Description

Balsalazide Disodium is a high-purity active pharmaceutical ingredient (API) and a key prodrug of mesalamine (5-aminosalicylic acid). It is specifically designed for targeted delivery to the colon, where it exerts a potent local anti-inflammatory effect. This compound is essential for the formulation of pharmaceutical products used in the treatment of inflammatory bowel diseases, particularly ulcerative colitis. We supply Balsalazide Disodium CAS NO 213594-60-6 to global manufacturers seeking reliable, high-quality API for their finished dosage forms.

Application

• Primary Pharmaceutical API: The core active ingredient in prescription medications for the treatment of mild to moderate ulcerative colitis.
• Oral Solid Dosage Forms: Used in the manufacturing of capsules and tablets designed for colon-specific drug release.
• Prodrug Development: Serves as a model prodrug in pharmaceutical R&D for studying targeted drug delivery systems to the lower gastrointestinal tract.
• Reference Standard: Employed as a certified reference material (CRM) in analytical laboratories for quality control and method validation.
• Clinical Trial Materials (CTM): Supplied for use in the production of investigational medicinal products during clinical development phases.
• Generic Drug Manufacturing: A critical component for companies developing bioequivalent versions of branded ulcerative colitis treatments.

Basic Information

Product Name	Balsalazide Disodium
CAS No.	213594-60-6
Molecular Formula	C17H13N3Na2O6
Molecular Weight	407.28 g/mol
Synonyms	Balsalazide Disodium Salt; 5-[[(E)-2-Carboxy-2-(2-hydroxybenzoyl)hydrazin-1-ylidene]methyl]-2-hydroxybenzoic Acid Disodium Salt; 5-[[4-[(2-Carboxy-2-hydroxybenzoyl)amino]benzoyl]amino]-2-hydroxybenzoic Acid Disodium Salt; BX 661A; BX-661A; Colazide (trade name); Giazo (trade name)
EINECS	Contact for details

Quality Control

Our Balsalazide Disodium is manufactured under strict quality management systems. It is produced to meet high-purity standards suitable for pharmaceutical applications, with typical purity levels exceeding 99.0% (by HPLC). Each batch is supported by a comprehensive Certificate of Analysis (COA) detailing identity, purity, and impurity profiles. We can supply material that aligns with relevant pharmacopeial monographs, and specifications can be tailored to meet specific customer requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	Yellow to orange-yellow powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 99.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.2%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Individual impurity ≤ 0.5%; Total impurities ≤ 1.5%
Microbial Limits	Meets Ph. Eur./USP requirements

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