OEL Fastrac Catalog

Catalase is an antioxidant enzyme obtained from many biological sources including animal liver (hepatocatalase) and certain bacteria and fungi. It has been applied to wounds and skin ulcers and has also been used in the treatment of vitiligo. It has sometimes been included in preparations for contact lens care to neutralize H2O2. Catalase has various industrial applications. In the food industry, it is used in combination with other enzymes in the preservation of foodstuffs and in the manufacture of beverages and certain food items. Commercial catalases are also used to break down H2O2 in wastewater. Catalase can be used as a dietary supplement indicated for endogenous antioxidant support. It aids in protecting cells against oxidative stress. Catalase contributes to the maintenance of redox homeostasis, acting on mitochondria and peroxisomes. Catalase can be used as an adjuvant in protocols and formulations aimed at aging and conditions associated with oxidative stress (indirect use). Catalase aids in the antioxidant protection of the hair follicle, contributing to the reduction of oxidative stress associated with the progressive loss of hair pigmentation, and it contributes to the maintenance of a physiologically balanced follicular environment, promoting the integrity of the structures involved in hair growth.

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 Catalase, just click the ADD TO CART button.

HBEL

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