QC Services >> Chemistry Services >> Impurities Testing for Pharmaceutical Products and APIs

Impurities Testing for Pharmaceutical Products and APIs

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We have extensive experience in impurities testing:

Process Impurities / Degradants

  • Qualitative/quantitative analysis
  • Customized method development / validation
  • Tracking and trend investigation for stability studies

Residual Solvents / Impurities (ICH Q3C)

  • USP<467>, JP<2.46>, EP<2.4.24> (all classes of residual solvents in current chapters)
  • Customized method development / validation
  • Available for headspace injection

Trace Metals (ICH Q3D)

  • Qualitative / quantitative limits testing using ICP-AES and ICP-MS approaches
  • Customized method development / validation

Elemental Analysis

  • Quantitative testing of limits using CHN elemental analysis system and ion chromatogram (F, Cl, Br, S) approaches

Instrumentation

Mass Spectrometers

  • GC/MS
  • LC/MS
  • LC/MS-IT-TOF
  • ICP/MS

Chromatography Equipment

  • GCs with either headspace or direct injection
  • HPLCs and UHPLCs
  • ICS-3000 and ICS-5000 Ion Chromatographs

HPLC Detectors

  • Ultraviolet-visible (UV)
  • Refractive Index (RI)
  • Diode Array (DAD)
  • Corona Charged Aerosol (CAD)

Spectrophotometers

  • Ultraviolet-visible Spectrometer (UV-VIS)
  • Fourier Transform Infrared Spectrometer (FT-IR)