Description

Iohexol Ep Impurity I is a critical reference standard and impurity used in the analytical profiling of Iohexol, a widely used non-ionic, low-osmolar contrast medium. This compound is essential for pharmaceutical quality control, enabling the precise identification and quantification of related substances to ensure drug safety and efficacy. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the development, production, and quality assurance of Iohexol-based contrast agents.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the calibration of analytical instruments and validation of testing methods.
• Impurity Profiling & Control: Used in the identification and quantification of the epoxide impurity (Iohexol Ep Impurity I) during the stability testing and release of Iohexol Active Pharmaceutical Ingredient (API) and finished drug products.
• Method Development & Validation: Critical for developing and validating High-Performance Liquid Chromatography (HPLC) and other chromatographic methods in compliance with ICH guidelines.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing necessary impurity data for drug master files and quality dossiers.
• Research & Development: Utilized in R&D studies to understand the degradation pathways and stability profile of Iohexol.
• Quality Assurance/Quality Control (QA/QC): An integral component in the routine batch analysis and quality control protocols of contrast media manufacturing.

Basic Information

Product Name	Iohexol Ep Impurity I
CAS No.	196309-19-0
Molecular Formula	C19H26I3N3O9
Molecular Weight	821.04 g/mol
Synonyms	Iohexol Epoxide Impurity; Iohexol Impurity I (EP); Iohexol Related Compound I; 5-[Acetyl(2,3-dihydroxypropyl)amino]-N,N'-bis(2,3-dihydroxypropyl)-2,4,6-triiodo-1,3-benzenedicarboxamide Epoxide; 1-N,3-N-Bis(2,3-dihydroxypropyl)-5-[N-(2,3-dihydroxypropyl)acetamido]-2,4,6-triiodoisophthalamide Epoxide; Iohexol EP Impurity; Iohexol Impurity E
EINECS	Contact for details

Quality Control

Every batch of Iohexol Ep Impurity I is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced analytical techniques such as HPLC, NMR, and Mass Spectrometry to ensure compliance with pharmacopeial standards (e.g., EP, USP). A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C, in a dry environment. This material is hygroscopic (moisture-sensitive) and should be handled under anhydrous conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
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.