Description

Mesalazine-D3 Hydrochloride is a deuterium-labeled isotopologue of the active pharmaceutical ingredient mesalazine, a key compound in the treatment of inflammatory bowel diseases. This stable isotope-labeled analog is an essential reference standard and internal standard for the precise quantification and pharmacokinetic studies of mesalazine in biological matrices using advanced analytical techniques like LC-MS/MS. It is primarily required by pharmaceutical R&D laboratories, contract research organizations (CROs), and analytical testing facilities engaged in drug metabolism and bioanalytical method development to ensure accurate and reliable data.

Application

• Bioanalytical Reference Standard: Serves as a critical internal standard for the accurate quantification of mesalazine in plasma, serum, and other biological samples via mass spectrometry.
• Pharmacokinetic and Metabolism Studies: Enables precise tracking of drug absorption, distribution, metabolism, and excretion (ADME) in preclinical and clinical research.
• Drug Impurity Profiling: Used as a marker in the development and validation of analytical methods to identify and quantify related substances and degradation products.
• Stable Isotope Labeling Studies: Facilitates mechanistic studies in drug metabolism due to its deuterium labeling, which provides a distinct mass signature.
• Quality Control in Pharmaceutical Manufacturing: Employed in in-process testing and final product release assays to ensure the potency and purity of mesalazine-based drug products.
• Regulatory Submissions: Supports the development of validated bioanalytical methods required for regulatory filings with agencies like the FDA and EMA.

Basic Information

Product Name	Mesalazine-D3 Hydrochloride
CAS No.	1346601-18-0
Molecular Formula	C7H4D3NO3•HCl
Molecular Weight	218.62 g/mol
Synonyms	5-Amino-2-hydroxybenzoic acid-2,4,6-D3 hydrochloride; Mesalamine-D3 hydrochloride; 5-ASA-D3 hydrochloride; 5-Aminosalicylic acid-D3 hydrochloride; Deuterated mesalazine HCl; [2H3]-Mesalazine hydrochloride; MLS000755566
EINECS	Contact for details

Quality Control

Our Mesalazine-D3 Hydrochloride is manufactured under strict quality control protocols to ensure high chemical purity and isotopic enrichment suitable for sensitive analytical applications. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing parameters such as assay (by HPLC), isotopic purity, chemical purity, and identification. We adhere to relevant industry standards for reference materials to support your critical research and development needs.

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 product is hygroscopic (moisture-sensitive) and must be kept under inert conditions or in a desiccator to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.0%
Isotopic Purity	≥ 98 atom % D
Chemical Purity	≥ 95.0%
Water Content (KF)	≤ 2.0%
Residue on Ignition	≤ 0.1%

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