Description

Balsalazide-D3 Disodium Salt is a deuterated isotopologue of the active pharmaceutical ingredient balsalazide disodium, specifically designed for use as an internal standard in quantitative bioanalytical methods. This high-purity reference material is critical for ensuring the accuracy and reliability of pharmacokinetic and metabolic studies, eliminating variability and enhancing data integrity. It is an essential tool for pharmaceutical R&D laboratories, contract research organizations (CROs), and analytical service providers focused on the development and quality control of gastrointestinal therapeutics.

Application

• Primary use as an Internal Standard (IS) in Liquid Chromatography-Mass Spectrometry (LC-MS/MS) and High-Performance Liquid Chromatography (HPLC) methods for the quantification of balsalazide and its metabolites.
• Critical component in pharmacokinetic (PK) and bioequivalence studies to determine drug absorption, distribution, metabolism, and excretion (ADME) profiles.
• Essential for method development and validation in regulatory-compliant bioanalysis, supporting FDA, EMA, and ICH guidelines.
• Used in drug metabolism research to track and quantify deuterated vs. non-deuterated compound ratios with high precision.
• Application in quality control laboratories for the analysis of active pharmaceutical ingredients (APIs) and finished drug products containing balsalazide.
• Supporting material for clinical trial research involving ulcerative colitis treatments, ensuring accurate measurement of drug concentrations in biological matrices.

Basic Information

Product Name	Balsalazide-D3 Disodium Salt
CAS No.	1246834-21-8
Molecular Formula	C17H10D3N4Na2O6
Molecular Weight	403.30 g/mol (approximate)
Synonyms	5-[[4-[(2-Carboxyethyl)diazenyl]phenyl]carbonyl-d3]amino]-2-hydroxybenzoic Acid Disodium Salt; Balsalazide-d3 Disodium; Deuterated Balsalazide Disodium Salt; Balsalazide (Phenyl-d3) Disodium Salt; Colazal-d3 (Reference Standard); Balsalazide Internal Standard; 2-Hydroxy-5-[(4-[(E)-2-(sodiooxy)-2-oxoethyl]diazenyl]benzoyl-d3]amino]benzoic Acid Sodium Salt
EINECS	Contact for details

Quality Control

Every batch of our Balsalazide-D3 Disodium Salt is manufactured under strict quality management systems and undergoes comprehensive analytical testing. We guarantee high chemical and isotopic purity suitable for sensitive analytical applications. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting results for identity, purity (by HPLC), isotopic enrichment, and residual solvents. Our quality commitment aligns with the standards expected for pharmaceutical reference materials.

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. This compound is hygroscopic (moisture-sensitive); protect from humidity and store in a dry environment.

Specification

Item	Specification
Appearance	Yellow to orange-yellow powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥98.0%
Isotopic Purity (deuterium, D)	≥98.0 atom % D
Water Content (KF)	≤5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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