OEL Fastrac Catalog

Please note, this OEL/ADE monograph also applies to sultamicillin tosilate (CAS RN 83105-70-8). Sultamicillin tosilate is the salt form of sultamicillin. Sultamicillin is a double ester of sulbactam and ampicillin. Sultamicillin has been shown to be clinically effective in noncomparative trials in patients with infections of the respiratory tract, ears, nose and throat, urinary tract, skin and soft tissues, as well as in obstetric and gynecological infections, and in the treatment of gonorrhea. Sultamicillin is a double ester of sulbactam and ampicillin. The double ester form is orally bioavailable unlike the combination of sulbactam and ampicillin which is administered parenterally. Sultamicillin is hydrolyzed in the intestinal wall releasing sulbactam and ampicillin. The bactericidal activity of sultamicillin is primarily due to the ampicillin component of the molecule while the sulbactam component inhibits beta-lactamases.

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 Sultamicillin, just click the ADD TO CART button.

HBEL

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