Isotretinoin is indicated for the treatment of severe recalcitrant nodulocystic acne. Isotretinoin also known as 13-cis retinoic acid, is classified as a retinoid, which is a synthetic analogue of vitamin A. Its exact mechanism of action is not known. When administered in pharmacologic dosages, isotretinoin inhibits sebaceous gland function and keratinization. In nodular acne, clinical improvement is associated with a reduction in sebum secretion which is related to the dose and duration of isotretinoin treatment. Retinoids affect the keratinization process, and therefore without specificity exhibit effectiveness in all types of hyperkeratotic conditions.
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 Isotretinoin, just click the ADD TO CART button.
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Not the compound you were looking for? You can search the OEL Fastrac catalog to find more available compounds.
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.