Description

Olsalazine Sodium is a pharmaceutical active ingredient and a prodrug of mesalamine (5-aminosalicylic acid). This compound is specifically designed for targeted delivery in the lower gastrointestinal tract, where it exerts a localized anti-inflammatory effect. It is primarily utilized in the formulation of oral medications for the treatment of chronic inflammatory bowel diseases, such as ulcerative colitis. Our supply ensures high purity and consistent quality, meeting the stringent demands of global pharmaceutical manufacturing.

Application

• Pharmaceutical Active Ingredient (API): Primary use in the formulation of oral solid dosage forms like tablets and capsules for the treatment of ulcerative colitis and Crohn's disease.
• Prodrug Development: Serves as a model compound in research focused on colon-specific drug delivery systems and prodrug strategies.
• Anti-inflammatory Agent: Used in pharmacological studies investigating localized treatments for gastrointestinal inflammation.
• Reference Standard: Employed as a high-purity chemical reference standard in analytical laboratories for quality control and method development.
• Clinical Research: Key material in pre-clinical and clinical trials for developing new therapeutic regimens for inflammatory bowel disease (IBD).
• Generic Drug Manufacturing: Essential for the production of generic versions of olsalazine sodium-based medications, ensuring cost-effective treatment options.

Basic Information

Product Name	Olsalazine Sodium
CAS No.	6054-98-4
Molecular Formula	C14H8N2Na2O6
Molecular Weight	346.20 g/mol
Synonyms	Disodium azodisalicylate; 3,3'-Azobis(6-hydroxybenzoic acid) disodium salt; Dipentum (brand name); Azodisal sodium; Olsalazine disodium; Sodium olsalazine; 5,5'-Azodi(salicylic acid) disodium salt
EINECS	227-977-8

Quality Control

Our Olsalazine Sodium is manufactured under strict quality management systems. Each batch is tested to ensure it meets high-purity standards suitable for pharmaceutical applications. A comprehensive Certificate of Analysis (COA) is provided, detailing results for identity, assay, purity, and specified impurities. We can support compliance with major pharmacopoeial standards such as USP and EP upon request.

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 using desiccants.

Specification

Item	Specification
Appearance	Yellow to orange-yellow crystalline powder
Identification (IR)	Conforms to reference spectrum
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 5.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH guidelines
Heavy Metals	≤ 20 ppm
Microbial Enumeration	Meets Ph. Eur. 2.6.12 / USP <61> requirements

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