Description

Iopromide Ep Impurity F is a high-purity chemical reference standard critical for analytical and quality control processes in the pharmaceutical industry. This compound serves as a specified impurity for the non-ionic, iodinated contrast agent Iopromide, enabling precise monitoring and control during API synthesis and final drug product formulation. It is an essential material for pharmaceutical R&D laboratories, quality assurance departments, and manufacturers focused on producing Iopromide to meet stringent pharmacopeial standards such as USP and EP.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Iopromide Ep Impurity F in Iopromide active pharmaceutical ingredient (API) and finished drug products.
• Method Development and Validation: Essential for developing, optimizing, and validating analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and LC-MS, for impurity profiling.
• Quality Control and Batch Release: Critical for routine quality control testing to ensure Iopromide batches comply with pharmacopeial limits for specified impurities, supporting regulatory filings and GMP compliance.
• Stability Studies: Employed in forced degradation and long-term stability studies of Iopromide to track impurity formation and ensure product shelf-life.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., CMC sections for FDA, EMA) by providing definitive impurity characterization data.
• Research on Degradation Pathways: Used in academic and industrial research to study the synthesis, degradation mechanisms, and metabolism of Iopromide.

Basic Information

Product Name	Iopromide Ep Impurity F
CAS No.	154361-54-3
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)-N,N'-bis(2,3-dihydroxypropyl)-2,4,6-triiodoisophthalamide; Iopromide Impurity F; Iopromide Related Compound F; Ultravist Impurity F; EP Impurity F of Iopromide
EINECS	Contact for details

Quality Control

Every batch of Iopromide Ep Impurity F is manufactured and controlled under a strict quality management system. The product undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation (IR, NMR), to ensure it meets the high standards required for use as a pharmaceutical reference standard. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting batch-specific results and confirming compliance with relevant specifications.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. This material is hygroscopic (moisture-sensitive); ensure the container is sealed after each use to prevent absorption of atmospheric moisture.

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%
Water Content	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Specific Impurities (HPLC)	Individually ≤ 0.5%
Total Impurities (HPLC)	≤ 2.0%

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