Analytical Services

Our analytical departments support the whole product lifecycle of drug substances and drug products with scientific competence and an extensive instrument pool. Our core competencies are:

  • Development of analytical methods
  • Optimization of existing analytical methods to improve robustness or Efficiency
  • Validation, verification and Transfer of analytical methods
  • Release Analysis of drug products, APIs, intermediates, raw materials and excipients
  • Analytics for in-process control
  • Analytics for cleaning validations
  • Evaluation of Purity Profiles/Impuritiy Tracking; Determination of genotoxic impurities
  • Risk assessments and impurity control strategy for drug substance and drug products according to ICH Q3D
  • Qualification of reference Standards
  • Development of specifications
  • Stability studies:

    • Stability studies for drug substances and drug products according to ICH requirements; performed in our own qualified stability chambers
    • Compatibility studies of binary or complex mixtures of API(s) with excipient(s) performed to Support early development phases
    • Stress test/Forces Degradation tests including photostability tests

  • Analytical project managers support the whole product life cycle

The following instruments are available in our laboratories and are fully GMP qualified:

  • Chromatography:
    • HPLC (UV, DAD, RI, CAD), UPLC, GC, GC-Headspace, Thin Layer Chromatography, Ion Chromatography
  • Spectroscopy:
    • FT-IR, NIR, UV-Vis, (q)NMR, XRPD, LC-MS, GC-MS, ICP-MS with microwave digestion
  • Particle Size Determination:
    • Malvern Mastersizer, Sympatec Helos, Air Jet Sieving, RoTAP Sieving, Microscopy
  • Wet Chemistry, Compendial Methods:
    • Titration, potentiometric Karl-Fischer Titration, coulometric Karl-Fischer Titration, Polarimetry, Polarography, DSC, Density, Refractometry, Colorimetry, Turbidimetry, Water Activity Test, standard laboratory equipment for wet chemistry
  • Specific tests for drug products:
    • Dissolution (USP/Ph.Eur. apparatus 1, 2, and 4), Tablet Hardness, Disintegration Time, Friability

     

Expect more with Siegfried as your preferred Service Partner

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Siegfried AG
Untere Bruehlstrasse 4
CH-4800 Zofingen

Phone: +41 62 746 1111
Fax: +41 62 746 1202
info@siegfried.ch