Description

Balsalazide Disodium is a high-purity pharmaceutical active ingredient, a prodrug of mesalamine (5-aminosalicylic acid) specifically designed for targeted delivery to the colon. Its primary commercial value lies in its application as the key therapeutic agent in the treatment of ulcerative colitis and other inflammatory bowel diseases. This compound is essential for pharmaceutical manufacturers developing oral dosage forms, particularly enteric-coated tablets and capsules, for the global gastrointestinal therapeutics market.

Application

• Pharmaceutical Active Ingredient (API): Primary use as the core therapeutic agent in prescription medications for ulcerative colitis.
• Enteric-Coated Formulations: Specifically formulated for delayed-release oral dosage forms that deliver the drug to the colon.
• Anti-inflammatory Bowel Disease (IBD) Drugs: Used in the development and production of drugs targeting mild to moderate ulcerative colitis.
• Generic Drug Manufacturing: Serves as the critical API for generic versions of branded balsalazide disodium medications.
• Clinical Research & Development: Utilized in preclinical and clinical studies for new IBD treatment formulations.
• Pharmaceutical Intermediates: Acts as a key intermediate in specific synthetic pathways for related salicylate-based therapeutics.

Basic Information

Product Name	Balsalazide Disodium
CAS No.	82101-18-6
Molecular Formula	C17H13N3Na2O6
Molecular Weight	401.28 g/mol
Synonyms	Balsalazide Disodium Salt; (E)-5-[[4-[[(2-Carboxyethyl)amino]carbonyl]phenyl]azo]-2-hydroxybenzoic Acid Disodium Salt; Balsalazide Sodium; Balsalazine Disodium; Colazide (Trade Name); BX 661A; BX-661A; 2-Hydroxy-5-[(E)-2-{4-[(2-sulfonatoethyl)carbamoyl]phenyl}diazen-1-yl]benzoate Disodium
EINECS	Contact for details

Quality Control

Our Balsalazide Disodium is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure it meets stringent specifications for pharmaceutical use, including identity, purity, and impurity profiles. We provide full traceability and Certificates of Analysis (COA) are available for every shipment, supporting compliance with cGMP and major pharmacopoeial standards (USP/EP) as required.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry, and well-ventilated place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed after each use to prevent degradation from atmospheric moisture.

Specification

Item	Specification
Appearance	Yellow to orange-yellow powder
Identification (IR)	Conforms
Identification (HPLC)	Conforms
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.2%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Individual impurity ≤ 0.5%; Total impurities ≤ 2.0%
Microbial Limits	Conforms to USP <61> and <62>

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