Description

Iopromide Ep Impurity G is a high-purity chemical reference standard, specifically identified as a known impurity of the iodinated contrast agent Iopromide. This compound is critical for analytical method development, validation, and quality control in pharmaceutical manufacturing. It is primarily used by research institutions, analytical laboratories, and pharmaceutical companies involved in the synthesis, purification, and regulatory compliance of contrast media.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the qualitative and quantitative analysis of Iopromide.
• Analytical Method Development: Used in HPLC, UPLC, and LC-MS methods to establish impurity profiles and ensure method specificity.
• Quality Control & Assurance: Essential for batch release testing of Iopromide active pharmaceutical ingredient (API) to monitor and control impurity levels.
• Regulatory Compliance & Filing: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing identified impurity markers.
• Stability Studies: Employed to track the formation of degradation products in Iopromide formulations over time.
• Research & Development: Utilized in studies to understand the degradation pathways and metabolism of iodinated contrast agents.

Basic Information

Product Name	Iopromide Ep Impurity G
CAS No.	154361-53-2
Molecular Formula	C18H24I3N3O8
Molecular Weight	791.02 g/mol
Synonyms	5-[Acetyl(2,3-dihydroxypropyl)amino]-N,N'-bis(2,3-dihydroxypropyl)-2,4,6-triiodoisophthalamide; Iopromide Impurity G; Iopromide Related Compound G; 1-N,3-N-Bis(2,3-dihydroxypropyl)-5-[N-(2,3-dihydroxypropyl)acetamido]-2,4,6-triiodoisophthalamide; Ultravist Impurity G; EP Impurity G of Iopromide
EINECS	Contact for details

Quality Control

Every batch of Iopromide Ep Impurity G is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC for purity and identity confirmation (IR, MS), to ensure compliance with pharmacopeial standards (EP/ USP). 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. For long-term storage, consider storing under inert atmosphere to prevent potential degradation.

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 guidelines
Water Content (KF)	≤ 1.0%

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