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Analytical Services

Development and Validation

Our services include the development and validation of analytical methods. We identify by-products and determine polymorphic product forms. MilliporeSigma’s broad portfolio of analytical methods includes HPLC(-MS), CE, GC(-MS), FT-IR, NMR, XRD, DSC, ICP, particle size determination, and many more.

Additionally, we routinely perform microbiological tests, quantify bioburden and endotoxin contents and perform stability studies according to ICH guidelines.

  • Chemical Analytical Testing
  • Development and Validation of Analytical Methods
  • Identification of By-Products
  • Determination of Polymorphic Form
  • Stability Studies according to ICH
  • Determination of Bioburden and Endotoxin Content
  • Development and Validation of Microbiological Methods
Analytical Methods
  • HPLC (/MS)
  • CE
  • GC (/MS)
  • UV/VIS
  • FT-IR
  • NMR
  • TG
  • DSC
  • TOC
  • XRD
  • ICP
  • Karl Fischer
  • Particle Size Determination
  • Potentiometry
  • Disintegration Test on Drug Products
Microbiological Methods
  • Bioburden
  • LAL Endotoxin Test
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