Description

Mesalazine Impurity 23 is a high-purity reference standard critical for pharmaceutical research and development. This compound is essential for the identification, quantification, and control of process-related impurities in mesalazine (5-aminosalicylic acid) drug substances and finished products. It is primarily used by analytical chemists and quality control laboratories in the pharmaceutical industry to ensure product safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material for analytical method development and validation in accordance with ICH Q2(R1) and Q3A/B guidelines.
• Impurity Profiling: Used for the identification and characterization of specific impurities during the stability testing and forced degradation studies of mesalazine APIs.
• Quality Control (QC) Testing: Employed as a system suitability standard in HPLC and UPLC methods to monitor batch-to-batch consistency of mesalazine drug products.
• Regulatory Compliance: Supports regulatory filings (e.g., ANDA, NDA) by providing definitive impurity data required by the FDA, EMA, and other global health authorities.
• Research & Development: Aids in synthetic route optimization by helping to identify and track the formation of this specific impurity during the manufacturing process.

Basic Information

Product Name	Mesalazine Impurity 23
CAS No.	5794-62-7
Molecular Formula	C7H7NO3
Molecular Weight	153.14 g/mol
Synonyms	5-Aminosalicylic Acid Impurity 23; 5-ASA Impurity 23; 3-Carboxy-4-hydroxyaniline; 4-Amino-2-hydroxybenzoic Acid; 2-Hydroxy-4-aminobenzoic Acid; 5-Amino-2-hydroxybenzoic Acid (common misassignment); Mesalamine Impurity 23
EINECS	Contact for details

Quality Control

Every batch of Mesalazine Impurity 23 is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC purity assay, identity confirmation (IR, NMR), and residual solvent analysis, to ensure compliance with industry standards for reference materials. 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 in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic nature, the container should be kept in a desiccated environment to prevent moisture absorption.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residue on Ignition	≤ 0.1%

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