Chlorobutanol, Anhydrous, NF, bioCERTIFIED(TM)

Chlorobutanol, Anhydrous, NF, bioCERTIFIED(TM). Spectrum Chemical graded products (USP/NF, EP, BP, JP, FCC) are handled, packaged, labeled, stored, and tested in FDA registered and inspected facilities. All operations are conducted in compliance with current Good Manufacturing Practices (cGMP) as defined in 21 CFR Parts 210 and 211. Furthermore, the original manufacturers of these materials adhere to appropriate GMP standards, such as ICH Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients or FDA 21 CFR Parts 210 and 211, ensuring the highest quality and regulatory compliance throughout the supply chain. bioCERTIFIED™ products are manufactured, packaged and stored under current Good Manufacturing Practices (cGMP) per 21CFR part 211 in FDA registered and inspected facilities. Spectrum Chemical's bioCERTIFIED™ quality management program goes beyond standard testing and includes APIs, excipients and many more chemicals that carry additional certifications and documentation specifically designed to meet the needs of biopharmaceutical businesses including manufacturers and pharmacies. Each bioCERTIFIED™ chemical undergoes expanded testing for bioburden, endotoxin, elemental impurities and other tests required by the monographs.