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 In the United States (US), hydroxyprogesterone was withdrawn from marketing for those indications.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.


CAS Registry Number:
Brand names:
Hylutin®, Prodrox®, Makena®
$679 USD


Why do you need this OEL Fastrac monograph?

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:

  • The numerical OEL and control band assignment needed to determine the level of required engineering controls and personal protective equipment
  • A listing of all cited references utilized in the derivation of the OEL and ADE
  • An expert review and discussion with respect to the critical endpoints of concern, the rationale for the choice of endpoints, and dose that is to be used in the derivation of the ADE (PDE), as required by the EMA's Guideline on setting health-based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities

Benefits of OEL Fastrac monographs

  • Fully documented. Over 20 pages in length, with calculations and cited references.
  • Save time! Unsurpassed delivery with instant download.
  • Save money. Similar documents cost 5-12 times as much.
  • Stay current. Automatic notification of revisions.

How to order

To order an OEL/ADE monograph for Hydroxyprogesterone, just click the ADD TO CART button.


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Affygility Solutions’ 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.
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  • Director of Manufacturing