Please note, this OEL/ADE monograph also applies to saw palmetto extract (CAS RN 84604-15-9). Saw palmetto (Serenoa repens) is a plant commonly found in costal environments of the southern states of the United States of America (USA), and in tropical Middle and South America. The plant is a bush with leaves of 18 to 24 sharp-ending segments. The flowers are on short branches and the fruit is a dark brown or blackish ovoid or subspherical drupe up to 2.5 cm long and 1.5 cm in diameter. The plant grows on dunes and pine forests. The ripe, partially dried berries, or drupes, are the source of the extract.
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 Serenoa repens, 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.