
• Regulatory Compliance & Submissions: Supports the preparation of regulatory documentation (e.g., CMC sections for FDA, EMA) by providing characterized impurity profiles.
• Research & Development: Utilized in R&D to understand the degradation pathways and impurity formation mechanisms of Dexamethasone Sodium Phosphate.

Basic Information

Product Name	Dexamethasone Sodium Phosphate Ep Impurity H
CAS No.	162968-22-1
Molecular Formula	C22H28FNa2O8P
Molecular Weight	516.39 g/mol
Synonyms	9-Fluoro-11β,17,21-trihydroxy-16α-methylpregna-1,4-diene-3,20-dione 21-(Disodium Phosphate); Dexamethasone Sodium Phosphate Related Compound H; Dexamethasone 21-Phosphate Disodium Salt Impurity H; Dexamethasone Impurity H (Sodium Phosphate); 16α-Methyl-9α-fluoro-1,4-pregnadiene-11β,17α,21-triol-3,20-dione 21-(Disodium Phosphate); Dexamethasone 21-Phosphate Disodium EP Impurity H
EINECS	Contact for details

Quality Control

This high-grade reference standard is manufactured and controlled under a strict quality management system. Each batch is comprehensively characterized using advanced spectroscopic and chromatographic techniques to confirm identity and purity, aligning with pharmacopeial expectations (EP, USP). A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results for assay, related substances, residual solvents, and other critical parameters to ensure traceability and reliability for your regulatory needs.

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 degradation due to moisture absorption.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference
Assay (HPLC)	≥ 95.0%
Purity (HPLC, Area %)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.