Description

Iopamidol Ep Impurity G is a high-purity reference standard specifically identified as a process-related impurity of the iodinated contrast agent Iopamidol. This compound is critical for analytical method development, validation, and quality control in pharmaceutical manufacturing, ensuring the safety and efficacy of the final drug product. It is an essential material for research and quality assurance laboratories in the pharmaceutical and fine chemical industries focused on advanced imaging agents.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Iopamidol Ep Impurity G in active pharmaceutical ingredient (API) batches.
• Analytical Method Development: Crucial for developing and optimizing chromatographic methods, such as HPLC and UPLC, for impurity profiling.
• Quality Control & Assurance: Used in routine QC testing to monitor impurity levels against International Council for Harmonisation (ICH) guidelines to ensure batch-to-batch consistency.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity characterization data for drug master files (DMFs).
• Stability Studies: Employed to track the formation and growth of this specific impurity under various stress conditions during drug product shelf-life studies.
• Research & Development: Used in synthetic chemistry R&D to understand and mitigate the formation pathways of this impurity during Iopamidol synthesis.

Basic Information

Product Name	Iopamidol Ep Impurity G
CAS No.	1869069-72-6
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 Impurity G; Iopamidol Impurity G; Iopamidol EP Impurity G; Iopamidol Related Compound G; (5-{3-[(Acetyl)(methyl)amino]-2,4,6-triiodobenzamido}-N1,N3-bis(2,3-dihydroxypropyl)-2,4,6-triiodobenzene-1,3-dicarboxamide)
EINECS	Contact for details

Quality Control

Every batch of Iopamidol Ep Impurity G is manufactured and controlled under a strict quality management system. The material undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation (IR, MS), to ensure it meets the exacting standards required for use as a reference standard. A detailed Certificate of Analysis (COA) is provided with each shipment, containing batch-specific results for identity, assay, purity, and related substances.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing under inert atmosphere to ensure stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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