OEL Fastrac Catalog

Please note, this OEL/ADE monograph also applies to theophylline hydrate (CAS RN 5967-84-0), theophylline magnesium (CAS RN 12286-42-9), theophylline sodium (CAS RN 3485-82-3), theophylline olamine (CAS RN 573-41-1), theophylline isopropanolamine (CAS RN 5600-19-1), theophylline sodium acetate (CAS RN 8002-89-9), theophylline ethylenediamine (CAS RN 5768-49-0), and theophylline sodium glycinate (CAS RN 8000-10-0). Theophylline is a methylxanthine indicated to treat asthma and chronic obstructive pulmonary disease. Theophylline exerts two distinct actions in the lungs; bronchodilation through smooth muscle relaxation and suppression of airway stimuli. The true mechanism of action has not been fully elucidated. However, it is suggested that bronchodilation is mediated by inhibition of two isoenzymes, phosphodiesterase (PDE III) and PDE IV while nonbronchodilation effects are mediated through other molecular mechanisms. Theophylline also appears to increase the force of contraction of diaphragmatic muscles through enhancement of calcium uptake through adenosine-mediated channels.

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 Theophylline, just click the ADD TO CART button.

HBEL

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