Description

Mesalazine-13C6 Hydrochloride is a stable isotope-labeled analog of the active pharmaceutical ingredient mesalazine, where six carbon atoms are replaced with the carbon-13 isotope. This compound is an essential internal standard for the precise quantification of mesalazine in complex biological matrices using advanced analytical techniques like LC-MS/MS. It is primarily required by pharmaceutical R&D laboratories, clinical research organizations, and analytical testing facilities engaged in pharmacokinetic studies, bioequivalence testing, and method development for inflammatory bowel disease treatments.

Application

• Internal Standard for Bioanalysis: Serves as a critical reference standard in the quantitative analysis of mesalazine in plasma, serum, and urine via mass spectrometry.
• Pharmacokinetic and Metabolism Studies: Enables accurate tracking of drug absorption, distribution, metabolism, and excretion (ADME) in preclinical and clinical research.
• Method Development and Validation: Used to develop, optimize, and validate robust and sensitive analytical methods in compliance with GLP and FDA/EMA guidelines.
• Quality Control in Manufacturing: Supports impurity profiling and assay verification during the production of mesalazine-based drug products.
• Clinical Research: Facilitates reliable measurement of drug concentrations in patient samples for therapeutic drug monitoring and efficacy studies.

Basic Information

Product Name	Mesalazine-13C6 Hydrochloride
CAS No.	1261398-47-3
Molecular Formula	C713C6H8ClNO3
Molecular Weight	~199.6 (for unlabeled base: 153.14)
Synonyms	5-Amino-13C6-salicylic acid hydrochloride; Mesalamine-13C6 hydrochloride; 5-ASA-13C6 HCl; 5-Aminosalicylic acid-13C6 hydrochloride; 5-ASA-13C6 hydrochloride; Mesalazine-13C6 HCl; 5-Amino-2-hydroxybenzoic acid-13C6 hydrochloride
EINECS	Contact for details

Quality Control

Our Mesalazine-13C6 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 comprehensive analytical documentation, including NMR and mass spectral data to confirm structure and isotopic purity. Certificates of Analysis (COA) detailing assay, purity, and solvent content are available upon request.

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 material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability. 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 Enrichment	≥99 atom % 13C
Chemical Purity	≥95.0%
Water Content (KF)	≤2.0%
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.