This monograph applies to casein and its salt or hydrolyzed forms, as follows casein (CAS RN 9000-71-9), sodium caseinate (CAS RN 9005-46-3), casein, potassium salt (CAS RN 68131-54-4), casein, calcium complexes (CAS RN 9005-43-0), ammonium caseinate (CAS RN 9005-42-9), and casein hydrolysate (CAS RN 65072-00-6). Although often referred to as a single protein, casein is a mixture of phosphoproteins occurring in milk and its derivatives. At least 20 casein components have been found by electrophoretic analysis of samples of pooled cow milk. Casein corresponds to approximately 79% of all milk proteins. The main fractions, designated α-casein, β-casein, and κ-casein, are known to be mixtures rather than single proteins. Moreover, genetic polymorphs have been found for each major component. Casein is comprised of 18 amino acids including all those essential in human nutrition. The nitrogen content is about 15.6%, phosphorus about 0.9%, and sulfur about 0.6%. Casein may be classified as having intermediate biological value (72% compared to whole egg protein as a standard).
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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