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Australian Government: National Measurement InstituteAustralian Government: National Measurement Institute
National Measurement Institute
      

Pharmaceutical Analysis

range of pillsWe provide a range of services to pharmaceutical manufacturers including:

  • complete method development and validation service in accordance with good manufacturing practice
  • raw materials, finished product and stability testing in powders, tablets and oils
  • high levels of service and support
  • standard 5 working day turnaround and short turnaround time by arrangement

Testing Services

  • Trace element analysis (actives and contaminants) — ICP technology offers several benefits over older AAS methods, namely lower detection limits for most elements, wider linear range (up to six orders of magnitude) and improved batch turnaround for multi-element analysis:
    • ICP AES for analysis at ppm to assay level
    • ICP MS for analysis at ppb level
    • X-ray fluorescence for rapid elemental assay at % level
  • Pesticide analysis using GC MSMS
  • Residual solvent analysis using GC HS

Quality

Our laboratories have comprehensive quality management systems to ensure that they meet or exceed international benchmarks for good laboratory practice. Elements of our quality system include:

  • Therapeutic Goods Administration licence as a contract testing laboratory (North Ryde)
  • compliance with good manufacturing practice
  • NATA accreditation for a wide range of chemical and microbiological testing
  • regular participation in NATA proficiency testing programs
  • quality system certification (AS/NZS ISO 9001 and ISO 17025)
  • blanks, spikes, surrogates, duplicates and check samples are run with every batch
  • certified reference material which has been subject to a proficiency testing scheme and full method validation study (MX008 is available for purchase, it has certified values for Cr and information values for 14 other elements)

For further information please contact customerservice@measurement.gov.au, 1300 722 845 or use our on-line form.