Spectrum Chemical Mfg. Corp has been in the chemical business for nearly five decades. We have earned the trust of quality-driven product manufacturers and laboratories by continuously reinvesting in quality systems to provide the finest ingredients and raw materials. Working with biopharma customers to improve our products and services and meet growing quality, safety and regulatory needs, Spectrum has expanded our laboratory testing with our new bioCERTIFIED^TM quality program.

• Full testing for every lot: including bioburden, endotoxin and elemental impurities

• Comprehensive regulatory & scientific documentation

• Change control & batch traceability

• 4 Analytical Testing Labs

• US Locations ISO 9001:2015

• China Laboratory ISO 17025

• Biopharm industry standard CFR 210/211 cGMP packaging facilities

The bioCERTIFIED^TM quality program covers an expanded menu of analytical tests and certifications required by biopharmaceutical manufacturers. For parenteral applications where a biological drug enters directly into the bloodstream, even more stringency is required to ensure a product is endotoxin-free with minimal bioburden. New USP 232/233 requirements for elemental impurities put even more demand on the certifications for raw materials. The new Spectrum bioCERTIFIED^TM product label identifies products that have undergone additional testing for bioburden, endotoxin and elemental impurities.

Built for Quality-Driven Industries

The quality of the chemical ingredients, APIs and excipients that make up a pharmaceutical or biological product is of primary importance to its safety and efficacy. Spectrum continues to invest in the facilities, instrumentation and regulatory compliance needed to support the needs of biomanufacturers. Learn more>>

bioCERTIFIED™ products