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Active Pharmaceutical Ingredients
Purolite resins are used in drug formulations as Active Pharmaceutical Ingredients (APIs) or excipients. They meet the demands of the American (USP), European (Ph.Eur.), British (BP) and Japanese (JP) pharmacopoeias. Drug Master Files are held for each listed active pharmaceutical product manufactured in Purolite’s facilities.
Pharmaceutical resins used in extraction and purification processes, or for the production of water for injectables, meet the requirements of both the US Food and Drug Administration (FDA) and the European Union (EU).
In addition to their application as active pharmaceutical ingredients, excipients, ion exchange resins and polymeric adsorbents can be used in a number of pharmaceutical applications.
This includes extraction and purification of enzymes, hormones, alkaloids, viruses, antibiotics, and treatment of fermentation products.