Description

n-Acetyl Mesalamine-D3 is a deuterated derivative of the active pharmaceutical ingredient mesalamine, specifically designed for use as an internal standard in analytical chemistry. This high-purity compound is essential for ensuring the accuracy and reliability of quantitative analyses, particularly in pharmacokinetic and metabolic studies. It is primarily required by pharmaceutical R&D laboratories, contract research organizations (CROs), and analytical testing facilities engaged in the development and quality control of gastrointestinal therapeutics.

Application

• Internal Standard for LC-MS/MS: Critical for the precise quantification of mesalamine and its metabolites in biological matrices like plasma, serum, and urine.
• Pharmaceutical R&D: Used in method development and validation during drug discovery and development stages for ulcerative colitis and Crohn's disease treatments.
• Bioanalytical Studies: Enables accurate pharmacokinetic (PK) and bioavailability studies by correcting for instrument variability and sample preparation losses.
• Metabolite Tracing: Serves as a stable isotope-labeled tracer in metabolic pathway research and drug metabolism studies.
• Quality Control & Assurance: Employed in GMP environments to ensure the accuracy of assay methods for active pharmaceutical ingredients (APIs) and finished drug products.
• Clinical Research: Supports analytical work in clinical trials to monitor drug levels and adherence in patient samples.

Basic Information

Product Name	n-Acetyl Mesalamine-D3
CAS No.	1309935-89-4
Molecular Formula	C9H6D3NO4
Molecular Weight	198.19 g/mol (approx.)
Synonyms	5-Acetamido-2-hydroxybenzoic-d3 Acid; Deuterated N-Acetyl-5-aminosalicylic Acid; N-Acetyl-5-ASA-d3; Acetyl Mesalazine-D3; 5-Acetamidosalicylic Acid-D3; N-Acetyl Mesalamine (tri-deuterated); Internal Standard for Mesalamine-D3; 5-ASA N-Acetyl Derivative-D3
EINECS	Contact for details

Quality Control

Our n-Acetyl Mesalamine-D3 is manufactured under strict quality systems to ensure exceptional isotopic purity and chemical integrity. Each batch is supported by a comprehensive Certificate of Analysis (COA) detailing results for isotopic enrichment (D3, by NMR or MS), chemical purity (by HPLC), and identity confirmation. We adhere to relevant industry guidelines for reference standards to ensure reliable and reproducible performance in your analytical methods.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as specified on the certificate of analysis. Keep the container in a dry environment to minimize moisture uptake.

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 (D3)	≥98.0 atom % D
Chemical Purity (by HPLC)	≥95.0%
Residual Solvents (GC)	Complies with ICH limits
Water Content (KF)	≤1.0%

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