Shelf-life Stability Evaluation of Dehydrated TROFIN®

Abstract

Introduction: Iron deficiency anemia is the most widespread nutritional deficiency in Cuba. In order to reduce the functional impact of this deficiency, the National Center of Biopreparations is evaluating dehydrated TROFIN®, an active pharmaceutical ingredient to be used in the production of anti-anemia drugs.

Objective: To determine the chemical, physical and microbiological quality and stability of dehydrated TROFIN®, active pharmaceutical ingredient.

Methods: A shelf-life stability study was carried out on lots 8P08AI, 8P09AI and 8P09BI. For this purpose, the samples of the active pharmaceutical ingredient were packed in double low density polyethylene bags which were placed inside cylindrical cardboard containers with plastic lid and adjustable metal closure to protect it from the effect of moisture and light. The container with the bags was placed in an air-conditioned room whose temperature was 15 to 25 °C and residual humidity ≤ 70 %. Physicochemical parameters were evaluated at times 0, 1, 2, 2, 3, and 6 months and microbiological tests were performed at times 0 and 6 months.

Results: All three batches performed within the acceptance limits of all quality parameters established for the active pharmaceutical ingredient during the six months. In addition, trend analysis of quantitative parameters showed that the product could be stable up to 10 months.

Conclusions: The work demonstrated that the dehydrated TROFIN® active pharmaceutical ingredient is stable up to six months under the specified packaging and environmental conditions and therefore can be employed in the production of drugs for iron deficiency anemia.