EVALUATION OF THE INFLUENCE OF STORAGE TIME BETWEEN PROCESSING STEPS ON THE STABILITY OF THE ACICLOVIR 400MG COMPRESSED PRODUCT

Abstract

Stability is defined as the conservation of the properties and characteristics of a product within the given specifications. The evaluation period considers the moment from its production to the end of the stipulated shelf life, throughout its storage and use, being an indispensable parameter to analyze the quality, safety and efficacy of a drug. To evaluate the stability of an insum or product, tests are performed using extrinsic and intrinsic factors that allow to ponder the maintenance of its physical, chemical, microbiological and therapeutic characteristics. In addition, studies are conducted capable of determining degradation products from active pharmaceutical input (IFA) and excipients, the shelf life of the product and the ideal conditions of packaging and storage, certifying the permanence of its originals characteristics. Waiting time studies are extremely important as they allow greater flexibility for the company and its production, ensuring the quality of intermediate and bulk pharmaceutical products, under the normal storage conditions, for a certain period. The results obtained in the stability comparison of two batches of the product Aciclovir 400mg compressed, show that the storage time between the productive stages does not interfere in the physical, chemical, biological, and microbiological characteristics of the pharmaceutical product.