Dinoprostone

Please note, this OEL/ADE monograph also applies to Dinoprostone tromethamine (CAS RN 54831-69-5). Dinoprostone is a naturally occurring prostaglandin E2 (PGE2). It has important effects in labor. It also stimulates osteoblasts to release factors which stimulate bone resorption by osteoclasts. Dinoprostone is indicated for the termination of pregnancy during the second trimester (from week 12 through week 20 of gestation as calculated from the first day of the last normal menstrual period), as well as for evacuation of the uterine contents in the management of missed abortion or intrauterine fetal death up to 28 weeks of gestational age as calculated from the first day of the last normal menstrual period. Dinoprostone is also used in the management of nonmetastatic gestational trophoblastic disease (benign hydatidiform mole). Other indications include improving the cervical inducibility (cervical "ripening") in pregnant women at or near term with a medical or obstetrical need for labor induction, and for the management of postpartum hemorrhage.

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, the acceptable surface limit (ASL), and the Permitted Daily Exposure (PDE) value.

Dinoprostone

CAS Registry Number:
363-24-6
Synonyms:
Synonyms, if needed
Trade names:
Trade names, if needed
Brand names:
Brand names, if needed
Cost:
$679 USD

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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

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

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  • K. Rosenthal
  • Director of Manufacturing