Description

Iopamidol Impurity K is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the widely used iodinated contrast agent, Iopamidol. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in drug development and quality control. The precise characterization of this impurity is essential for method validation and meeting stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the quality control and release testing of Iopamidol API and its formulated products.
• Analytical Method Development & Validation: Used to develop, optimize, and validate HPLC, UPLC, or LC-MS methods for impurity profiling and quantification.
• Stability Studies: Employed as a marker to monitor the formation of degradation products in Iopamidol under various stress conditions (e.g., heat, light, humidity).
• Regulatory Compliance & Documentation: Essential for preparing regulatory submissions (e.g., to FDA, EMA) by providing definitive identification and quantification data for specified impurities.
• Research & Development: Used in studies to understand the degradation pathways, pharmacokinetics, and toxicological profile of Iopamidol.
• Pharmacopeial Testing: Applied as a system suitability standard in tests per USP, EP, or other pharmacopeial monographs for Iopamidol.

Basic Information

Item	Details
Product Name	Iopamidol Impurity K
CAS No.	1788899-70-6
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; Iopamidol Related Compound K; Iopamidol EP Impurity K; Iopamidol USP Impurity K; Iopamidol Degradant; Iopamidol Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Iopamidol Impurity K is manufactured and controlled to meet the highest standards for chemical reference materials. Our quality system ensures identity, purity, and stability through comprehensive analytical techniques including HPLC, LC-MS, and NMR. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment, supporting its use in GMP/GLP environments and regulatory filings.

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 in a desiccated environment to maintain stability and purity.

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)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0%

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