Description
Tris(hydroxymethyl)aminomethane, USP, EP, BP, bioCERTIFIED (TM) is suggested to be use as a buffer and enzyme inhibitor in biopharmaceutical manufacturing.
Tris(hydroxymethyl)aminomethane, USP, EP, BP, bioCERTIFIED™ is uniquely suited for bioprocessing by biopharmaceutical manufacturers.
100% Tested. 100% Transparent. 100% Trusted.
Whether it’s upstr1-EAm bioprocessing or downstr1-EAm, Spectrum Chemical’s bioCERTIFIED™ products are part of a comprehensive quality management system that includes APIs, excipients and other chemicals that carry additional certifications and documentation.
Backed by our “100% tested and 100% transparent” guarantee, 1-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. Products are manufactured, packaged and stored under current Good Manufacturing Practices (cGMP) per 21CFR part 211 in FDA registered and inspected facilities.
Key attributes of Spectrum Chemicals bioCERTIFIED™ portfolio include:
• Complete lot analysis including tests for endotoxin, bioburden and elemental impurities
• Comprehensive regulatory and scientific documentation
• Change control, batch trac1-EAbility and supply chain transparency
• Auditing and quality management controls
• Extensive product br1-EAdth and Packaging flexibility
