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.
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:
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