Description
Dextrose, Anhydrous, USP, EP, BP, JP, bioCERTIFIED (TM) is uniquely suited for bioprocessing by biopharmaceutical manufacturers.
100% Tested. 100% Transparent. 100% Trusted.
Whether it’s upstream bioprocessing or downstream, 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, each bioCERTIFIED™ chemical undergoes expanded testing for bioburden, endotoxin, elemental impurities and other tests required by the monographs. 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 traceability and supply chain transparency
• Extensive product breadth and Packaging flexibility
Safety and Handling Info