OEL Fastrac Catalog

Please note, this OEL/ADE monograph also applies to sitagliptin phosphate (CAS RN 654671-78-0), sitagliiptin phosphate monohydrate (CAS RN 654671-77-9), sitagliptin hydrochloride (CAS RN 486459-71-6), sitagliptin malate (CAS RN 1240039-02-4), sitagliptin sulphate (CAS RN 1169707-31-6), and the alternate salt (CAS RN 862156-92-1). Sitagliptin is an oral dipeptidyl peptidase-4 (DPP-4) inhibitor used in conjunction with diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus. Sitagliptin phosphate is used in conjunction with diet and exercise to control blood glucose concentration in adults with type II diabetes. Sitagliptin phosphate is thought to act by prolonging increased incretin levels which indirectly improves glucose level stability and lowers elevated blood glucose concentrations.

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 Sitagliptin, just click the ADD TO CART button.

HBEL

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