To ensure the quality of the applied drug, stability testing is required to estimate its shelf life. Simultaneously refer to the coordination meeting
（International Conference on Harmonization of Technical Requirements for Registration of
The guidelines for Pharmaceutical for Human Use (ICH) have been revised and replaced by the Drug Administration's Notice No. 87.7.22
87041838 "Drug Stability Test Standards".
This standard applies to the following types of drugs:
(1) New drugs (new ingredients, new routes of use, and new therapeutic effects of compound drugs 2)
(2) New dosage form 3, new dosage and generic drug.
This benchmark includes accelerated test 4 and long-term test 5.
This standard is a general provision for stability testing. If there is a discrepancy between the submitted data and this standard, the manufacturer must provide a scientific explanation
Based on and supporting various materials for its changes. In consultation with the competent authority, manufacturers may also adopt alternative testing methods.
Purpose: Stability test is to investigate the relationship between drug quality and changes over time due to environmental factors such as temperature, humidity, and light
Develop a drug degradation curve to estimate the effective period and ensure the efficacy and safety of the drug during use.