Please note, this OEL/ADE monograph also applies to 4-aminosalicylic acid sodium dihydrate (CAS RN 6018-19-5). 4-Aminosalicylic acid, also known as para-aminosalicylic acid (PAS), is an anti-mycobacterial second line medication indicated for the treatment of active tuberculosis. It is also indicated as part of an appropriate combination regimen with other anti-tuberculosis drugs (most often isoniazid or streptomycin) for multi-drug resistant tuberculosis (MDR-TB) in adults and pediatrics patients from 28 days of age and older when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability. The sodium salt of aminosalicylic acid is better tolerated than the free acid.
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), as well as PIC/S and ANVISA requirements, and to obtain the following information:
To order an OEL/ADE monograph for 4-Aminosalicylic acid, just click the ADD TO CART button.
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Affygility Solutions’ 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.