OEL Fastrac Catalog

Please note, this OEL/ADE monograph also applies to betamethasone acetate (CAS RN 987-24-6), betamethasone benzoate (CAS RN 22298-29-9), betamethasone dipropionate (CAS RN 5593-20-4), betamethasone sodium phosphate (CAS RN 151-73-5), betamethasone valerate (CAS RN 2152-44-5), betamethasone butyrate propionate (CAS RN 5534-02-1), betamethasone phosphate (CAS RN 360-63-4) and betamethasone acibutate (CAS RN 5534-05-4). Betamethasone sodium phosphate, in combination with betamethasone acetate, is indicated for the control of severe allergic reactions, dermatologic diseases, endocrine disorders, rheumatic disorders, hematologic disorders, neoplastic diseases, edematous states, gastrointestinal diseases, tuberculosis meningitis, and trichinosis. Betamethasone valerate (the 17-valerate derivative of betamethasone) is a topical synthetic adrenocorticosteroid indicated for the relief of the inflammatory and itching (pruritic) manifestations of corticosteroid-responsive skin diseases (dermatoses).

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 Betamethasone, just click the ADD TO CART button.

HBEL

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