Description

Balsalazide is a prodrug of mesalamine (5-aminosalicylic acid) specifically designed for targeted delivery to the colon. This compound is of significant commercial importance as a key active pharmaceutical ingredient (API) in the treatment of inflammatory bowel diseases, such as ulcerative colitis. It is primarily required by pharmaceutical manufacturers and research institutions engaged in the development and production of specialized gastrointestinal therapeutics. The global market for Balsalazide CAS NO 80573-04-2 demands high-purity material that meets stringent pharmacopeial standards.

Application

• Primary Active Pharmaceutical Ingredient (API): Core component in the formulation of oral medications for ulcerative colitis.
• Pharmaceutical R&D: Used in research for developing new dosage forms and drug delivery systems targeting the lower gastrointestinal tract.
• Generic Drug Manufacturing: Essential for companies producing generic versions of balsalazide disodium-based drugs.
• Clinical Trial Material: Sourced for use as a reference standard or bulk active in clinical studies.
• Analytical Standard: Serves as a high-purity reference compound in quality control laboratories for HPLC, UV, and other analytical methods.

Basic Information

Product Name	Balsalazide
CAS No.	80573-04-2
Molecular Formula	C17H15N3O6
Molecular Weight	357.32 g/mol
Synonyms	Balsalazide; Balsalazide Free Acid; 5-[[4-[(2-Carboxyethyl)carbamoyl]phenyl]azo]salicylic Acid; 5-[[p-(2-Carboxyethylcarbamoyl)phenyl]azo]salicylic Acid; (E)-5-((4-((2-Carboxyethyl)carbamoyl)phenyl)diazenyl)-2-hydroxybenzoic Acid; BX 661A; BX-661A; Benzoic acid, 5-[[4-[(2-carboxyethyl)amino]carbonyl]phenyl]azo]-2-hydroxy-
EINECS	Contact for details

Quality Control

Our Balsalazide is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure it meets high-purity standards, typically exceeding 98.5% by HPLC. We provide full traceability and support compliance with cGMP, ICH Q7 guidelines, and major pharmacopeia requirements. A detailed Certificate of Analysis (COA) is provided with every shipment, confirming identity, purity, and impurity profiles.

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 material is hygroscopic (moisture-sensitive) and must be kept in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	Yellow to orange-yellow powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	98.5% - 101.0%
Water Content (KF)	≤ 2.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Total impurities ≤ 1.5% Any single impurity ≤ 0.5%

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