Please note, this OEL/ADE monograph also applies to Norethindrone acetate (CAS RN 51-98-9) and norethindrone enanthate (CAS RN 3836-23-5). Norethindrone, also know as norethisterone, is a synthetic progestin indicated for the treatment of amenorrhea, endometriosis, abnormal uterine bleeding due to hormonal imbalance, vulvar and vaginal atrophy due to menopause, and in combination with estradiol as a contraceptive. Progestins diffuse freely into target cells, including the female reproductive tract, the mammary gland, the hypothalamus, and the pituitary gland, and bind to the progesterone receptor.
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), as well as PIC/S and ANVISA requirements, and to obtain the following information:
To order an OEL/ADE monograph for Norethindrone, 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.