Analytical Development

Meeting the demanding specifications and regulatory requirements for pharmaceuticals requires an analytical testing and method development program that combines a high level of chemistry knowledge with practical expertise. Plus, it should be easy — and comfortable — to interface with the scientists working on your project.

At 国家授权正规彩票平台, our drug product analytical development specialists are experts you’ll enjoy working with. They will embrace your analytical development and validation challenges and work diligently to find efficient solutions.

Our specialists can perform phase-appropriate analytical validation for Phase I clinical drug products up to Phase III and commercial. They will ensure that you receive robust, transferable, stability-indicating methods that are tailored to your phase of development and comply with ICH guidelines.

Analytical Services

Our drug product analytical services include:

  • Method development, optimization, and validation
  • Microbiology testing and USP qualification
  • Residual solvent method development/validation
  • Elemental impurities testing
  • ICH stability testing and storage, including stability testing of controlled substances
  • Warehousing of drug substances and finished products
  • Forced degradation (stress) for the detection of impurities or degradation products
  • Analytical method transfers
  • Development and validation of analytical cleaning analyses and studies
  • Process validation characterization
  • Qualitative and quantitative analysis

Analytical Services Equipment

Our drug product analytical services equipment includes:

  • Gas chromatography (GC) [Agilent with FID and TCD detection]
  • High pressure liquid chromatography (HPLC) [Waters and Agilent] with UV/Vis, PDA, and 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, and 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 and Anton Paar)
  • Penetrometer (Precision)
  • Polarimeter (Perkin Elmer)
  • Conductivity tester (Swan and Horiba)
  • Photostability chamber (Atlas)

 

Discover a different CDMO

Looking for a partner that balances passion with painstaking attention to detail? Speak to one of our experts about our drug product analytical development and validation services.

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