Analytical Overview

Aspira Pharma leverages a wide offering of analytical services, including method development, analytical testing and release, large scale separations and impurity identification services. We possess state-of-the-art instruments, cutting-edge technologies, and experienced scientific staff to guarantee innovative and cost-effective methodologies applied rapidly to quality determination and validation.

We adhere to the following high-level SOPs for determination of chemical purities:

  • Reference standard characterization with COA release
  • Excipient testing and release as per known USP methods
  • Confirmation of structure or absolute configuration determination by X-ray Diffractometry
  • Optical or chiral purity ascertained by chromatographic separation methods
  • Structure elucidation for impurity/degradation products by LC/MS or GC/MS as well as complementary spectroscopic validation by our 600 MHz NMR
  • Microbiological testing via microbial limit, endotoxins, DNA purity testing, water (KF), sterility testing, and EH&S

Our state-of-the-art instrumentation for chemical analysis includes:

  • NMR AVANVE III 600 MHz Bruker
  • HPLC-MS (TQ) Agilent 6410
  • HPLC-MS (TOF) Agilent 62109
  • HPLC-MS (IT) Agilent 6310
  • ICP-MS Agilent 7500a
  • HPLC Waters E2695
  • HPLC Agilent 1200
  • HPLC Agilent 1260
  • Water Purifier Milli-Q Advantage A10
  • Water Purifier Milli-Q Element A10
  • Prep HPLC VARIAN Prep Star SD 2
  • GC Agilent7890A
  • Elemental Analyzer (Electronic Balances) Vario Micro Cube
  • X-ray Diffraction D2 PHASER Bruker
  • Ion Chromatography ICS-90
  • FTIR, Spectrum 100 Spotlight 200 Perkin Elmer
  • UV UV-2550 Shimadzu
  • Fluorescent / Phosphorescent / Luminescent Spectrophotometer, Cary Eclipse Varian
  • Lyophilizer (4L) Coolsafe 55-4 System SCANLAF

For more information about our leading chemistry services, please contact