OEL Fastrac Catalog

Please note, this OEL/ADE monograph also applies to cloxacillin sodium (CAS RN 642-78-4), cloxacillin benzathine (CAS RN 23736-58-5) and cloxacillin sodium salt monohydrate (CAS RN 7081-44-9). Cloxacillin is an effective antimicrobial for gram-positive infections, specifically Staphylococcus aureus. The drug has been used to treat respiratory, skin and soft tissue, pharyngeal, and heart shunt infections. In addition, cloxacillin can also be used for acute bone infection. Cloxacillin sodium is a semi-synthetic, penicillinase-resistant penicillin of the isoxazolyl penicillin group. It binds to the penicillin binding proteins of susceptible bacteria. Cloxacillin is remarkably resistant to cleavage by penicillinase, and is a potent inhibitor of the proliferation of penicillinase-producing staphylococci. Like other beta-lactam antibiotics, cloxacillin inhibits the final transpeptidation step of peptidoglycan synthesis in gram-positive bacterial cell walls, thus inhibiting cell wall biosynthesis. It is thought that penicillins inactivate transpeptidase via acylation of the enzyme, forming penicilloyl enzyme with cleavage of the CO-N bond of the beta-lactam ring.

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 Cloxacillin, just click the ADD TO CART button.

HBEL

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