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The Challenge of Diverse Climates: Adequate Stability Testing Conditions for India

  • Saranjit SinghEmail author
  • Amrit Paudel
  • Gaurav Bedse
  • Rhishikesh Thakare
  • Vijay Kumar
Chapter
Part of the Biotechnology: Pharmaceutical Aspects book series (PHARMASP, volume XII)

Abstract

India has diverse climatic conditions across the country, which is the reason for interest in its long-term stability testing conditions that are not yet defined. The same were calculated using the risk-based approach proposed recently in the literature. In total, 18 cities were selected through length and breadth of the country, and mean kinetic temperature and average relative humidity were determined for each. The extreme climate was found in the city of Trivandrum in the southern state of Kerala, which has equatorial monsoonal conditions for almost 7 months in a year. The long-term stability testing condition for the place calculated out to be 30°C/70% RH. The same was considered to represent whole of the country, which being the worst case. Although this storage condition was originally suggested for zone IV, it is not included in current WHO classification of long-term stability testing conditions for various zones. This article describes a revised classification proposed to accommodate India and even other countries with hot and moderately humid climate.

Keywords

Storage Condition Humid Climate Thar Desert Partial Water Vapour Pressure Diverse Climate 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

Notes

Acknowledgment

The supply of ERA data and training in calculations by Dr Manuel Zahn are duly acknowledged.

References

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Copyright information

© American Association of Pharmaceutical Scientists 2010

Authors and Affiliations

  • Saranjit Singh
    • 1
    Email author
  • Amrit Paudel
    • 1
  • Gaurav Bedse
    • 1
  • Rhishikesh Thakare
    • 1
  • Vijay Kumar
    • 1
  1. 1.National Institute of Pharmaceutical Education and ResearchNagarIndia

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