Mesalamine
General Information
Mesalamine Impurities and Mesalamine
Daicel Pharma offers superior-quality Mesalamine impurities, such as 3,5-diamino-2-hydroxybenzoic acid Hydrochloride and 5-[2-formyl-5-(hydroxymethyl)-1h-pyrrol-1-yl]-2-hydroxybenzoic acid. These impurities are essential for evaluating Mesalamine quality, stability, and biological safety. In addition, Daicel Pharma specializes in the custom synthesis of Mesalamine impurities and ensures worldwide delivery.
Mesalamine [CAS: 89-57-6] or 5-aminosalicylic acid, treats patients with inflammatory bowel disease (IBD). It is an active metabolite of sulfasalazine. It is an anti-inflammatory drug that stops the generation of arachidonic acid metabolites, causing mucosal production. It inhibits cyclooxygenase and prostaglandin production in the colon for bowel inflammation.
Mesalamine: Use and Commercial Availability
Mesalamine treats patients with inflammatory bowel disease (IBD) and ulcerative colitis. It relieves symptoms associated with IBD. It combines with other medicines to treat extensive mild-to-moderate ulcerative colitis. Further, it helps in remission maintenance in ulcerative colitis. Mesalamine is available in different formulations, such as tablets or rectal suppositories. Many companies prepare Mesalamine under various brands, such as Apriso, Canasa, Delzicol, Pentasa, etc.
Mesalamine Structure and Mechanism of Action
The chemical name of Mesalamine is 5-Amino-2-hydroxybenzoic acid. The chemical formula for Mesalamine is C7H7NO3, and its molecular weight is approximately 153.14 g/mol.
The precise mechanism of action of Mesalamine is unknown.
Mesalamine Impurities and Synthesis
While synthesizing Mesalamine, the formation of impurities may affect drug safety and efficacy. They form during the synthetic process, storage, or purification of Mesalamine. Manufacturers can control and monitor Mesalamine impurities to improve the drug’s safety, efficacy, and storage.
Daicel Pharma offers a comprehensive Certificate of Analysis (CoA) for Mesalamine impurities, which includes 3,5-diamino-2-hydroxybenzoic acid Hydrochloride and 5-[2-formyl-5-(hydroxymethyl)-1h-pyrrol-1-yl]-2-hydroxybenzoic acid. The CoA offered to clients is from a cGMP-compliant analytical facility, with complete characterization data such as 1H NMR, 13C NMR, IR, MASS, and HPLC purity1,2. We give additional spectral data on request. Daicel Pharma can prepare any unidentified Mesalamine impurity or degradation product. In addition, Daicel Pharma offers highly purified, stable isotope-labeled standards of Mesalamine. Daicel Pharma provides a complete characterization report accompanying the delivery.
References
FAQ's
References
- Fischer, C.; Maier, K.; Klotz, U., Simplified high-performance liquid chromatographic method for 5-aminosalicyclic acid in plasma and urine, Journal of Chromatography, Biomedical Applications, Volume: 225, Issue: 2, Pages: 498-503, 1981 DOI: (1016/s0378-4347(00)80303-5)
- Kersten, Brian S.; Catalano, Tom; Rozenman, Yury, Ion-pairing high-performance liquid chromatographic method for the determination of 5-aminosalicylic acid and related impurities in bulk chemical, Journal of Chromatography, Volume: 588, Issue: 1-2, Pages: 187-93, 1991 DOI: (10.1016/0021-9673(91)85022-8)
Frequently Asked Questions
What causes the formation of Mesalamine impurities?
Side reactions and by-products formed during the synthetic process are the source of Mesalamine impurities.
What is the analytical method to analyze the presence of residual solvents in the Mesalamine drug?
Head Space Gas Chromatography helps analyze the presence of residual solvents in the Mesalamine drug.
Why do we need to identify and remove Mesalamine impurities from the drug?
The presence of Mesalamine impurities in the drug can affect its efficacy and safety. These impurities are harmful to human health, and hence, their removal is essential.
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