Chemical Stability of Hydrocortisone in Topical Preparation in Proprietary VersaPro™ Cream Base

Abstract

The United States Pharmacopeia-National Formulary (USP-NF) suggests beyond use dating ((BUD) for compounded topical preparations containing active pharmaceutical ingredients (API) [1]. The beyond the use dates of the preparations are based on the conservative and empirical guidelines of USP 795. Hydrocortisone (HC) content compounded in the VersaPro™ base cream was quantified using a HPLC method at time zero and after 30 and 60 days of storage at both room temperature and 4°C. The analysis suggests that the compounded preparations retain > 95% of the stated initial potency of HC regardless of storage conditions. Thus HC creams prepared in VersaPro™ cream base can be safely assigned a beyond the use date of two months when stored at room temperature.   Type: Original Research