Description

Iopamidol Ep Impurity E is a specified impurity used in the quality control and analytical profiling of the iodinated contrast agent Iopamidol. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure the purity, safety, and efficacy of the final drug product. It is primarily utilized by professionals in pharmaceutical R&D, quality assurance, and regulatory affairs for method development, validation, and compliance testing.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of Iopamidol-related impurities in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating High-Performance Liquid Chromatography (HPLC) and other chromatographic methods to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to ensure Iopamidol meets stringent pharmacopeial specifications (e.g., USP, EP, ICH guidelines) for impurity limits.
• Stability Studies: Employed to track the formation of degradation products under various stress conditions, supporting shelf-life determination and regulatory filings.
• Regulatory Compliance & Documentation: Provides necessary data for regulatory submissions (e.g., ANDA, NDA) to agencies like the FDA and EMA, demonstrating thorough impurity characterization.
• Research on Degradation Pathways: Aids in studying the chemical stability and degradation mechanisms of Iopamidol, informing better formulation strategies.

Basic Information

Product Name	Iopamidol Ep Impurity E
CAS No.	60166-92-9
Molecular Formula	C17H22I3N3O8
Molecular Weight	777.09 g/mol
Synonyms	5-[Acetyl(2,3-dihydroxypropyl)amino]-N,N'-bis(2,3-dihydroxypropyl)-2,4,6-triiodo-1,3-benzenedicarboxamide; 1,3-Bis[(2,3-dihydroxypropyl)carbamoyl]-5-[N-(2,3-dihydroxypropyl)acetamido]-2,4,6-triiodobenzene; Iopamidol Impurity E; Iopamidol Related Compound E; Iopamidol EP Impurity E; Iopamidol USP Impurity E
EINECS	Contact for details

Quality Control

Every batch of Iopamidol Ep Impurity E is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing to ensure compliance with relevant pharmacopeial standards (EP, USP) and ICH Q3A/B guidelines. 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 in a cool, dry place at a controlled room temperature (typically 15-25°C). This material is hygroscopic (moisture-sensitive); ensure the container is sealed tightly after each use to prevent degradation from atmospheric moisture.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unspecified impurity ≤ 1.0%
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.