OEL Fastrac Catalog

Please note, this OEL/ADE monograph also applies to netilmicin (CAS RN 56391-56-1). Netilmicin is an aminoglycoside antibiotic indicated for the treatment of bacteremia, septicemia, respiratory tract infections, biliary tract infections, urinary tract infections, bone and joint infections, meningitis, ventriculitis, skin and soft-tissue infection, burns, wounds, and peri-operative infections caused by susceptible strains. Netilmicin sulfate is the sulfate salt form of netilmicin, a semisynthetic, water soluble aminoglycoside antibiotic. Its antibacterial activity is broad against aerobic gram-negative bacilli. It is not metabolized by most of the aminoglycoside-inactivating enzymes, and it therefore may be active against certain bacteria that are resistant to gentamicin. Netilmicin is derived from sisomicin, a naturally occurring aminoglycoside antibiotic produced by the fermentation of Micromonospora inyoensis. Netilmicin irreversibly binds to the 16S rRNA and S12 protein of the bacterial 30S ribosomal subunit. As a result, this agent interferes with the assembly of initiation complex between mRNA and the bacterial ribosome, thereby inhibiting the initiation of protein synthesis. In addition, netilmicin induces misreading of the mRNA template and causes a translational frameshift, thereby resulting in premature termination. This ultimately leads to bacterial cell death.

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 Netilmicin Sulfate, just click the ADD TO CART button.

HBEL

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