OEL Fastrac Catalog

Note, this OEL Fastrac monograph also covers the salt forms dextroamphetamine tannate (CAS RN 1407-85-8), dextroamphetamine hydrochloride (CAS RN 1462-73-3), dextroamphetamine tartrate (CAS RN 3994-11-4), dextroamphetamine phosphate (CAS RN 7528-00-9), dextroamphetamine adipate (CAS RN 64770-52-1), dextroamphetamine monosaccharate (CAS RN 799787-69-2), Dextroamphetamine sulfate (CAS RN 51-63-8), and Dextroamphetamine saccharate (CAS RN 350708-40-6). Dextroamphetamine is a stimulant used to treat narcolepsy and attention deficit disorder. Dextroamphetamine is the dextro (d-form) of amphetamine. Amphetamine is a central nervous system stimulant and sympathomimetic. Dextroamphetamine blocks the uptake of adrenergics and dopamine, stimulates the release of monoamines, and inhibits monoamine oxidase. Peripheral actions include elevations of systolic and diastolic blood pressure and weak bronchodilator and respiratory stimulant action.

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 Dextroamphetamine, just click the ADD TO CART button.

HBEL

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