Description

n-Propionyl Mesalazine-D3 is a deuterium-labeled derivative of mesalazine, a key pharmaceutical compound. This stable isotope-labeled analog is an essential internal standard for the precise quantification of mesalazine and its metabolites 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 service providers focused on developing and validating robust bioanalytical methods for pharmacokinetic studies and drug metabolism research.

Application

• Internal Standard for Bioanalysis: Serves as a critical reference compound in Liquid Chromatography-Mass Spectrometry (LC-MS/MS) for the accurate measurement of mesalazine in plasma, serum, and other biological samples.
• Drug Metabolism and Pharmacokinetics (DMPK) Studies: Enables precise tracking of drug absorption, distribution, metabolism, and excretion (ADME) profiles in preclinical and clinical research.
• Pharmaceutical Quality Control: Used in method development and validation to ensure the accuracy and reliability of impurity profiling and assay testing for mesalazine-based drug products.
• Metabolite Identification: Aids in the structural elucidation and quantification of mesalazine metabolites formed in vivo.
• Regulatory Submissions: Supports the generation of compliant data for regulatory filings with agencies like the FDA and EMA by providing traceable and consistent quantification standards.

Basic Information

Product Name	n-Propionyl Mesalazine-D3
CAS No.	1330265-97-8
Molecular Formula	C10H8D3NO4
Molecular Weight	Approx. 200.20 g/mol
Synonyms	5-Amino-2-hydroxybenzoic acid 3-(propionyl-d3); Deuterated n-Propionyl Mesalazine; Mesalazine-d3 Propionate; 5-ASA-d3 Propionyl Ester; 5-Aminosalicylic Acid-d3 Propionate; Deuterium Labeled Mesalazine Propionate; Internal Standard for Mesalazine LC-MS/MS
EINECS	Contact for details

Quality Control

Our n-Propionyl Mesalazine-D3 is manufactured under strict quality control protocols to ensure high chemical purity and isotopic enrichment, critical for its role as an analytical standard. Each batch is characterized using NMR, HPLC, and mass spectrometry to confirm identity, chemical purity, and deuterium incorporation. A comprehensive Certificate of Analysis (COA) is provided, detailing batch-specific results for all critical parameters.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. Keep the container in a dry, well-ventilated place. For long-term storage, consider storing desiccated at -20°C.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity (D3)	≥ 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.