Sulfasalazine is a sulfonamide antibiotic agent indicated for treatment of rheumatoid arthritis and ulcerative colitis. The mechanism of action of sulfasalazine may be related to the anti-inflammatory and immunomodulatory properties that have been observed in animal and in vitro models. Additionally, it has an affinity for connective tissue, and it reaches relatively high concentration in serous fluids, the liver and intestinal walls. In ulcerative colitis, clinical studies utilizing rectal administration of sulfasalazine have indicated that the major therapeutic action may be directly related to the 5-aminosalicylic acid moiety. The mechanism of action of the sulfasalazine is unknown.
Affygility Solutions has an occupational exposure limit (OEL) and control band assignment for this active pharmaceutical ingredient (API). This monograph also contains the acceptable daily exposure (ADE) value.
OEL Fastrac monographs are a cost-effective and convenient way to meet the requirements for PDEs (ADEs) contained in the EMA Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities (EMA/CHMP/CVMP/SWP/169430/2012), and to obtain the following information:
To order an OEL monograph for this compound, just click the ADD TO CART button.
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Affygility Solutions’s OEL Fastrac service is an user-friendly system that enables us to make confident decisions and focus on moving the compound safely through our facility. We can quickly access the database to determine if a new drug is within the OEL Fastrac library, and if so, immediately download a detailed OEL banding report. The OEL Fastrac system has been a helpful tool in our overall EH&S program.