TEMPERATURE STRESS STUDY ON THE PRODUCT GEMCITABINE, INJECTABLE SOLUTION

Abstract

Stability studies are a fundamental requirement to obtain the Sanitary Registration of a new drug. Within them, the study of temperature stress is of great importance, which provides information on the behavior of the product during storage and distribution; since the stability can be affected when a failure occurs in the cold chain. For this reason, it was established to evaluate the product Gemcitabine injectable solution through a temperature stress study. For this, the product Gemcitabine injectable solution was exposed to two extreme temperatures: two days at -20 ºC and two days at 40 ºC, repeating the cycle three times; with a total trial duration of 12 days. The fundamental physical-chemical properties of the product (organoleptic characteristics, pH, assay and organic impurities) were evaluated, with the objective of determining the affectation that it could suffer outside the storage temperature, 2-8 ºC, set for its stability, during its useful life. The results demonstrated that the sudden changes of temperature did not affect the description, the pH and the assay; but the non-specific impurities do from cycle 1. This suggested a degradation of the product. With these evidences, it was concluded that Gemcitabine solution is affected by sudden changes in temperature that could occur during the interruption of the cold chain in its storage and distribution.