OEL Fastrac Catalog

Please note, this OEL/ADE monograph also applies to mepacrine hydrochloride (CAS RN 69-05-6), mepacrine dihydrochloride dihydrate (CAS RN 6151-30-0), Mepacrine mesilate (CAS RN 316-05-2), Mepacrine methanesulfonate monohydrate (CAS RN 6598-46-5), and Quinacrine mustard (CAS RN 64046-79-3; 4213-45-0). Mepacrine, also known as quinacrine, is an acridine derivative used as an anthelmintic indicated for the treatment of giardiasis and cutaneous leishmaniasis and the management of malignant effusions. It was previously used as an antimalarial agent. Mepacrine is no longer used as an antimalarial agent. It has been most recently used in cutaneous lupus erythematosus. The antiparasitic mechanism of action of mepacrine is not known. Mepacrine binds to DNA in vitro by intercalation between adjacent base pairs, inhibiting transcription and translation to RNA. Studies suggest that mepacrine does not localize to the nucleus of Giardia trophozoites and therefore, DNA binding may not be the primary mechanism of its antimicrobial action; the outer membrane may be involved, however. Mepacrine inhibits succinate oxidation and interferes with electron transport. Additionally, by binding to nucleoproteins, it suppresses the lupus erythematous cell factor and acts as a strong inhibitor of cholinesterase.

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 Mepacrine, just click the ADD TO CART button.

HBEL

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