OEL Fastrac Catalog

Please note, this OEL/ADE monograph also applies to sarecycline hydrochloride (CAS RN 1035979-44-2). Sarecycline is a tetracycline-class drug indicated for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 9 years of age and older. The mechanism of action of sarecycline is unknown. It has been demonstrated that tetracyclines, like sarecycline, elicit their antimicrobial action by targeting and inhibiting protein synthesis in microbial agents like Cutibacterium acnes present in acne lesions. It is thought that the action of sarecycline revolves around the inhibition of various macromolecular biosynthesis activities like the macromolecular biosynthesis of microbial DNA and proteins. While sarecycline demonstrates appreciable inhibition of microbial macromolecular DNA and protein synthesis, it has little to no effect on lipid biosynthesis, cell wall synthesis, and RNA synthesis. Additionally, it is thought that tetracyclines like sarecycline can also affect an anti-inflammatory effect via the inhibition of the synthesis of inflammatory proteins generated by Cutibacterium acnes.

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 Sarecycline, just click the ADD TO CART button.

HBEL

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