Description

Dexamethasone Sodium Phosphate Ep Impurity B is a critical reference standard and impurity used in the pharmaceutical quality control process. This compound is essential for ensuring the purity, safety, and efficacy of Dexamethasone Sodium Phosphate, a widely used corticosteroid. It is primarily required by analytical laboratories and pharmaceutical manufacturers for method development, validation, and routine batch testing. The availability of a well-characterized impurity standard is fundamental for compliance with stringent pharmacopeial monographs, including the European Pharmacopoeia (EP).

Application

• Primary use as a pharmacopeial reference standard for the European Pharmacopoeia (EP) and other international monographs.
• Critical component in HPLC and related chromatographic methods for the identification and quantification of impurities in Dexamethasone Sodium Phosphate API and finished drug products.
• Essential for analytical method development and validation in pharmaceutical R&D and quality control laboratories.
• Used in stability studies to monitor degradation profiles and establish shelf-life for corticosteroid formulations.
• Serves as a system suitability test component to ensure the performance of analytical instrumentation.
• Supports regulatory filings (e.g., ANDA, NDA) by providing necessary impurity data for drug substance characterization.

Basic Information

Product Name	Dexamethasone Sodium Phosphate Ep Impurity B
CAS No.	360-63-4
Molecular Formula	C22H28FNa2O8P
Molecular Weight	516.40 g/mol
Synonyms	9-Fluoro-11β,17-dihydroxy-16α-methyl-21-(phosphonooxy)pregna-1,4-diene-3,20-dione disodium salt; Dexamethasone 21-Phosphate Disodium Salt; Dexamethasone Sodium Phosphate Related Compound B; Dexamethasone Phosphate Impurity B; 16α-Methyl-9α-fluoro-1,4-pregnadiene-11β,17α,21-triol-3,20-dione 21-(dihydrogen phosphate) disodium salt; NSC 113455; Dexamethasone 21-(Disodium Phosphate)
EINECS	Contact for details

Quality Control

Every batch of Dexamethasone Sodium Phosphate Ep Impurity B is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC for purity and identity confirmation via IR and NMR, to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA), detailing batch-specific results, is provided with each shipment to support your regulatory and quality assurance requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at 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%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%
Heavy Metals	≤ 20 ppm
Specific Optical Rotation	Contact for details

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