Please note, this OEL/ADE monograph also applies to methyl aminolevulinate hydrochloride (CAS RN 79416-27-6). Methyl aminolevulinate is a prodrug that is metabolized to protoporphyrin IX (a photosensitizer) used in photodynamic therapy. Methyl aminolevulinate hydrochloride is indicated for topical use, in combination with 570 nm to 670 nm wavelength red light illumination, in the treatment of non-hyperkeratotic actinic keratoses (AK) of the face and scalp in immunocompetent patients when used in conjunction with lesion preparation (debridement using a sharp dermal curette).
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 Methyl Aminolevulinate, 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.