Onyx Scientific offers specialist analytical services. We can provide you with  quality control (QC) analysis of samples using our extensive range of analytical instrumentation. We help develop and validate the analytical processes, which includes:

  • API analytical support
  • API characterisation
  • Impurity isolation and characterisation
  • Method validation, as per ICH and USP
  • Formulation analytical support
  • Pre-formulation studies
  • Solid state characterisation and polymorphic study
  • Method development
  • Stability studies, as per ICH

Below is a list of our analytical instrumentation:

  • HPLC (UV detection and ELS detection)
  • HRGC (standard injection and headspace sampling)
  • LC-MS (ion-trap)
  • FT-IR
  • UV spectroscopy
  • DSC
  • TGA & NMR
  • Raman spectroscopy
  • XRPD
  • DVS
  • Hot stage microscope
  • Karl Fischer analysis
  • Vacuum oven (loss on drying determinations)
  • Muffle oven (sulphated ash / residue on ignition)
  • Semi-prep LC

Any of these may be used in the routine QC analysis of drug substances, drug products, starting materials, raw materials and intermediates to GLP / GMP standards if required. If required, we also have additional support from our Baroda site in India.

If you would like to know more about our analytical services or any of our contract research and manufacturing services, then please get in touch today.