Description

Iomeprol Impurity 4 is a specified impurity and degradation product of the iodinated X-ray contrast agent Iomeprol. This compound is critical for pharmaceutical research and development, serving as a certified reference standard for analytical method development, validation, and quality control. It is essential for manufacturers, analytical laboratories, and regulatory bodies involved in ensuring the purity, safety, and efficacy of Iomeprol-based contrast media.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Iomeprol Impurity 4 in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development: Crucial for developing and optimizing chromatographic methods, such as HPLC and UPLC, for impurity profiling of Iomeprol.
• Quality Control & Assurance (QC/QA): Used in routine batch testing to monitor impurity levels and ensure compliance with pharmacopeial specifications (e.g., USP, EP, ICH guidelines).
• 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 necessary data and characterization for regulatory filings (e.g., FDA, EMA) to demonstrate thorough impurity control strategies.
• Research & Development: Supports synthetic chemistry research for process optimization and impurity synthesis studies related to iodinated contrast agents.

Basic Information

Product Name	Iomeprol Impurity 4
CAS No.	2068038-50-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	5-[Acetyl(2,3-dihydroxypropyl)amino]-N,N'-bis(2,3-dihydroxypropyl)-2,4,6-triiodo-1,3-benzenedicarboxamide; Iomeprol Related Compound; Iomeprol Degradation Product; Iomeprol Process Impurity; Iomeprol Specified Impurity 4
EINECS	Contact for details

Quality Control

Our Iomeprol Impurity 4 is manufactured and handled under strict quality management systems. Each batch undergoes comprehensive analytical characterization using advanced techniques such as HPLC, MS, and NMR to confirm identity and purity. We provide a comprehensive Certificate of Analysis (COA) with each shipment, detailing batch-specific results. The material is suitable for use as a reference standard in compliance with ICH Q3A, Q3B, and relevant pharmacopeial (USP/EP) guidelines for impurities.

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 COA. The product is light-sensitive and should be handled under appropriate conditions to prevent degradation. Keep the container in a dry, cool, and well-ventilated area.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Mass spectrum conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity ≤ 0.5% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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