Description

Iopamidol Ep Impurity F is a high-purity chemical reference standard used in the analytical profiling and quality control of the pharmaceutical agent Iopamidol. This compound is critical for ensuring the safety and efficacy of the final drug product by enabling the accurate identification and quantification of process-related impurities. It is an essential material for pharmaceutical R&D laboratories, quality assurance departments, and manufacturers specializing in non-ionic iodinated contrast media.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for analytical method development and validation.
• Quality Control & Assurance: Used in HPLC, LC-MS, and other chromatographic systems to monitor and control the levels of Iopamidol Ep Impurity F in active pharmaceutical ingredients (APIs) and finished drug products.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing impurity identification data required for drug master files (DMFs) and Common Technical Documents (CTD).
• Stability Studies: Employed as a marker in forced degradation and long-term stability studies of Iopamidol to understand impurity formation pathways.
• Process Chemistry Research: Aids in the optimization of synthesis and purification processes to minimize the formation of this specific impurity.
• Academic & Contract Research: Serves as a research tool in universities and CROs for studies related to contrast media chemistry and impurity characterization.

Basic Information

Product Name	Iopamidol Ep Impurity F
CAS No.	1869069-71-5
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-triiodo-1,3-benzenedicarboxamide; Iopamidol Impurity F; Iopamidol EP Impurity F; Iopamidol Related Compound F; 1,3-Bis(2,3-dihydroxypropyl)-5-[(2,3-dihydroxypropyl)acetamido]-2,4,6-triiodobenzene-1,3-dicarboxamide; Iopamidol Isomer Impurity; Iopamidol Process Impurity.
EINECS	Contact for details

Quality Control

Every batch of Iopamidol Ep Impurity F is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques such as HPLC, LC-MS, and NMR to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. We support regulatory requirements for pharmaceutical impurities and reference standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The material is light-sensitive and should be handled under appropriate conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual 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.