Description

Aminomethylbenzoic Acid Impurity 3 is a high-purity chemical reference standard, specifically identified as an impurity of the pharmaceutical intermediate aminomethylbenzoic acid. This compound is critical for analytical method development, validation, and quality control in pharmaceutical manufacturing, ensuring the safety and efficacy of final drug products. It is primarily used by research institutions, quality control laboratories, and manufacturers in the pharmaceutical and fine chemical industries who require precise impurity profiling for regulatory compliance.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Aminomethylbenzoic Acid and related Active Pharmaceutical Ingredients (APIs).
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, and GC methods in quality control laboratories.
• Pharmacopeial Compliance: Supports testing to meet stringent pharmacopeial standards (e.g., USP, EP, ICH guidelines Q3A/B) for impurity limits.
• Stability Studies: Employed in forced degradation and long-term stability studies to monitor impurity formation in drug substances and products.
• Process Chemistry Research: Used by R&D chemists to study and optimize synthesis pathways to minimize the formation of this specific impurity.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).

Basic Information

Product Name	Aminomethylbenzoic Acid Impurity 3
CAS No.	179076-85-8
Molecular Formula	C9H9NO2
Molecular Weight	163.17 g/mol
Synonyms	4-(Aminomethyl)benzoic Acid Impurity 3; 4-Carboxybenzylamine Impurity 3; PAMBA Impurity 3; Tranexamic Acid Related Compound (structural analog); 4-(Aminomethyl)benzoic Acid Related Substance 3; 1-Carboxy-4-(aminomethyl)benzene Impurity; (4-Carboxyphenyl)methanamine Impurity
EINECS	Contact for details

Quality Control

Every batch of Aminomethylbenzoic Acid Impurity 3 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced analytical techniques such as HPLC, GC-MS, and NMR to ensure compliance with industry standards. Certificates of Analysis (COA) containing detailed batch-specific results are available upon request to support your regulatory and quality assurance needs.

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 moisture.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0% w/w

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