bioCERTIFIED Products

bioCERTIFIED™ Products from Spectrum

The Right Materials from the Start

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 bioCERTIFIEDTM 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 bioCERTIFIEDTM 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™ 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, instrumentationand regulatory compliance needed to support the needs of biomanufacturers. Learn more>>

Example of bioCERTIFIED™ products - more coming soon!

Catalog No. Product Description Brand Size Range Grade
T9700 TRIS Base (Tromethamine) Spectrum Chemical 500 g - 20 kg USP, EP
A9600 L-Arginine Spectrum Chemical 500 g - 20 kg USP, JP
H9400 L-Histidine Spectrum Chemical 500 g – 20 Kg USP, JP
S9400 L-Serine Spectrum Chemical 500 g – 20 Kg USP, JP
T9400 L-Threonine Spectrum Chemical 500 g – 20 Kg USP, JP
V9100 L-Valine Spectrum Chemical 500 g – 20 Kg USP, JP
B8200 Benzyl Alcohol Spectrum Chemical 500 ML – 25 LT NF, BP, EP, JP, Parenteral
E9200 Ethanol 20% Spectrum Chemical 1 - 55 Gal cGMP Manufactured

 

 

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Compendial Chemicals
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Trusted Since 1971

Spectrum has been serving compounders and scientists for nearly five decades, and we've earned the trust of quality-driven industries by continually investing in our infrastructure, instrumentation, regulatory compliance and personnel. We know that our chemical products are only as good as the analytical tests and documentation prove them to be. We perform more than 15,000 analytical tests per year in our 4 globally-located analytical laboratories. Spectrum has been a privately-owned business since 1971, treating our employees and customers as part of the Spectrum family all along. Through this dedication, we have earned the trust of tens of thousands of loyal customers. Spectrum understands the cost concerns of our customers and is committed to providing the highest quality of products and the most competitive prices to our quality-driven customers.

 

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