Laboratory

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Aphena Pharma Solutions utilizes on-site analytical and micro laboratories as part of our full-turnkey manufacturing and packaging services. Aphena’s laboratories are GMP and FDA inspected, utilizing Laboratory Information Management Systems (LIMS), which is set up to manage all laboratory activities electronically.

Laboratory Capabilities Include:

  • Analytical Testing
  • Compatibility Testing
  • Accelerated & Real-Time Stability Testing
  • Test Method Development, Transfer, and Validation Support
  • Microbiological Testing

Analytical Methodology, Testing and/or Equipment:

  • High Performance Liquid Chromatography - HPLC’s (Normal and RP, with UV/PDA Detection)
  • Gas Chromatography - GC’s (with FID Detection)
  • Fourier-Transform Infrared Spectroscopy - FTIR
  • Total Organic Carbon - TOC
  • Ultra-Performance Liquid Chromatography - UPLC’s
  • Ultraviolet – Visible Spectroscopy – UV/Vis
  • Refractive Index - Refractometer, Karl Fischer Titration (KF)
  • Viscometers, pH Meters, Conductivity Meters
  • Liquid Chromatography/Mass Spectrometry - LC/MS
  • Inductively Coupled Plasma Emission Spectrometer - ICP/ES

Micro Laboratory – Tests to:

  • USP 61 – Microbial Enumeration Test
  • USP 62 – Specified Microorganisms
  • USP 51 – Antimicrobial Effectiveness Testing - AET (and Kill Rate Studies)