Description

Iodixanol Related Compound D (50 Mg) (5-[Acetyl(2-Hydroxy-3-Methylpropyl)Amino]-N,N'-Bis(2,3-Dihydroxypropyl)2,4,6-Triiodo-1,3-Benze-Nedicarboxamide) is a critical reference standard and impurity used in the analytical profiling of the non-ionic, iso-osmolar X-ray contrast media agent, Iodixanol. This compound is essential for ensuring the safety, efficacy, and regulatory compliance of pharmaceutical formulations by enabling precise identification and quantification of related substances. It is primarily required by pharmaceutical manufacturers, quality control (QC) laboratories, and research institutions involved in the development and production of contrast media.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of Iodixanol Related Compound D in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Critical for developing, validating, and verifying High-Performance Liquid Chromatography (HPLC) and other chromatographic methods used in impurity profiling.
• Quality Control & Batch Release Testing: Used in routine QC testing to monitor impurity levels against International Council for Harmonisation (ICH) guidelines and pharmacopeial standards (e.g., USP, EP).
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) to establish product shelf life.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., to FDA, EMA) to demonstrate thorough impurity characterization and control strategies.
• Research on Contrast Media Chemistry: Serves as a tool for academic and industrial research into the metabolism, degradation pathways, and structure-activity relationships of iodinated contrast agents.

Basic Information

Product Name	Iodixanol Related Compound D (50 Mg)
CAS No.	89797-00-2
Molecular Formula	C35H44I3N3O9
Molecular Weight	959.45 g/mol
Synonyms	5-[Acetyl(2-Hydroxy-3-Methylpropyl)Amino]-N,N'-Bis(2,3-Dihydroxypropyl)-2,4,6-Triiodoisophthalamide; Iodixanol Impurity D; Iodixanol Related Substance D; Visipaque Related Compound D; 1-N,3-N-Bis(2,3-dihydroxypropyl)-5-[acetyl(2-hydroxy-3-methylpropyl)amino]-2,4,6-triiodobenzene-1,3-dicarboxamide; Iodixanol EP Impurity D; Iodixanol USP Related Compound D
EINECS	Contact for details

Quality Control

This reference standard is produced and controlled under a rigorous quality management system. Each batch is characterized using advanced analytical techniques including NMR, MS, and HPLC to confirm identity and purity. We provide comprehensive Certificates of Analysis (COA) with detailed chromatographic and spectroscopic data, ensuring traceability and compliance with the standards expected for pharmaceutical impurity analysis. Specifications are aligned with the requirements of major pharmacopeias.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or Certificate of Analysis. Keep the container in a dry, cool, and well-ventilated area. Handle with appropriate laboratory safety practices.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity ≤ 1.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0%

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