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Stability studies ensure that pharmaceutical products maintain their quality throughout their shelf life, influenced by environmental factors like temperature and humidity. The world is classified into climatic zones to reflect real storage conditions, with Bangladesh categorized as Zone IVa (Hot & Humid), requiring specific stability testing conditions. WHO and ICH provide guidance for stability testing, with IVb data often used by manufacturers for broader market applicability.

Author

Md. Jahangir Hossain

Language

EN