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Stability testing for prescription medicines

6 March 2017

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14.1 What medicines require stability testing

This guidance applies mainly to:

  • prescription medicines containing active substances prepared by chemical synthesis
  • prescription medicines containing active substances that are pure chemical entities isolated from a natural source (e.g. vincristine, digoxin)
  • prescription medicines containing active substances produced by microbial fermentation (e.g. many antibiotics and some anticancer agents)
  • radiopharmaceuticals
  • biotechnological medicines
  • biological medicines.

Note about Radionuclide generators

This guidance does not cover radionuclide generators.

Information required on the stability of radionuclide generators varies with each case. Advice on requirements for a particular generator system may be obtained from Australian Radiation Protection and Nuclear Safety Agency (ARPANSA).

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