OEL Fastrac Catalog

Please note, this OEL/ADE monograph also applies to ractopamine hydrochloride (CAS RN 90274-24-1). Ractopamine a veterinary growth stimulant indicated for increased weight gain, improved feed efficiency, and increased carcass leanness in finishing swine weighing not less than 150 lb and fed at least 16% crude proteins for the last 45 to 90 lb of gain prior to slaughter. Ractopamine exists as a racemic mixture of four stereoisomers with β2 adrenergic agonist activity. The RR isomer is a potent cardiostimulant in humans and is likely the functional and most active stereoisomer accounting for the growth response in pigs.

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 Ractopamine, just click the ADD TO CART button.

HBEL

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