Description
Edetate Disodium, USP, EP, JP, bioCERTIFIED (TM)
Edetate Disodium,, USP, bioCERTIFIED™ 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 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 traceability and supply chain transparency
• Auditing and quality management controls
• Extensive product breadth and Packaging flexibility
Safety Data Sheet