Description

Sulfasalazine-D4 is a high-purity, deuterium-labeled internal standard essential for precise quantitative analysis in pharmaceutical research and development. This stable isotope-labeled compound is critical for ensuring accuracy and reliability in mass spectrometry-based methods, such as LC-MS/MS, by correcting for analyte loss during sample preparation and instrument variability. It is primarily utilized by analytical laboratories, CROs, and pharmaceutical companies engaged in method development, pharmacokinetic studies, and quality control for the parent drug, Sulfasalazine.

Application

• Internal Standard for Bioanalysis: Used as a critical component in the quantification of Sulfasalazine and its metabolites in biological matrices (plasma, serum, urine) for pharmacokinetic and pharmacodynamic studies.
• Method Development & Validation: Serves as a reliable reference standard for developing and validating robust LC-MS/MS and HPLC analytical methods in compliance with GLP and GMP guidelines.
• Drug Metabolism Studies: Enables accurate tracking and measurement of drug metabolism pathways, aiding in the understanding of bioavailability and biotransformation.
• Quality Control & Assurance: Employed in pharmaceutical quality control laboratories to ensure the accuracy of assay results for Sulfasalazine active pharmaceutical ingredients (APIs) and finished dosage forms.
• Clinical Research: Supports clinical trial research by providing precise measurement of drug concentrations in patient samples, which is vital for determining safety and efficacy.
• Forensic & Doping Analysis: Applicable in specialized testing environments for the definitive identification and quantification of Sulfasalazine.

Basic Information

Product Name	Sulfasalazine-D4
CAS No.	1346606-50-5
Molecular Formula	C18H14D4N4O5S
Molecular Weight	402.44 g/mol
Synonyms	2-Hydroxy-5-[(E)-2-{4-[(pyridin-2-yl)sulfamoyl]phenyl}diazen-1-yl]benzoic-3,4,5,6-d4 acid; Salazosulfapyridine-D4; 5-([p-(2-Pyridylsulfamoyl)phenyl]azo)salicylic-3,4,5,6-d4 acid; Azulfidine-D4; Deuterated Sulfasalazine; Sulfasalazine (phenyl-d4); Sulfasalazine-d4
EINECS	Contact for details

Quality Control

Every batch of Sulfasalazine-D4 is manufactured and analyzed under strict quality management systems. We provide comprehensive Certificates of Analysis (COA) that detail critical parameters including isotopic purity (typically >98% D), chemical purity (by HPLC), and identification. Our quality commitment ensures the material is suitable for use as a certified reference standard in regulated environments, supporting compliance with ISO, GLP, and relevant pharmacopeial expectations.

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 light-sensitive; therefore, containers must be kept tightly sealed and desiccated to maintain stability and purity.

Specification

Item	Specification
Appearance	Yellow to orange crystalline powder
Identification (IR)	Conforms to structure
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity (D)	≥ 98 atom % D
Chemical Purity	≥ 95%
Water Content (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%

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