OEL Fastrac Catalog

Amylase (also known as glycogenase, endoamylase, Taka-amylase) is used in the production of predigested starchy foods and for the conversion of starch to fermentable sugars in the baking, brewing, and fermentation industries. Amylase from various sources has been used as an ingredient of preparations of mixed digestive enzymes, primarily in the form of enzymatic supplementation or as a digestive aid. It has been given by mouth for its supposed activity in reducing respiratory-tract inflammation and local swelling and edema. Alpha-amylase is also used in some detergents, especially dishwashing and starch-removing detergents. Fungal alpha-amylase extracts are primarily used as dough improvers in the preparation of bakery products. Alpha-amylase is available in combinations with other compounds as capsules and tablets for oral administration.

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 Alpha Amylase, just click the ADD TO CART button.

HBEL

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