OEL Fastrac Catalog

Please note, this OEL/ADE monograph also applies to methylprednisolone acetate (CAS RN 53-36-1), methylprednisolone aceponate (CAS RN 86401-95-8), methylprednisolone sodium phosphate (CAS RN 5015-36-1), methylprednisolone sodium succinate (2375-03-3), methylprednisolone suleptanate (CAS RN 90350-40-6), and methylprednisolone hemisuccinate (CAS RN 2921-57-5). Methylprednisolone acetate is indicated for intramuscular (IM) use when oral therapy is not feasible for the treatment of various endocrine, rheumatic, collagen, dermatologic, allergic, ophthalmic, gastrointestinal, respiratory, hematologic, neoplastic, edematous, and nervous system states, disorders, and diseases. Methylprednisolone acetate is a synthetic corticosteroid with prolonged anti-inflammatory and immunomodulating properties. Methylprednisolone binds to and activates specific nuclear receptors resulting in altered gene expression and inhibition of proinflammatory cytokine production. Methylprednisolone acetate also decreases the number of circulating lymphocytes, induces cell differentiation, and stimulates apoptosis in sensitive tumor cell populations.

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 Methylprednisolone, just click the ADD TO CART button.

HBEL

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