Sterility and Endotoxin

Therapeutic peptides are biosimilar molecules, composed of a-amino acid (AA) polymer with a defined sequence of not more than 40 AA covalently linked by amide bonds. These biosimilar molecules are crucial to various biological processes including hormone regulation, immune function, wound healing, and metabolisms.
USP 800 is a quality standard that promotes patient safety, worker safety, and environmental protection when handling hazardous drugs (HDs). It applies to all healthcare personnel who handle HDs, and all entities that store, prepare, transport, and administer HDs.