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.
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
References
Uppala SM, Kallberg PW, Simmons AJ, Andrae U, Da Costa Bechtold V et al (2005) The ERA-40 reanalysis. Q J R Meteorol Soc 131(612):2961–3012
Visalakshi NA, Mariappan TT, Bhutani H, Singh S (2005) Behavior of moisture gain and equilibrium moisture contents (EMC) of various drug substances and correlation with compendial information on hygroscopicity and loss on drying. Pharm Dev Technol 10:489–497
WHO, Guideline for stability testing of pharmaceutical products containing well established drug substances in conventional dosage forms. WHO Technical Report Series 863, Annexure 5 (1996)
Zahn M, Kallberg PW, Slappendel GM, Smeenge HM (2006) A risk-based approach to establish stability testing conditions for tropical countries. J Pharm Sci 95(5):946–965 Erratum (2007) 96: 2177
Acknowledgment
The supply of ERA data and training in calculations by Dr Manuel Zahn are duly acknowledged.
Author information
Authors and Affiliations
Corresponding author
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 2010 American Association of Pharmaceutical Scientists
About this chapter
Cite this chapter
Singh, S., Paudel, A., Bedse, G., Thakare, R., Kumar, V. (2010). The Challenge of Diverse Climates: Adequate Stability Testing Conditions for India. In: Huynh-Ba, K. (eds) Pharmaceutical Stability Testing to Support Global Markets. Biotechnology: Pharmaceutical Aspects, vol XII. Springer, New York, NY. https://doi.org/10.1007/978-1-4419-0889-6_6
Download citation
DOI: https://doi.org/10.1007/978-1-4419-0889-6_6
Published:
Publisher Name: Springer, New York, NY
Print ISBN: 978-1-4419-0888-9
Online ISBN: 978-1-4419-0889-6
eBook Packages: Biomedical and Life SciencesBiomedical and Life Sciences (R0)