Analytical services for surfactant quantifiation and characterization
Surfactants stabilize biomolecules against interfacial stress and/or are prevent adsorption. Polysorbate 20 and 80 (also known as Tween®) and poloxamer 188 (e.g., Kolliphor®) are so far the only FDA-approved surfactants for parenteral application.
Besides their benefits, it is common knowledge that surfactants, such as polysorbates, are prone to undergo degradation by hydrolysis and oxidation. While such degradation can directly affect the function of the surfactant, it could also lead to the formation of insoluble fatty acid-related particles over time. A potential issue for the safety and efficacy of a biopharmaceutical drug product.
The quality requirements for pharmaceutical grade polysorbate 20 and 80 are specified in the different pharmacopoeias. Further, the ICH countries agree on the key requirements, such as impurity levels and fatty acid composition. For polysorbate 80, the Chinese Pharmacopoeia describes the strictest regulations for the fatty acid composition and requests an all-oleate polysorbate (≥ 98%), whereas the European and US pharmacopoeias specify a purity of ≥ 58% for oleic acid.