Description

Mesalamine-D3 is a deuterium-labeled analog of the active pharmaceutical ingredient mesalamine, a key compound used in the development and validation of analytical methods. This stable isotope-labeled internal standard is essential for ensuring the accuracy and reliability of pharmacokinetic and metabolic studies. It is primarily utilized by pharmaceutical R&D laboratories, contract research organizations (CROs), and analytical testing facilities specializing in bioanalytical method development for inflammatory bowel disease treatments.

Application

• Bioanalytical Method Development: Serves as a critical internal standard in Liquid Chromatography-Mass Spectrometry (LC-MS/MS) for the precise quantification of mesalamine in biological matrices.
• Pharmacokinetic (PK) and Pharmacodynamic (PD) Studies: Enables accurate tracking of drug absorption, distribution, metabolism, and excretion in clinical and pre-clinical research.
• Metabolite Identification and Profiling: Aids in distinguishing drug-derived metabolites from endogenous compounds in complex biological samples.
• Drug Impurity and Degradation Product Analysis: Used as a reference standard in stability-indicating methods to monitor product quality.
• Regulatory Submission Support: Provides essential data for FDA, EMA, and other global regulatory agency filings requiring validated bioanalytical methods.
• Clinical Trial Research: Supports the analytical needs of Phase I-IV clinical trials for mesalamine-based therapeutics.

Basic Information

Product Name	Mesalamine-D3
CAS No.	1309283-32-6
Molecular Formula	C7H4D3NO3
Molecular Weight	156.15 g/mol
Synonyms	5-Aminosalicylic Acid-D3; 5-ASA-D3; Mesalazine-D3; 5-Amino-2-hydroxybenzoic Acid-D3; Deuterated Mesalamine; [2H3]-Mesalamine; Mesalamine (phenyl-D3); 5-ASA (phenyl-D3)
EINECS	Contact for details

Quality Control

Our Mesalamine-D3 is manufactured under strict quality control protocols to ensure the highest isotopic purity and chemical integrity. Each batch is characterized by advanced spectroscopic techniques including NMR and Mass Spectrometry. We provide comprehensive Certificates of Analysis (COA) detailing isotopic enrichment (typically ≥98 atom % D), chemical purity (by HPLC), and other critical specifications. Our quality system supports compliance with cGMP and ICH guidelines for reference standards.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at 2-8°C. This product is hygroscopic (moisture-sensitive) and should be handled in a controlled environment to minimize exposure to atmospheric humidity. For long-term storage, consider storing under an inert atmosphere.

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	≥98 atom % D
Chemical Purity	≥95%
Water Content (KF)	≤1.0%
Residual Solvents (GC)	Complies with ICH limits

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