Description

Iopamidol Ep Impurity J is a critical reference standard used in the pharmaceutical quality control process. This compound is essential for the accurate identification, quantification, and monitoring of process-related impurities in the production of the iodinated contrast agent Iopamidol. It is primarily required by analytical laboratories, research institutions, and pharmaceutical manufacturers engaged in method development, stability studies, and regulatory compliance for injectable formulations.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for HPLC, LC-MS, and other chromatographic methods.
• Analytical Method Development & Validation: Used to establish and validate impurity profiling methods for Iopamidol API and finished drug products.
• Quality Control & Batch Release Testing: Critical for ensuring drug substance and drug product purity meets pharmacopeial specifications (e.g., USP, EP).
• Stability Studies: Employed to track the formation and levels of this specific impurity over the shelf-life of Iopamidol-based contrast media.
• Regulatory Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing definitive impurity characterization data.
• Research on Degradation Pathways: Aids in understanding the chemical stability and degradation mechanisms of Iopamidol.

Basic Information

Product Name	Iopamidol Ep Impurity J
CAS No.	77868-44-1
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-triiodoisophthalamide; Iopamidol Impurity J; Iopamidol EP Impurity J; Iopamidol Related Compound J; 1-N,3-N-Bis(2,3-dihydroxypropyl)-5-[N-(2,3-dihydroxypropyl)acetamido]-2,4,6-triiodoisophthalamide; Iopamidol Isomer J
EINECS	Contact for details

Quality Control

Every batch of Iopamidol Ep Impurity J is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity profiling using advanced techniques like HPLC and LC-MS to ensure they meet the stringent requirements for pharmaceutical reference standards. 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 (15-25°C) in a dry environment. For long-term storage, consider storing at 2-8°C. Keep the container sealed to protect from moisture.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% 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.