OEL Fastrac Catalog

Please note, this OEL/ADE monograph also applies to levothyroxine sodium (CAS RN 55-03-8), Levothyroxine sodium monohydrate (CAS RN 25416-65- 3), Levothyroxine sodium pentahydrate (CAS RN 6106-07-6). Levothyroxine (also known as L-thyroxine) is a synthetically produced form of thyroxine (T4), a major endogenous hormone secreted by the thyroid gland. Levothyroxine is indicated as replacement therapy in primary (thyroidal), secondary (pituitary) and tertiary (hypothalamic) congenital or acquired hypothyroidism. It is also indicated as an adjunct to surgery and radioiodine therapy in the management of thyrotropindependent well-differentiated thyroid cancer. Levothyroxine is also indicated for prophylaxis against goiter recurrence following resection of euthyroid goiter and for benign euthyroid goiter, for thyroid suppression test, for postthyroidectomy due to thyroid malignancy, and in thyroid suppression scintigraphy. In veterinary medicine, the claimed indications for levothyroxine, in combination with 3,5-diiodo-L-thyrosin, are activation of metabolism and digestion. It is used in the treatment of insufficient milk excretion, loss of weight, chronic indigestion, and convalescence in cattle in pigs. It can also be used in other species.

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 Levothyroxine, just click the ADD TO CART button.

HBEL

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