Requirements for South East Asian Markets

Part of the Biotechnology: Pharmaceutical Aspects book series (PHARMASP, volume XII)


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.


Storage Condition Drug Product Stability Study Real Time Study Conventional Dosage Form 
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  1. 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

Copyright information

© American Association of Pharmaceutical Scientists 2010

Authors and Affiliations

  1. 1.National Agency of Drug and Food Control (NADFC)Jakarta PusatRepublic of Indonesia
  2. 2.PharmalytikNewarkUSA

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