Description

Iopamidol Ep Impurity D CAS NO 87932-11-4 is a specified impurity and reference standard used in the analytical profiling of the pharmaceutical active ingredient Iopamidol. This compound is critical for ensuring the purity, safety, and efficacy of Iopamidol-based contrast media through rigorous quality control protocols. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the development, production, and quality assurance of non-ionic, iodinated X-ray contrast agents.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Iopamidol Ep Impurity D in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating high-performance liquid chromatography (HPLC) and other chromatographic methods in quality control laboratories.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., with FDA, EMA) by providing impurity profiles and establishing specification limits as per ICH Q3A/B guidelines.
• Stability Studies: Employed to monitor impurity levels in Iopamidol formulations under various stress conditions (e.g., heat, light, humidity) to determine shelf life.
• Process Chemistry & Optimization: Used by R&D and process development scientists to identify and control the formation of this impurity during the synthesis and purification of Iopamidol.
• Quality Control Testing: Routinely used in in-process control (IPC) and release testing of Iopamidol batches to ensure compliance with pharmacopeial standards (e.g., USP, EP).

Basic Information

Item	Details
Product Name	Iopamidol Ep Impurity D
CAS No.	87932-11-4
Molecular Formula	C17H22I3N3O8
Molecular Weight	777.09 g/mol
Synonyms	5-[3-(Acetylmethylamino)-2,4,6-triiodobenzamido]-N,N'-bis(2,3-dihydroxypropyl)-2,4,6-triiodoisophthalamide; Iopamidol Impurity D; Iopamidol Related Compound D; Iopamidol EP Impurity D; Iopamidol USP Impurity D; 1-N,3-N-Bis(2,3-dihydroxypropyl)-5-[3-(N-methylacetamido)-2,4,6-triiodobenzamido]-2,4,6-triiodoisophthalamide; Iopamidol Isomer D
EINECS	Contact for details

Quality Control

Our Iopamidol Ep Impurity D is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation (IR, NMR), to ensure it meets the stringent requirements for use as a pharmaceutical reference standard. Certificates of Analysis (COA) are provided, detailing batch-specific results and confirming compliance with relevant pharmacopeial monographs.

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 light-sensitive; therefore, containers must be kept tightly sealed and desiccated 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
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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