OEL Fastrac Catalog

Please note, this OEL/ADE monograph also applies to hydrocortisone acetate (CAS RN 50-03-3), hydrocortisone hemisuccinate hydrate (CAS RN 83784-20-7), hydrocortisone probutate (CAS RN 72590-77-3), hydrocortisone butyrate 119 mg (CAS 13609-67-1), hydrocortisone cypionate (CAS RN 508-99-6), hydrocortisone hemisuccinate anhydrous (CAS RN 2203-97-6); monohydrate CAS 83784- 20-7), hydrocortisone sodium phosphate (CAS RN 6000-74-4), hydrocortisone sodium succinate (CAS RN 125-04-2), hydrocortisone valerate (CAS RN 57524-89-7) and hydrocortisone aceponate (CAS RN 74050-20-7). Cortisol is a steroid hormone, more specifically a glucocorticoid, produced by the zona fasciculata of the adrenal gland. It is released in response to stress and a low level of blood glucocorticoids. Its primary functions are to increase blood sugar through glycogenolysis; suppress the immune system; and aid in fat, protein and carbohydrate metabolism. It also decreases bone formation. During pregnancy, increased production of cortisol between weeks 30 and 32 initiates production of fetal lung surfactant to promote maturation of the lungs. Various synthetic forms of cortisol are used to treat a variety of diseases.

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 Hydrocortisone, just click the ADD TO CART button.

HBEL

If you're wondering about HBEL, we have something for you.