OEL Fastrac Catalog

Please note, this OEL/ADE monograph also applies to Ergonovine maleate (CAS RN 129-51-1), ergonovine hydrochloride (CAS RN 6034-13-5), ergonovine phosphate (CAS RN N.A.), and ergonovine tartrate (CAS RN 129-50-0). Ergonovine (also known as ergometrine) is a naturally occurring alkaloid found in ergot (Claviceps purpurea) and in Jacquemontia tamnifolia, Acremonium, and other organisms. In human medicine, ergometrine is used as a maleate salt to prevent or treat postpartum and postabortion hemorrhage. Ergometrine is used in the active management of the third stage of labor. It is used in veterinary medicine in the control of postpartum uterine hemorrhage, removal of fluid from atonic uteri, to prevent prolapsed uteri, and judiciously in terms of timing to aid in suturing the uterus after cesarean section or in replacing an everted uterus.

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.

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 Ergonovine, just click the ADD TO CART button.

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