Tris(hydroxymethyl)aminomethane, USP, EP, BP, bioCERTIFIED (TM), 2.5 kg is bioCERTIFIED™ for bioprocessing by biopharmaceutical manufacturers, 503B compounding pharmacies, outsourcing facilities and other industries. Tris is suggested to use as a buffer and enzyme inhibitor in biopharmaceutical manufacturing.
Tromethamine USP, EP, BP, bioCERTIFIED™ products are manufactured, packaged and stored under current Good Manufacturing Practices (cGMP) per 21CFR part 211 in FDA registered and inspected facilities.
Spectrum Chemical’s bioCERTIFIED™ quality management program goes beyond standard testing and includes APIs, excipients and many more chemicals that carry additional certifications and documentation specifically designed to meet the needs of biopharmaceutical businesses including manufacturers and pharmacies. Each bioCERTIFIED™ chemical undergoes expanded testing for bioburden, endotoxin, elemental impurities and other tests required by the monographs and processed under the ISO class 8 certified facility.