Analytical Capabilities

Real-world Analytics, state of the art technology

We inherently appreciate that developing robust analytical methods is a fundamental element of bringing a new drug substance to market. This capability is driven by dedicated analytical chemists with real-world, actionable experience using state-of-the-art technology.

With over 30 years of experience in API development and an in-house comprehensive range of analytical capabilities, we can support our customers with their projects at any stage throughout all clinical phases and into commercial production.

Analytical Technical Capabilities

  • Characterization
  • Absolute Configuration
  • Polymorphism
  • Particle Sizing
  • Compatibility
  • Impurity Profiling
  • Solid-State Characterization – DS

Quality Control

  • Product-specific analytical methods are established for process control, product release, and intermediate/raw material releases
  • Impurity tracking
  • Reference standard characterization
  • Specification development,
  • Method transfer and validation
  • Stability studies performed according to ICH guidelines
  • Force degradation studies

A Wide Range of Analytical Equipment

Dishman Carbogen Amcis Ltd has a wide range of analytical equipment available across all sites and available for our use. 

Chromatography

  • HPLC (DAD, UV, RI)
  • Ion chromatography
  • HPLC-MS
  • GC (FID, NPD)
  • GC (Headspace) 
  • GC-MS
  • TLC with scanner

Spectroscopy

  • NMR 400 MHz
  • FTIR
  • ICP-MS
  • CHN
  • XRD
  • UV-Spectrophotometers
  • Polarimetry ok

Physical

  • Malvern particle sizer
  • Microscopy
  • DSC
  • Autotitrators

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