Description

n-Acetyl Mesalazine-D3 CAS NO 93968-79-7 is a deuterium-labeled analog of n-acetyl mesalazine, a key metabolite of the anti-inflammatory drug mesalazine. This stable isotope-labeled compound is an essential reference standard and internal standard for precise quantitative analysis in pharmaceutical research and development. It is primarily used by analytical chemists and researchers in the pharmaceutical and biotechnology industries for method development, validation, and bioanalytical studies, particularly in pharmacokinetic and metabolic research related to inflammatory bowel disease treatments.

Application

• Internal Standard for LC-MS/MS: Serves as a critical, non-interfering internal standard for the accurate quantification of mesalazine and its metabolites in complex biological matrices like plasma, serum, and urine.
• Metabolite Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of the n-acetyl mesalazine metabolite in drug metabolism and pharmacokinetic (DMPK) studies.
• Bioanalytical Method Development: Essential for developing and validating robust, high-performance liquid chromatography (HPLC) and mass spectrometry methods to ensure regulatory compliance (FDA, EMA).
• Drug Impurity Profiling: Aids in the characterization and control of potential deuterated impurities or related substances in deuterated drug substances.
• Pharmacokinetic Modeling: Provides reliable data for building pharmacokinetic models to understand drug absorption, distribution, metabolism, and excretion (ADME).

Basic Information

Product Name	n-Acetyl Mesalazine-D3
CAS No.	93968-79-7
Molecular Formula	C9H6D3NO4
Molecular Weight	198.19 g/mol (approximate)
Synonyms	5-Acetamido-2-hydroxybenzoic-3,4,5-D3 Acid; Deuterated N-Acetyl Mesalazine; N-Acetyl-5-aminosalicylic Acid-D3; Mesalazine N-Acetyl-D3; 5-[(2H3)Acetylamino]-2-hydroxybenzoic Acid; N-Acetyl-5-ASA-D3; Acetylated Mesalazine-D3; Stable Isotope Labeled N-Acetyl Mesalamine
EINECS	Contact for details

Quality Control

Every batch of n-Acetyl Mesalazine-D3 is manufactured and analyzed under strict quality management systems. We provide comprehensive analytical data to support its use in regulated environments. The product is characterized by advanced spectroscopic techniques including NMR and Mass Spectrometry to confirm structure and isotopic enrichment. A detailed Certificate of Analysis (COA) is supplied with each lot, reporting key parameters such as chemical purity, isotopic purity (D-enrichment), and residual solvent content, ensuring traceability and compliance with research standards.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This compound is hygroscopic (moisture-sensitive); therefore, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity (D-enrichment)	≥ 98 atom % D
Chemical Purity (NMR)	Conforms
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH guidelines

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