Please note, this OEL/ADE monograph also applies to aminolevulinic hydrochloride (CAS RN 5451-09-2). 5-Aminolevulinic acid, also known as aminolevulinic acid (ALA), is the simplest delta-amino acid in which the hydrogens at the gamma position are replaced by an oxo group. It is metabolized to protoporphyrin IX (PpIX), a photoactive compound which accumulates in the skin. 5-Aminolevulinic acid, as its hydrochloride salt, is indicated for the treatment of single and multiple non-hyperkeratotic actinic keratoses of the face and scalp with blue light irradiation . Aminolevulinic acid is also indicated for patients with glioma as an adjunct for the visualization of malignant tissue during surgery (6). This is for patients with suspected World Health Organization (WHO) Grades III or IV on preoperative imaging.
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 5-Aminolevulinic acid, 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.