Description

Diatrizoic Acid Related Compound A (5-Acetamido-3-Amino-2,4,6-Triiodobenzoic Acid) is a key analytical reference standard used for quality control in pharmaceutical manufacturing. This compound is critical for ensuring the purity and safety of contrast media formulations, particularly those containing diatrizoic acid. It is primarily required by pharmaceutical R&D laboratories, quality assurance departments, and regulatory bodies for method validation and impurity profiling.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in diatrizoic acid-based X-ray contrast agents.
• Analytical Method Development & Validation: Essential for developing and validating High-Performance Liquid Chromatography (HPLC) and other chromatographic methods in QC labs.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., FDA, EMA) by providing definitive impurity characterization for drug master files and pharmacopeial monographs.
• Stability Studies: Used as a marker compound in forced degradation and long-term stability studies of contrast media products.
• Research on Contrast Media Chemistry: Serves as a building block or intermediate in research focused on synthesizing or modifying iodinated contrast agents.

Basic Information

Product Name	Diatrizoic Acid Related Compound A (5-Acetamido-3-Amino-2,4,6-Triiodobenzoic Acid)
CAS No.	1713-07-1
Molecular Formula	C9H7I3N2O3
Molecular Weight	571.87 g/mol
Synonyms	5-Acetamido-3-amino-2,4,6-triiodobenzoic Acid; 3-Acetamido-5-amino-2,4,6-triiodobenzoic Acid; Benzoic acid, 5-(acetylamino)-3-amino-2,4,6-triiodo-; Diatrizoate Impurity A; Diatrizoic Acid Impurity A; NSC 401564; Amidorizoate Impurity A
EINECS	Contact for details

Quality Control

This high-purity reference material is produced under strict quality control conditions suitable for analytical and pharmaceutical applications. Each batch is characterized using advanced spectroscopic and chromatographic techniques to confirm identity and purity. Certificates of Analysis (COA) are provided, detailing batch-specific results for assay, related substances, and residual solvents, ensuring traceability and compliance with ICH guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. Due to its light-sensitive and easily oxidized nature, prolonged exposure to light and air should be avoided. For long-term storage, consider keeping the material under an 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
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Heavy Metals	≤ 20 ppm
Loss on Drying	≤ 1.0%

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