Description

Iopromide Ep Impurity E is a specified impurity and reference standard used in the quality control of Iopromide, a widely used non-ionic, iodinated contrast agent. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure the purity, safety, and efficacy of the final drug product. It is primarily utilized in research and development, method validation, and routine batch testing within the pharmaceutical and fine chemical industries.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of Iopromide Ep Impurity E in active pharmaceutical ingredient (API) and finished drug product analysis.
• Method Development and Validation: Essential for developing and validating analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and related techniques, to monitor impurities in Iopromide.
• Quality Control and Assurance (QC/QA): Used in-house by API manufacturers and contract research organizations (CROs) to establish impurity profiles and ensure compliance with pharmacopeial standards (e.g., USP, EP).
• Stability Studies: Employed as a marker to track the formation of degradation products during forced degradation and long-term stability studies of Iopromide formulations.
• Regulatory Submissions: Provides critical data for regulatory filings (e.g., ANDA, NDA, CTA) to demonstrate thorough impurity characterization and control strategies to agencies like the FDA and EMA.
• Academic and Industrial Research: Supports research into the synthesis, degradation pathways, and metabolism of iodinated contrast media.

Basic Information

Product Name	Iopromide Ep Impurity E
CAS No.	154397-78-1
Molecular Formula	C18H24I3N3O8
Molecular Weight	791.02 g/mol
Synonyms	1-N,3-N-Bis(2,3-dihydroxypropyl)-2,4,6-triiodo-5-(methoxyacetylamino)-1,3-benzenedicarboxamide; 5-(Methoxyacetylamino)-1-N,3-N-bis(2,3-dihydroxypropyl)-2,4,6-triiodoisophthalamide; Iopromide Impurity E; Iopromide Related Compound E; Ultravist Impurity E; EP Impurity E of Iopromide
EINECS	Contact for details

Quality Control

Our Iopromide Ep Impurity E is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing to ensure identity, purity, and consistency, aligning with the requirements for pharmaceutical reference standards. Certificates of Analysis (COA) are provided, detailing results from tests such as HPLC purity, related substances, residual solvents, and identity confirmation (IR, MS). We support compliance with major pharmacopeias including the European Pharmacopoeia (EP) and United States Pharmacopeia (USP).

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent absorption of moisture. For long-term storage, consider desiccants or inert atmosphere.

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%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 2.0%
Assay (on dried basis)	98.0% - 102.0%

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