Norgestimate is the progestogenic component of combined oral contraceptives (COC) indicated for the prevention of pregnancy. The combination of norgestimate with ethinyl estradiol is indicated for the treatment of moderate acne vulgaris in females at least 15 years of age. Norgestimate is also used in combination with estradiol to treat the symptoms of menopause. Norgestimate, a synthetic form of the female sex hormone progesterone, binds to androgen and progestogen receptors on target cells in the female reproductive tract, the mammary gland, the hypothalamus, and the pituitary gland. Once bound, norgestimate will slow the frequency of release of gonadotropin releasing hormone (GnRH) from the hypothalamus and blunt the pre-ovulatory luteinizing hormone (LH) surge. COCs lower the risk of becoming pregnant primarily by suppressing ovulation. Changes in cervical mucus and the endometrium inhibit sperm penetration and reduce the likelihood of implantation.
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), and to obtain the following information:
To order an OEL/ADE monograph for Norgestimate, 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.