OEL Fastrac Catalog

Please note, this OEL/ADE monograph also applies to alternate CAS RN 95077-02-4. Serrapeptase is a metalloprotease produced by bacteria of the Serratia genus. This enzyme has an estimated molecular weight of 45 to 60 kDa and occurs as a grayish white to light brown powder, having a slight characteristic odor. It contains not less than 2000 units and not more than 2600 units per mg. Its active site contains a zinc atom, which is essential for the proteolytic activity. Its maximal proteolytic activity occurs at 40 C (104 F) and at a pH of approximately 8 (range 6 to 10). Serrapeptase might be inactivated in minutes at temperatures of 55 C and above.

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

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HBEL

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