Effects of temperature excursions on mean kinetic temperature and shelf life.

The international acceptance of the definition of controlled room temperature (CRT) has given additional impetus to the use of mean kinetic temperature (MKT) as a method of quantifying temperatures during transport and storage and consequent possible effects on drug product stability. The present paper explores some of the implications of the MKT concept and considers the effect of temperature excursions on MKT values and hence on stability of drug products.