L-Lysine Monohydrochloride, USP, JP, bioCERTIFIED(TM) | Spectrum Chemical®​​

L-Lysine Monohydrochloride, USP, JP, bioCERTIFIED(TM) 100% Tested.100% Transparent. 100% Tested. Spectrum Chemical bioCERTIFIED™ products are uniquely suited for bioprocessing by biopharmaceutical manufacturers. From drug discovery to pilot and scale-up to production, bioCERTIFIED™ products help simplify and standardize bioprocessing by ensuring consistent raw material quality. All bioCERTIFIED™ materials and finished goods are subject to in-house laboratory testing and analysis in cGMP-compliant facilities. This includes expanded testing for bioburden, endotoxin and elemental impurities. • Extensive product breadth and packaging flexibility for upstream and downstream bioprocessing • Expanded laboratory testing, certifications and documentation including additional lot testing for bioburden, endotoxins and elemental impurities • Comprehensive regulatory and scientific documentation to help meet global quality, regulatory and compliance requirements • Manufactured, packaged and stored under current Good Manufacturing Practices (cGMP) per 21CFR part 211 in FDA-registered and inspected facilities • Change control, lot traceability and supply chain transparency to eliminate unpredictability

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