OEL Fastrac Catalog

Please note, this OEL/ADE monograph also applies to doxycycline hyclate (CAS RN 24390-14-5), doxycycline monohydrate (CAS RN 17086-28-1), doxycycline (CAS RN 10592-13-9), and doxycycline (CAS RN 94088-85-4). This monograph contains both the OEL and ADE. Doxycycline is a tetracycline derivative with uses similar to those of tetracycline (Tetracycline Phosphate Complex). It may be preferred to other tetracyclines in the treatment of sensitive infections because of its fairly reliable absorbtion and its long half-life which permits less frequent (often once daily) dosage. Doxycycline has antiprotozoal actions and may be given in conjunction with quinine in the management of falciparum malaria resistant to chloroquine (Doxycycline Hyclate). Tetracyclines are a broad spectrum bacteriostatic antibiotic. They are effective against rickettsia, spirochetes, mycoplasma, Bedsonia agents and susceptible strains of staphylococci, pneumococci, alpha and beta hemolytic streptococci, non-hemolytic streptococci and gram negative rods. The tetracyclines inhibit protein synthesis in susceptible organisms by preventing RNA translation. As chelating agents they interfere with calcium in bone and teeth.

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 Doxycycline, just click the ADD TO CART button.

HBEL

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