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Analytical Development

Siegfried understands the critical importance of requisite analytical parameters and controls for effective and robust formulations. Our well-experienced Drug Product Analytical Development team works closely with their Pharmaceutical Development counterparts to ensure our customer’s product is fully supported at every phase in the development process. Modernly equipped, we provide the following range of analytical services to help bring your drug product development project & cGMP manufacture to fruition:  

  • Active ingredient characterization and preparation of specifications (e.g. intrinsic dissolution, particle size, polymorphic form, NMR, IR, HPLC-MC, etc.) in close collaboration with the Drug Substance Analytical Development Department
  • Development of analytical methods and specification preparation for the finished medicinal product (e.g. content, purity, chiral purity)
  • Development of discriminating dissolution methods (e.g. different pH values, surfactants, etc.)
  • Stability screening (including forced degradation and photostability investigations) for the selection of the final formulation and primary packaging material
  • Validation and transfer of analysis methods (including documentation in English)
  • Release analysis of clinical trial material and of registration batches, in compliance with cGMP
  • Planning, transformation and documentation of stability studies under ICH conditions in qualified and controlled climate chambers
  • Support, adaptation and optimization of customers’ methods. Qualified analytical instruments and climate chambers with online monitoring
  • Analysis of highly-active substances and formulations (cGMP-compliant)

 Instruments and equipment for analytical investigations

  • HPLC Systems (UV / DAD, Agilent, Waters)
  • DryLab Software for computer-supported HPLC method development
  • GC System (Agilent)
  • Dissolution systems for manual sampling (Sotax, Distec)
  • Dissolution systems for online measurements (UV-VIS, Sotax, Agilent)
  • Dissolution systems with automated sampling (Sotax, Pharmatest)
  • Degasser, heater, filler and dispenser instruments for dissolution media (DosaPrep)
  • UV-VIS spectrophotometer (Agilent)
  • Tablet hardness tester  (Erweka)
  • Dissolution tester (Erweka)
  • K.F. titration
  • Particle size analysis (Malvern)
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