Description

Rac-Iopamidol Ep Impurity J is a critical reference standard used in the analytical profiling and quality control of the iodinated contrast agent Iopamidol. This compound is essential for pharmaceutical manufacturers and analytical laboratories to identify, quantify, and control this specific stereoisomeric impurity during drug development and production. It is primarily utilized by professionals in the pharmaceutical industry, particularly those involved in research and development, quality assurance, and regulatory compliance for diagnostic imaging agents.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the calibration of analytical instruments and validation of testing methods.
• Method Development and Validation: Used in developing and validating HPLC, UPLC, and LC-MS methods for impurity profiling of Iopamidol.
• Quality Control (QC) Testing: Critical for routine batch analysis to ensure Iopamidol active pharmaceutical ingredient (API) and finished drug products meet stringent purity specifications.
• Regulatory Compliance and Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity characterization and control data.
• Stability Studies: Employed to monitor the formation of this impurity under various stress conditions to establish product shelf-life.
• Research and Development: Used in synthetic chemistry research to study the stereochemistry and degradation pathways of Iopamidol.

Basic Information

Product Name	Rac-Iopamidol Ep Impurity J
CAS No.	76349-97-8
Molecular Formula	C17H22I3N3O8
Molecular Weight	777.09 g/mol
Synonyms	5-[(1RS,2SR)-2-Hydroxy-1-(hydroxymethyl)propyl]carbamoyl-N,N'-bis(2,3-dihydroxypropyl)-2,4,6-triiodoisophthalamide; Iopamidol Racemic Epimer J; Iopamidol EP Impurity J; Iopamidol Related Compound J; (1RS,2SR)-1,3-Bis(2,3-dihydroxypropyl)-5-[(2-hydroxy-1-hydroxymethyl-propyl)carbamoyl]-2,4,6-triiodo-1,3-benzenedicarboxamide; rac-Iopamidol Epimer J
EINECS	Contact for details

Quality Control

Our Rac-Iopamidol Ep Impurity J is manufactured under strict quality systems to ensure high purity and batch-to-batch consistency, suitable for use as a reference standard. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing results from advanced chromatographic and spectroscopic analyses. We adhere to relevant pharmacopeial guidelines and support compliance with ICH Q3A/B, USP, and EP standards for impurities in new drug substances and products.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C. The product is light-sensitive and should be handled under appropriate conditions to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%
Assay	97.0% - 103.0% (on anhydrous basis)

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