Please note, this OEL/ADE monograph also applies to estradiol acetate (CAS RN 4245-41-4) and estradiol hemihydrate (CAS RN 35380-71-3). Estradiol is indicated for multiple conditions of menopause, metastatic breast cancer, prostate cancer, ovarian failure, and prevention of osteoporosis. Estrogens regulate the transcription of a limited number of genes and act through binding to nuclear receptors in estrogen-responsive tissues. Estrogens also modulate the pituitary secretion of the gonadotropins, luteinizing hormone (LH) and follicle stimulating hormone (FSH), through a negative feedback mechanism reducing the levels of these hormones seen in postmenopausal women.
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 and the acceptable surface limit (ASL).
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), and to obtain the following information:
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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.