Analytical Services

AAIPharma Services analysts are trained on numerous routine and specialized techniques. Let us support your NDA, ANDA, and IND submissions:

  • HPLC and GC Analyses
  • Dissolution Studies
  • Mass Spectroscopy
  • Physical and Wet Chemical Analysis
  • Residual Solvents
  • Solvent Analyses
  • Stability Storage and Testing
  • Method Development and Validation
  • Process and Cleaning Validations
  • Thermal Analysis
  • Total Organic Carbon (TOC)
  • Container/Packaging Testing
  • Antibiotic Assays

Instrumentation

HPLC

UV/Visible, diode-array, fluorometric, conductivity and refractive index detection

GC

Flame ionization, and thermal conductivity detection. Capillary and headspace techniques.

MS

Sciex API 5000 mass spectrometer.

IC

Dionex ICS-3000 ion chromatograph with conductivity, amperometry, and UV/PDA detectors.

Dissolution

USP Methods I and II with automated sampling and quantitation.

Spectroscopy

Atomic Absorption, UV/Visible, Infrared (FTIR and ATR), and fluorometric

Analytical Chemistry links to: Primary Methods Performed; Samples Analyzed; Facilities & Equipment; Method Validation