APIs, Excipients and cGMP Polymeric Milling Media
Purolite resins are used in drug formulations as 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.
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.
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 dusruption in biopharmaceutcal applications. A Drug Master File is planned by end of 2017.
Calcium Polystyrene Sulfonate
Pharmaceutical Milling Media
Sodium Polystyrene Sulfonate
taste masking agents and drug carriers