Description

Ioxilan Related Compound A (100 Mg) (5-Amino-2,4,6-Triiodo-3 n-(2-Hydroxyethyl)Carba-Moyl Benzoic Acid) is a high-purity analytical reference standard, critical for quality control and research in the pharmaceutical industry. This compound serves as a specified impurity and degradation product of the iodinated contrast agent Ioxilan, making it essential for ensuring drug safety and efficacy. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and compliance testing. The product is supplied as 100 mg of precisely characterized material to support accurate quantitative analysis.

Application

• Pharmaceutical Impurity Profiling and Control: Used as a certified reference standard for the identification and quantification of Ioxilan Related Compound A in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development and Validation: Essential for developing, calibrating, and validating chromatographic methods (e.g., HPLC, UPLC) used in quality control laboratories.
• Stability Studies and Forced Degradation Testing: Employed to monitor the formation of this specific impurity under various stress conditions to establish product shelf-life.
• Regulatory Compliance and Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing a traceable standard for impurity limits as per ICH guidelines.
• Research and Development: Used in pharmacokinetic and metabolic studies to understand the behavior and pathways of Ioxilan and its related compounds.
• Quality Assurance/Quality Control (QA/QC): Serves as a system suitability standard and for routine batch release testing of contrast media.

Basic Information

Product Name	Ioxilan Related Compound A (100 Mg) (5-Amino-2,4,6-Triiodo-3 n-(2-Hydroxyethyl)Carba-Moyl Benzoic Acid)
CAS No.	22871-58-5
Molecular Formula	C11H11I3N2O4
Molecular Weight	647.93 g/mol
Synonyms	5-Amino-2,4,6-triiodo-N-(2-hydroxyethyl)isophthalamic acid; Ioxilan Impurity A; Ioxilan Related Substance A; 5-Amino-2,4,6-triiodo-3-[(2-hydroxyethyl)carbamoyl]benzoic acid; Benzoic acid, 5-amino-2,4,6-triiodo-3-[[(2-hydroxyethyl)amino]carbonyl]-; Ioxilan EP Impurity A; Ioxilan USP Related Compound A
EINECS	Contact for details

Quality Control

This analytical standard is manufactured and tested under strict quality systems. Each batch is characterized using advanced spectroscopic and chromatographic techniques to ensure high purity and accurate identity. Comprehensive Certificates of Analysis (COA) are provided, detailing results for assay, related substances, residual solvents, and other critical parameters. Our quality commitment aligns with the standards expected for pharmaceutical reference materials, supporting compliance with ICH, USP, and EP guidelines.

Storage

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

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unspecified impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH limits
Water Content (KF)	≤ 1.0%

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