Description

Balsalazide Disodium is a water-soluble, azo-bonded prodrug of 5-aminosalicylic acid (5-ASA) designed for targeted delivery to the colon. Its primary commercial value lies in its application as the active pharmaceutical ingredient (API) in medications for treating inflammatory bowel diseases, offering a mechanism to minimize systemic absorption and maximize therapeutic effect at the site of inflammation. This compound is essential for pharmaceutical manufacturers and R&D facilities focused on developing and producing advanced gastrointestinal therapeutics, particularly for ulcerative colitis.

Application

• Pharmaceutical API: Primary use as the active ingredient in prescription medications for the treatment of mild to moderate ulcerative colitis.
• Targeted Drug Delivery Systems: Utilized in formulations designed for colon-specific release, leveraging its azo-bond cleavage by colonic bacteria.
• Generic Drug Manufacturing: Sourcing for the production of generic versions of balsalazide disodium-based drugs.
• Pharmaceutical R&D: Serves as a key reference standard and starting material in research for novel IBD treatments and drug delivery mechanisms.
• Clinical Trial Material: Supply for pre-clinical and clinical studies investigating new formulations or expanded indications.

Basic Information

Product Name	Balsalazide Disodium
CAS No.	150399-21-6
Molecular Formula	C17H13N3Na2O6
Molecular Weight	407.28 g/mol
Synonyms	Balsalazide Disodium Salt; 5-[[(E)-2-Carboxy-5-[(E)-2-[4-[(2-Carboxyethyl)carbamoyl]phenyl]diazen-1-yl]phenyl]diazen-1-yl]-2-hydroxybenzoic Acid Disodium Salt; 2-Hydroxy-5-[(E)-2-{4-[(E)-2-(2-carboxyethylcarbamoyl)phenyl]diazen-1-yl}phenyl]diazen-1-yl]benzoic Acid Disodium Salt; BX 661A; BX-661A; Colazal (Brand Name); Giazo (Brand Name)
EINECS	Contact for details

Quality Control

Our Balsalazide Disodium is manufactured under strict quality systems. Each batch is tested to ensure it meets stringent specifications for identity, purity, and potency, aligning with ICH guidelines and current Good Manufacturing Practice (cGMP) standards. A comprehensive Certificate of Analysis (COA) detailing results for assay, related substances, residual solvents, and microbiological quality is provided with every shipment.

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.

Specification

Item	Specification
Appearance	Yellow to orange-yellow powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 5.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Heavy Metals	≤ 20 ppm
Microbiological Enumeration	Complies with Ph. Eur. 2.6.12/ USP <61>

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