Description

Amidotrizoic Acid Impurity 2 (Amidotrizoic Acid EP Impurity B) is a high-purity reference standard critical for pharmaceutical quality control and analytical method development. This compound serves as a specified impurity for the validation and monitoring of Amidotrizoic Acid, a key iodinated contrast agent used in diagnostic imaging. It is an essential material for research and development laboratories, quality assurance units, and regulatory affairs departments within the pharmaceutical and fine chemical industries. Ensuring the identity, purity, and consistency of this impurity is fundamental to meeting stringent pharmacopeial standards for drug substance and product safety.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Amidotrizoic Acid active pharmaceutical ingredient (API) and its formulations.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods in compliance with ICH Q2(R1) and pharmacopeial guidelines.
• Pharmacopeial Compliance: Used to demonstrate compliance with European Pharmacopoeia (EP), United States Pharmacopeia (USP), and other international monographs for Amidotrizoic Acid.
• Stability Studies: Employed as a marker in forced degradation and long-term stability studies to track impurity profiles over time.
• Quality Control (QC) Testing: Serves as a system suitability and calibration standard in routine QC testing of API batches to ensure impurity levels are within specified limits.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., CMC sections of IND, NDA, ANDA, MAAs) to establish impurity acceptance criteria.

Basic Information

Item	Detail
Product Name	Amidotrizoic Acid Impurity 2 (Amidotrizoic Acid EP Impurity B)
CAS No.	162193-52-4
Molecular Formula	C11H9I3N2O4
Molecular Weight	613.91 g/mol
Synonyms	3,5-Bis(acetylamino)-2,4,6-triiodobenzoic Acid Impurity B; Diatrizoic Acid Impurity B; 3,5-Diacetamido-2,4,6-triiodobenzoic Acid Related Compound B; Amidotrizoate Impurity B; Ametrizoic Acid Impurity 2; CAS 162193-52-4; EP Impurity B of Amidotrizoic Acid
EINECS	Contact for details

Quality Control

Every batch of Amidotrizoic Acid Impurity 2 is manufactured and controlled under a strict quality management system. The product undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (IR, MS), to ensure it meets the high standards required for use as a pharmaceutical reference standard. A comprehensive Certificate of Analysis (COA) is provided with each lot, detailing batch-specific results. Our quality commitment aligns with the requirements for chemicals used in pharmaceutical development under cGMP principles.

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 light-sensitive (store away from light).

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0% w/w
Heavy Metals	≤ 20 ppm

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