The quality of the chemical ingredients, APIs and excipients that make up a pharmaceutical product is essential to the overall success of any pharmaceutical drug. Over nearly five decades, Spectrum has developed the experience, expertise and quality systems to ensure that products always meet FDA or other quality standards in suppling pharmaceutical chemicals.
The quality of a product is only as good as the laboratory tests and scientific documentation supporting it. That's why Spectrum invests so heavily in our laboratory personnel, facilities and quality programs. Our team of more than 40 chemists, technicians and pharmacists have pharmaceutical experience with a wide range of analytical techniques, instrumentation and analyses, including the latest required USP <232/233> testing for control of elemental impurities.
Spectrum Pharmacy Products' extensive knowledge and experience in the changing global regulatory environment ensures that our products are compliant with the US FDA, DEA, ICH WHO and other worldwide regulatory entities. We perform more than 15,000 lab tests each year to help ensure safer, better pharmaceutical ingredients and better outcomes for your patients. Our investment in ICP-MS instrumentation alone for USP232/233 testing represents over one million dollars, not to mention personnel and training needed to provide these newly required tests for elemental impurities such as arsenic and other heavy metals.
Spectrum recently added over 42,000 square feet of manufacturing, laboratory, warehousing in its New Brunswick headquarters. This facility offers CFR 210/211 cGMP biopharma standard packaging capability and is ISO 8 safety rated. In January 2019, Spectrum increased to 75,000 square feet of warehousing space adjacent to the existing Los Angeles, CA facility where it is also in the process of expanding additional laboratory space.
Scientific Documentation - So Much More than a CofA
Spectrum offers over 600 professionally prepared dossiers on its USP chemicals which are all available for download. This documentation is essential for pharmaceutical manufacturers, and specific products that require special testing/certification for bioburden, elemental impurities or endotoxins. Spectrum offers more than a dozen standard tests and certifications, and can provide custom testing upon request. Providing such documentation not only on downstream production chemicals, but also on materials used during pilot and scale-up phases mitigates manufacturer’s financial and market risk by avoiding down time, or sourcing issues as a product moves through the development process.
The Right Chemicals from the Start
Spectrum works with a range of markets including manufacturers of drugs, biopharmaceuticals, cosmetics, food and beverage plus laboratory researchers. Companies in these segments are coming under increased regulatory scrutiny and must ensure that raw materials are USP/NF/FCC grade, fully tested, documented and traceable. Spectrum helps companies get the right chemicals from the start, before costly downstream production issues occur.
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.