Description

Iopromide Ep Impurity C is a specified impurity and degradation product of the iodinated contrast agent Iopromide. This compound is critical for analytical reference and quality control in pharmaceutical development and manufacturing. It is primarily used by researchers and quality assurance professionals in the pharmaceutical industry to ensure the purity, safety, and efficacy of Iopromide-based contrast media.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of impurities in Iopromide active pharmaceutical ingredient (API) and finished drug products.
• Method Development and Validation: Essential for developing and validating analytical methods, such as HPLC and LC-MS, to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Used in routine batch testing to ensure Iopromide meets stringent pharmacopeial specifications (e.g., USP, EP, ICH guidelines) for impurity limits.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) to establish product shelf life.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough understanding and control of the drug substance impurity profile.
• Research and Development: Utilized in R&D laboratories to study the degradation pathways and chemical behavior of Iopromide.

Basic Information

Product Name	Iopromide Ep Impurity C
CAS No.	154361-52-1
Molecular Formula	C18H24I3N3O8
Molecular Weight	791.02 g/mol
Synonyms	1-N,3-N-Bis(2,3-dihydroxypropyl)-2,4,6-triiodo-5-(methoxyacetamido)isophthalamide; 5-(Methoxyacetylamino)-1-N,3-N-bis(2,3-dihydroxypropyl)-2,4,6-triiodoisophthalamide; Iopromide Impurity C; Iopromide Related Compound C; Ultravist Impurity C
EINECS	Contact for details

Quality Control

Every batch of Iopromide Ep Impurity C is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced chromatographic techniques (HPLC, LC-MS) to ensure compliance with pharmacopeial standards and customer specifications. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

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

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual 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.