OEL Fastrac Catalog

Please note, this OEL/ADE monograph also applies to prednisolone (CAS RN 50-24-8), pethylprednisolone (CAS RN 83-43-2), prednisolone sodium phosphate (CAS RN 125-02-0), prednisolone 21-trimethylacetate (CAS RN 1107-99-9), prednisolone acetate (CAS RN 52-21-1), prednisolone hemisuccinate (CAS RN 2920-86-7), prednisolone sodium metazoate (CAS RN 630-67-1), prednisolone sodium succinate (CAS RN 1715-33-9), prednisolone steaglate (CAS RN 5060-55-9), prednisolone tebutate (CAS RN 681-14-3), prednisone acetate (CAS RN 125-10-0), and prednisolone farnesylate (CAS RN 118244-44-3). Prednisone is a synthetic glucocorticoid with anti-inflammatory and immunomodulating properties (2). Prednisone is indicated as an anti-inflammatory or immunosuppressive drug for allergic, dermatologic, gastrointestinal (GI), hematologic, ophthalmologic, nervous system, renal, respiratory, rheumatologic, infectious, endocrine, or neoplastic conditions as well as in organ transplant. Prednisone is therapeutically equivalent to its metabolite, prednisolone.

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 Prednisone, just click the ADD TO CART button.

HBEL

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