OEL Fastrac Catalog

Please note, this OEL/ADE monograph also applies to caffeine bromide (CAS RN 5743-18-0), caffeine monohydrate (CAS RN 5743-12-4), caffeine citrate (CAS RN 69-22-7), Caffeine benzoate (CAS RN 5743-17-9) and caffeine hydrochloride (CAS RN 5892-18-2). Caffeine is xanthine alkaloid that occurs naturally in seeds, leaves and fruit of several plants and trees that acts as a natural pesticide. Caffeine is a stimulant present in tea, coffee, cola beverages, analgesic drugs, and agents used to increase alertness. It is also used as medication for treatment of apnea of prematurity. Its effect has been well established in reducing the frequency of apnea, intermittent hypoxemia, and extubation failure in mechanically ventilated preterm infants. Caffeine is also used in a variety of cosmetic products. In addition, caffeine is indicated in combination with sodium benzoate to treat respiratory depression resulting from an overdose with a central nervous system (CNS) depressant drug. Caffeine is available as solution for intravenous (IV) injection, as tablets, capsules, syrup, lozenges, granules, powder for solution, and solution for oral administration, and as liquid and cream for topical administration.

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 Caffeine, just click the ADD TO CART button.

HBEL

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