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Stability testing for prescription medicines
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)
- 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).