OEL Fastrac Catalog

Please note, this OEL/ADE monograph also applies to Kanamycin sulfate (complex) (CAS RN 25389-94-0), Kanamycin sulfate hydrate (CAS RN 5965-95-7), Kanamycin acid sulfate (CAS RN 64013-70-3), Kanamycin A sulfate (CAS RN 3847-27-6), Kanamycin C (CAS RN 2280-32-2), Kanamycin monopantothenate (CAS 17899-71-7), Kanamycin dipantothenate (CAS RN 17899-96-6), Bekanamycin (kanamycin B) (CAS RN 4696-76-8), and Bekanamycin (kanamycin B) sulfate (CAS RN 29701-07-3). Kanamycin is an antibiotic complex produced by Streptomyces kanamyceticus. It consists of 3 components kanamycin A, the major component, and kanamycins B and C, the minor components. It has been used in the treatment of susceptible gram-negative and staphylococcal infections, including gonorrhea and neonatal gonococcal eye infections, although its use has declined in many centers because of the development of resistance.

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 Kanamycin, just click the ADD TO CART button.

HBEL

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