Chemical Stability of Hydrocortisone in Topical Preparation in Proprietary VersaProTM Cream Base

Abstract

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