APIs, Excipients and cGMP Polymeric Milling Media
Purolite pharmaceutical 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, single, listed 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.
In addition to their application as active pharmaceutical ingredients, excipients and water treatment media, ion exchange resins and polymeric adsorbents can be used in a number of pharmaceutical applications including extraction and purification of enzymes, hormones, alkaloids, viruses, antibiotics, and treatment of fermentation products.
PuroMill™ cGMP Polymeric Milling Media enables the preparation of high-purity nanoparticles (< 100 nm) for small molecule, high sheer applications. It is also used for biological cell disruption in biopharmaceutcal applications.
Активный Фармацевтический Ингредиент
Поглощение фармацевтических катионных веществ
Фармацевтическая измельчающая среда