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Analytical Chemistry: Quality Control Services

Analytical chemistry is an integral component of the entire drug development process. SRI uses its years of experience and state-of-the-art technology to provide a broad range of custom and quality control analyses to our clients. We can help you identify, quantify, and characterize drug substances and products in full compliance with FDA requirements.

Our expertise includes

• Pharmaceutical analysis (reference standard characterization, active pharmaceutical ingredient, excipients)
  
  
• Analytical method development and validation
  
  
• Dose verification for GLP studies (concentration, homogeneity, stability)
  
  
• Quality control activities for cGMP clinical trial materials
  
  
• Stability studies and storage (ICH and custom conditions, photostability)

Available capabilities include chromatography (HPLC, GC), spectroscopy (FTIR, UV, NMR, ICP, FAA), electrophoresis and immunoassays (CE, SDS PAGE, Western Blot, ELISA), as well as LC/MS/MS, dissolution and disintegration testing, Karl Fischer analysis, polarimetry, wet chemistry, viscosity, and other compendial testing.

SRI's decades of experience with a wide range of drug substances and formulations in varied therapeutic areas ensure that you will get the highest quality and best value analysis available. We complement SRI's programs in formulation development, clinical trial material manufacturing, toxicology, metabolism, and pharmacokinetics.

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     Last Updated Mar 19, 2009