OEL Fastrac Catalog

Please note, this OEL/ADE monograph also applies to polypropylene glycol (CAS RN 25322- 69-4). Propylene glycol is an organic solvent and diluent used as a non-toxic antifreeze in breweries and dairies, in brake fluid, as a substitute for ethylene glycol and glycerol, and in manufacturing for synthetic resins. It is also added to foods as a humectant or solvent for artificial coloring or flavoring agents and is a component of cosmetic preparations. Propylene glycol is a solvent in many pharmaceuticals including oral, injectable, or topical formulations and appears to have preservative properties. The influence of the concentration of the co-solvent propylene glycol on the preservative efficacy of a complex pharmaceutical suspension-emulsion formulation containing methyl- and propylparaben was evaluated. It was determined that the co-solvent propylene glycol was at least of equal preservative importance than both parabens.

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 Propylene Glycol, just click the ADD TO CART button.

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