hydrocortisone, stability, cream
The United States Pharmacopeia-National Formulary (USP-NF) suggests beyond use dating ((BUD) for compounded topical preparations containing active pharmaceutical ingredients (API) . 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.
Sarkar AB, Dudley R, Melethil S, Speidel J, Bhatt GM. Chemical Stability of Hydrocortisone in Topical Preparation in Proprietary VersaPro™ Cream Base. Inov Pharm. 2011;2(3): Article 54. http://pubs.lib.umn.edu/innovations/vol2/iss3/8.