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-MS VARIAN GC MS 320
GC Agilent7890A
Elemental Analyzer (Electronic Balances) Vario Micro Cube
X-ray Diffraction D2 PHASER Bruker
Ion Chromatography ICS-90
AA VARIAN AA 240 DUO
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 collaborate@aspirasci.com.