Behavior of Uptake of Moisture by Drugs and Excipients under Accelerated Conditions of Temperature a

One of the major changes brought about by the introduction of the International Conference on Harmonization (ICH) guidelines for stability testing of pharmaceutical products has been to standardize temperature and humidity testing conditions (1). Although the environment typically consists of temperature, humidity, and light, the ICH still preferred to develop a separate photostability testing guideline because products in ICH member countries are sold in secondary packages, which eliminates the necessity for light testing along with temperature and humidity (2). Although light isn’t considered a main testing factor in several ICH member regions (e.g.,United States, Europe, and Japan), it is an important factor with respect to the sale of products in several countries outside the ICH’s influence.Many tropical countries have adverse environmental conditions, including high temperature, humidity, and intense light. Products are usually sold without secondary packages in shops that don’t have air conditioning. Pharmaceutical manufacturers in ICH member countries are now shifting their focus toward global marketing as the incomes of individuals are rising in various parts of the
world.With this shift in focus, global storage-testing conditions have come into intense discussion (3–6). Hence the question arises: Should pharmaceutical products marketed in tropical countries be tested for stability using the combination of temperature, humidity, and light?

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