All
suppliers say they have quality. At Spectrum, we prove
it every day.
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
ensure safer, better pharmaceutical ingredients and better
outcomes for your patients.
Does your pharmacy compounding supplier offer all
this?
40+ in-house chemists with
expertise in:
Instrumental
Atomic Absorption Fourier
Transform Infrared Spectroscopy Fluorescence
Gas Chromatography HPLC/UHPLC
ICP/MS Karl Fischer Titration
Melting Point Potentiometric Measurements
(pH and ISE) More: Proteomic Imaging,
Refractive Index, Rotational Viscosity, Specific and
Optical Rotation, UV/Vis Spectroscopy
Wet Analysis
Colorimetric Analysis
Gravimetric Analysis Solvent Extraction
Techniques Titrimetry (Acidimetric,
Complexometric and Redox)
Microbial Testing
Differentiate Bacterial Colonies
DNase RNase
Protease Endotoxin by LAL
Total Plate Count Yeast and Mold
Bicoastal cGMP US testing laboratories
West Coast Facilities
Manufacturing, Distribution, Sales and
Administration 14422 South San Pedro Street
Gardena, CA
Corporate Headquarters
Manufacturing and Distribution 777 Jersey
Avenue New Brunswick, NJ
Tom Tyner, Vice President of Quality
Assurance/Quality Control
- 2017-2018 Chair of the ACS Committee on Analytical Reagents
- Spectrum team member for over 30 years
- Dedicated to continuous improvement of the quality
system at every level throughout the company
Continuing education programs*
More than 1,200 monograph chemical items**
More than 700 USP bulk items**
FDA registered facilities operating
under current Good Manufacturing Practices (cGMP)
California and New Jersey in-house
analytical laboratories operating under current Good
Laboratory Practices (cGLP)
Facilities certified to the current
ISO 9001:2015 quality standard
DEA registration as a manufacturer
of Controlled Substances (Schedules II - V)
Regular manufacturer site audits to
ensure batch-to-batch consistency
Active support of Rx-360, an
international pharmaceutical supply chain consortium,
and support of
transparency in the supply chain
* All education programs are ACPE accredited through the
Ernest Mario School of Pharmacy/Rutgers University or the
American College of Apothecaries.
**All of Spectrum's USP/NF/FCC grade monograph compounding
chemicals are manufactured, handled, packed and held under
current Good Manufacturing Practices (cGMP) per 21CFR parts
210 and 211 in FDA inspected facilities.
|