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Serving Compounders Since 1971

Corner

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.