Drug product analytical development & validation

You can count on our team to provide you with the highest quality analytical support. Whether your analytical requirements are big or small, let our drug product expertise meet your needs.

We are equipped to handle stability programs at all ICH conditions including stability testing of controlled substances. Cambrex can perform phase appropriate analytical validation for Phase I clinical drug products up to Phase III and commercial.  Our analytical experts can develop methods for assay, impurities or related substances and dissolution for IR and MR products.

Our drug product analytical services equipment includes:

  • Gas chromatography (GC) [Agilent with FID, TCD detection]
  • High pressure liquid chromatography (HPLC) [Waters and Agilent] with UV/Vis, PDA, ELSD detection
  • Ultra-High Pressure Liquid Chromatography (Waters) with UV/VIS, PDA and ELSD detection
  • Viscosity testing and measurement
  • Particle size analysis [Malvern, Ro-tap, Air-Jet Sieve]
  • Moisture analysis: Karl Fischer and Colorimetric Titrations
  • Dissolution USP Apparatus I and II (Distek, Vankel and Sotax dissolution units) along with Autosampler Agilent 8000 and Sotax AT70
  • FTIR (Perkin Elmer)
  • FT-NIR (Thermo Nicolet Antaris)
  • UV Spectrometry (Agilent)
  • Atomic absorption spectrometry
  • Water activity tester (Aqua lab)
  • Fluorescence spectrophotometer
  • Osmometer
  • Viscosity (Brookfield)
  • Densimeter (Precision & Anton Paar)
  • Penetrometer (Precision)
  • Polarimeter (Perkin Elmer)
  • Conductivity Tester (Swan and Horiba)
  • Photostability Chamber (Atlas)

Analytical techniques

  • Forced degradation (stress) for the detection of impurities or degradation products
  • Method development and validation of test methods for drug substances and drug product
  • Analytical method transfers
  • Development and validation of analytical cleaning analyses and studies
  • Process validation characterization
  • Residual solvents as USP <467>
  • Qualitative and quantitative analysis
  • Wet chemistry

Stability storage capabilities

ICH stability storage is available at the following temperatures and humidity:

TemperatureHumidity
-20°C
5°CAmbient
25°C60%RH
30°C65%RH
30°C75%RH
25°CAmbient
40°C75%RH

Cambrex offers a wide range of ICH stability storage services including stability storage of controlled substances:

  • All chambers are kept physically locked
  • Audible and visual alarms for temperature and humidity
  • Back-up generator UPS on data logger ensuring continuous monitoring and alarm call outs
  • Facility monitored by access control

Don’t hesitate to get in touch if you require more information about our drug product analytical development and validation services. Our experts are always available to help.

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