Description

Desmethyl Iopamidol is a key pharmaceutical intermediate and reference standard, primarily used in the synthesis and quality control of iodinated contrast media. Its importance lies in its role as a precursor and impurity marker for Iopamidol, a widely used non-ionic, low-osmolar contrast agent for X-ray imaging procedures. This high-purity compound is essential for manufacturers and analytical laboratories in the pharmaceutical and diagnostic imaging sectors who require reliable materials for research, development, and stringent quality assurance protocols.

Application

• Pharmaceutical Intermediate: A critical building block in the synthesis of the contrast agent Iopamidol.
• Analytical Reference Standard: Used as a certified standard in HPLC, LC-MS, and other chromatographic methods for impurity profiling and assay determination of Iopamidol drug substance and finished products.
• Metabolite Studies: Employed in pharmacokinetic and metabolic pathway research related to iodinated contrast agents.
• Process Development & Validation: Serves as a key reagent in the development and validation of manufacturing processes for contrast media.
• Quality Control & Stability Testing: Essential for identifying and quantifying the desmethyl impurity in Iopamidol to ensure product safety and compliance with pharmacopeial standards (e.g., USP, EP).
• Regulatory Submissions: Used to generate data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).

Basic Information

Product Name	Desmethyl Iopamidol
CAS No.	77868-41-8
Molecular Formula	C16H21I3N3O8
Molecular Weight	758.07 g/mol
Synonyms	5-[(2-Hydroxy-1-oxopropyl)amino]-N,N'-bis(2,3-dihydroxypropyl)-2,4,6-triiodo-1,3-benzenedicarboxamide; 1-Desmethyl Iopamidol; Iopamidol Impurity C; Iopamidol EP Impurity C; Iopamidol Related Compound C; N-Desmethyl Iopamidol; SQ 32692 Desmethyl Derivative
EINECS	Contact for details

Quality Control

Our Desmethyl Iopamidol is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including identification (IR, HPLC), assay (HPLC), and rigorous control of related substances and residual solvents to ensure high purity and consistency. Certificates of Analysis (COA) are provided, detailing compliance with in-house specifications developed to meet the stringent requirements for pharmaceutical reference standards and intermediates.

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 product 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 powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0%

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