Please note, this OEL/ADE monograph also applies to alternatue CAS RN 604-09-1, hydroxyprogesterone caproate (CAS RN 630-56-8), and hydroxyprogesterone heptanoate (CAS RN 4596-16-1 and 120793-91-1). Hydroxyprogesterone (also known as 17-hydroxyprogesterone and 17-alpha hydroxyprogesterone) is a physiological progestin that is produced during glucocorticoid and steroid hormone synthesis and levels are increased during the third trimester of pregnancy. Hydroxyprogesterone caproate (also known as 17-alpha hydroxyprogesterone caproate) is an ester derivative of hydroxyprogesterone formed from caproic acid (hexanoic acid). It is a synthetic progestational agent similar to the endogenous progesterone used in hormone therapy or as a female contraceptive. Hydroxyprogesterone caproate is indicated for the prevention of spontaneous preterm births in singleton pregnancies in women who have previously had a spontaneous preterm birth. Hydroxyprogesterone caproate is also indicated for the treatment of endometrial cancer, management of amenorrhea and abnormal uterine bleeding, and for the production of secretory endometrium and desquamation. In the United States (US), hydroxyprogesterone was withdrawn from marketing for those indications.
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:
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