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Abstract

In stability testing, the mean kinetic temperature (MKT) and relative humidity (RH) are two important factors which have an impact on the determination of the shelf-life of a drug product. This report presents the MKT and RH of Taiwan based on climate data from different areas of Taiwan between the years of 1991 and 1995. The data used in the calculation is from the Central Weather Bureau of Taiwan. Activation energies of 10 to 30 Kcal/mol are considered. The results show that the MKT of Taiwan is 24.5°C given a typical activation energy of 20 Kcal/mol, and the RH is 77%. Drug products degrade faster under higher MKT and RH. Based on analogous safety margins for MKT and RH in climatic zones I (19.7°C/43.9%, MKT/RH) and II (22.8°C/52.9%) as specified in the international conference on harmonization (ICH) stability testing guideline, the long-term storage test conditions for Taiwan would be 28 ± 2°C and 90 ± 5% for temperature and humidity, respectively. These derived storage conditions are in fact 3°C and 17% higher than those in the ICH guideline specified for the tripartite countries (EC, Japan and USA). For a 3°C increment in MKT, the degradation rate constant will actually increase by about 34%. In consequence, a product marketed in Taiwan will only have about 75% of the shelf-life that it would have in the tripartite countries. In this communication, the implications of the climatic conditions of Taiwan are examined. Appropriate storage test conditions for drugs and products stability testing in Taiwan are also proposed.

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