Requirements for South East Asian Markets
ASEAN organization is composed of ten different countries, located in the region of Southeast Asia. The environmental conditions of these countries are mostly hot and humid, which would fall in the categories of Zone IV climatic condition. This region has issued a guideline and recommended a storage condition for stability studies of 30 ± 2°C with 75 ± 5% RH.
KeywordsStorage Condition Drug Product Stability Study Real Time Study Conventional Dosage Form
- Zahn M (2008) Global Stability Practices, in Handbook of Stability Testing in Pharmaceutical Development: Regulations, Methodologies and Best Practices, Huynh-Ba, Kim (Ed.), 43–92.Google Scholar