ECHA | Cytiva Sweden AB Opinion Adopted for 4-nonylphenol, ethoxylated

Broad information on use applied for: 4-Nonylphenol, branched and linear, ethoxylated (NPE) is present as a critical process agent in four different emulsifiers used in the manufacturing of intermediate resins for the further production of more than 120 chromatography resins. The use takes place at one site in Sweden. The chromatography resins produced by the applicant are used in biopharmaceutical applications for the manufacture and purification of active pharmaceutical ingredients (APIs) and for research and development activities, in analytical applications for the characterization and development of analytical methods for biomolecules and polymers, in the food and beverages industry (e.g. to detect food additives), and in nutraceuticals and nutritional chemistry.

During the production of intermediate resins, NPE-containing emulsifiers are added in the emulsification step to aid in the formation of aqueous droplets dispersed in a solvent phase. A subsequent reduction of temperature triggers solidification of the droplets and thereby formation of porous polysaccharide-based particles. A series of washing steps follows to remove all residuals of emulsifiers and solvents from the particles. The washed particles correspond to the intermediate resin product, which is then further used for down-stream processing. The size, shape and physical properties of these particles determine the characteristics of the different chromatography end-products.



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