查看文章

The ICHQ1A standards of the European Pharmacopoeia contain data on the quality of drugs and various pharmaceutical forms [1, 2]. The stability of the pharmaceutical forms in time, the maintenance of the product quality from the preparation until the moment of use represents a fundamental requirement for obtaining the expected therapeutic effect [3]. According to the European Pharmacopoeia, the study of the stability of the active substances in various pharmaceutical forms is a key step to establish the validity of the pharmaceutical product [4].

At an international level, a guide was elaborated for stability studies, and the tests were chosen depending on the climatic conditions in each area, establishing the conditions for those studies, both in determining the active substance and in determining the finished product, as follows: for long-term study (minimum 12 months) at 25±2 o C and relative humidity 60±5% and short-term study (6 months) at 40±2 oC and relative humidity 75±5%[4]. The purpose of the stability test is to provide evidence of the quality of a substance in a particular pharmaceutical form and how its quality varies under the influence of environmental factors such as temperature, humidity and light. The data of the stability study must confirm that the pharmaceutical product continues to meet its specifications throughout validity in the region in which it is registered. Stress testing is performed to evaluate the drug under high temperature and humidity conditions. The data obtained are useful for understanding the stability profile of the drug during manufacture, storage and transport. These studies provide an insight into the degradation …