Description

Mesalazine-13C6 is a stable isotope-labeled analog of the anti-inflammatory drug mesalazine, where six carbon atoms are replaced with the carbon-13 isotope. This high-purity compound is essential for use as an internal standard in quantitative mass spectrometry, ensuring unparalleled accuracy and reliability in analytical measurements. It is critically needed by pharmaceutical research laboratories, contract research organizations (CROs), and regulatory bodies for applications in drug metabolism and pharmacokinetics (DMPK) studies, bioanalytical method development, and clinical trial sample analysis.

Application

• Internal Standard for LC-MS/MS: Primary application as a quantitative reference standard in liquid chromatography-tandem mass spectrometry for the analysis of mesalazine and its metabolites in biological matrices.
• Pharmacokinetic/Pharmacodynamic (PK/PD) Studies: Enables precise measurement of drug concentration-time profiles in plasma, serum, urine, and tissue homogenates.
• Bioanalytical Method Development and Validation: Used to establish robust, sensitive, and specific analytical methods compliant with FDA, EMA, and ICH guidelines.
• Metabolite Identification and Profiling: Aids in the structural elucidation and quantification of mesalazine metabolites during drug development.
• Clinical Trial Support: Critical for the accurate bioanalysis of samples from clinical trials to assess drug safety and efficacy.
• Quality Control in Pharmaceutical Manufacturing: Can be utilized in advanced QC protocols to monitor the active pharmaceutical ingredient (API) or finished product.

Basic Information

Item	Detail
Product Name	Mesalazine-13C6
CAS No.	1189709-96-3
Molecular Formula	C713C6H7NO3
Molecular Weight	~177.14 g/mol (for 13C6 labeled form)
Synonyms	5-Amino-2-hydroxybenzoic acid-13C6; Mesalamine-13C6; 5-ASA-13C6; 5-Aminosalicylic acid-13C6; 13C6-Mesalazine; 13C6-Mesalamine; Isotopically labeled mesalazine; Carbon-13 labeled 5-ASA
EINECS	Contact for details

Quality Control

Every batch of Mesalazine-13C6 is manufactured and tested under strict quality systems. We guarantee high chemical purity and isotopic enrichment, typically ≥98% chemical purity and ≥99% atom 13C, verified by advanced analytical techniques including HPLC, NMR, and mass spectrometry. A comprehensive Certificate of Analysis (COA) detailing purity, isotopic enrichment, residual solvents, and other critical parameters is provided with each shipment to support your regulatory submissions and ensure traceability.

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); the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms to reference standard
Identification (MS)	Conforms to expected mass spectrum
Purity (HPLC)	≥ 98.0%
Isotopic Purity (Atom % 13C)	≥ 99.0%
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.