Spectrum Chemical L-Glutamine,cGMP

Spectrum Chemical L-Glutamine, cGMP, bioCERTIFIED (TM)L-Glutamine, cGMP, 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 - SPCM (Additional S&H or Hazmat Fees May Apply)