Description

Iopamidol Impurity 12 is a high-purity chemical reference standard used in the analytical profiling and quality control of the iodinated contrast agent Iopamidol. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure product safety, efficacy, and regulatory compliance by accurately identifying and quantifying process-related impurities. It is an essential material for research and development, method validation, and stability studies within the pharmaceutical and diagnostic imaging sectors.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of Iopamidol Impurity 12 in active pharmaceutical ingredient (API) batches.
• Analytical Method Development & Validation: Critical for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurity profiles in Iopamidol synthesis.
• Quality Control & Assurance (QC/QA): Used in routine QC testing to ensure Iopamidol drug substance and drug products meet stringent pharmacopeial specifications (e.g., USP, EP).
• Stability Studies: Employed to track the formation of degradation products under various stress conditions (light, heat, humidity) to establish shelf-life and storage guidelines.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate control over the impurity profile of Iopamidol.
• Research on Contrast Agent Chemistry: Serves as a tool for academic and industrial research into the metabolism, degradation pathways, and structure-activity relationships of iodinated contrast media.

Basic Information

Product Name	Iopamidol Impurity 12
CAS No.	1798830-49-5
Molecular Formula	C17H22I3N3O8
Molecular Weight	777.09 g/mol
Synonyms	5-[3-Acetamido-2,4,6-triiodo-5-(N-methylacetamido)benzamido]-N,N'-bis(2,3-dihydroxypropyl)-2,4,6-triiodoisophthalamide Impurity 12; Iopamidol Related Compound 12; Iopamidol EP Impurity J; Iopamidol USP Impurity; 1-N,3-N-Bis(2,3-dihydroxypropyl)-5-{[3-(acetylamino)-2,4,6-triiodo-5-(methylamino)carbonyl]benzamido}-2,4,6-triiodobenzene-1,3-dicarboxamide isomer
EINECS	Contact for details

Quality Control

Every batch of Iopamidol Impurity 12 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assessment, and impurity profiling using advanced analytical techniques such as HPLC, NMR, and Mass Spectrometry to ensure it meets the exacting standards required for use as a reference material. A comprehensive Certificate of Analysis (COA) is provided with each lot, detailing batch-specific results. Our quality commitment aligns with cGMP principles to support our clients' regulatory needs.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept under dry conditions to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% 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.