TESTING & STABILITY STUDIES

The TGA requires that complementary medicines are of acceptable quality throughout their shelf life. In order to prove this, ongoing testing of the product and comparison with specifications must be conducted throughout the shelf life. Each unique product formulation requires stability testing.

We provide stability studies testing according to TGA & ICH guidelines in a new state of art laboratory-NATURALAB PTY. LTD – licensed by the Australian Therapeutic Goods Administration (TGA) for herbal and chemical testing.

ANALYTICAL EQUIPMENT

  • HPLC with UV and ELSD detector
  • HPLC with PDA detector
  • GC with flame ionisation detector
  • Fourier transform IR spectrometer
  • Auto titration system
  • High performance TLC system with video capture system
  • Karl Fisher System
  • Bio Lumix - automated solution for microbiological testing
  • Stability chambers under climatic conditions complying with ICH guidelines
  • Storage specific conditions on request
  • Permanent computer-controlled and recorded conditions

Particular expertise

  • Development & problem solving of analytical methods
  • Validation of testing methods
  • Identification and assay of herbal raw materials
  • Stability studies on any pharmaceutical formulations
  • Accelerated and long term stability studies

THE TEAM

Our highly qualified team has many years of global & local experience in the demanding science of herbal testing and testing for individual ingredients in the presence of many other ingredients.