Mesalazine API, also known as Mesalamine or 5-Aminosalicylic Acid (5-ASA), is a pharmaceutical-grade Active Pharmaceutical Ingredient (API) belonging to the aminosalicylate class. Chemically known as 5-amino-2-hydroxybenzoic acid, Mesalazine has the molecular formula C₇H₇NO₃, molecular weight 153.14 g/mol, and CAS Number 89-57-6. MEDIOCON INC supplies high-quality Mesalazine API for pharmaceutical formulation, manufacturing, and bulk API requirements.
Mesalazine is widely used in pharmaceutical formulations as an aminosalicylate anti-inflammatory ingredient, particularly for products intended for the management of ulcerative colitis and inflammatory bowel disease. It is available in various pharmaceutical dosage forms, including gastro-resistant tablets, prolonged-release preparations, granules, suppositories, enemas, and foam formulations. Its pharmaceutical applications make it an important API for gastrointestinal therapeutic product development.
MEDIOCON INC offers Mesalazine API with pharmaceutical-quality specifications and supporting documentation according to applicable customer and regulatory requirements. Product documentation such as Certificate of Analysis (COA), MSDS/SDS, and technical specifications can be provided for qualified bulk API requirements.
| Parameter | Specification |
|---|---|
| Appearance | Almost white, light grey or light pink powder or crystals |
| Identification | IR / UV / TLC Compliant |
| Assay (HPLC) | 98.5% – 101.5% |
| Loss on Drying | NMT 0.5% |
| Residue on Ignition | NMT 0.2% |
| Individual Impurity | NMT 0.30% |
| Total Impurities | NMT 0.50% |
| Water Content | NMT 0.5% |
| Melting Point | 275°C – 280°C |
| Solubility | Very slightly soluble in water |
Mediocon Inc is a GMP-certified API manufacturer and bulk pharmaceutical ingredient supplier based in Aurangabad, Maharashtra, India. We specialise in supplying Mesalazine API Manufacturer & Supplier in India | MEDIOCON INC (CAS 89-57-6) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.
Our Mesalazine API Manufacturer & Supplier in India | MEDIOCON INC is manufactured under strict quality management protocols compliant with WHO-GMP, ISO 9001:2015, and major pharmacopoeial standards (IP, BP, USP, EP). Every batch undergoes full analytical testing before release with a Certificate of Analysis.
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