Description

Iopamidol Ep Impurity C is a specified impurity and reference standard used in the analytical profiling of the iodinated contrast agent Iopamidol. This compound is critical for ensuring the purity, safety, and efficacy of the final pharmaceutical product by serving as a benchmark in chromatographic analysis. It is primarily required by pharmaceutical manufacturers, quality control laboratories, and research institutions involved in the development and production of non-ionic contrast media.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Iopamidol Ep Impurity C in active pharmaceutical ingredients (APIs) and finished drug products.
• Quality Control & Assurance: Essential for HPLC, UPLC, and LC-MS methods to monitor impurity levels and ensure compliance with pharmacopeial limits (e.g., USP, EP, ICH guidelines).
• Method Development & Validation: Serves as a critical component in developing and validating analytical procedures for impurity profiling and stability studies.
• Regulatory Submissions: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary impurity characterization data for drug master files (DMFs) and new drug applications (NDAs).
• Research & Development: Utilized in studies to understand the degradation pathways and stability profile of Iopamidol.

Basic Information

Product Name	Iopamidol Ep Impurity C
CAS No.	87932-07-8
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 C; Iopamidol Related Compound C; Iopamidol EP Impurity C; 1,3-Bis(2,3-dihydroxypropyl)-5-[N-(2,3-dihydroxypropyl)acetamido]-2,4,6-triiodoisophthalamide; Iopamidol Isomer C
EINECS	Contact for details

Quality Control

Our Iopamidol Ep Impurity C is manufactured under strict quality systems to ensure high purity and batch-to-batch consistency, suitable for use as a reference standard. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) providing data on identity, purity (by HPLC), and impurity profile. We support compliance with ICH Q3B(R2) guidelines and relevant pharmacopeial standards (EP, USP).

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 hygroscopic (moisture-sensitive); ensure the container is sealed after each use to prevent absorption of moisture.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time corresponds to reference
Assay (HPLC)	≥ 95.0%
Related Substances (HPLC)	Any individual impurity: ≤ 1.0% 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.