Supplemental Tables and Figures: In-Office Compounding of Buffered Lidocaine and Epinephrine – A Stability and Safety Review
Description
This research addresses in-office preparation and use of buffered lidocaine with epinephrine. Our multidisciplinary collaboration evaluates the stability, sterility, antimicrobial effectiveness, and safe compounding protocols for these preparations. The findings contribute significantly to the growing body of evidence supporting patient safety, regulatory compliance, and clinical efficiency in dermatologic surgery settings. Importantly, this study helps clarify the scientific rationale behind the recently developed monograph and joint position statements from leading dermatologic societies (American Academy of Dermatology, American College of Mohs Surgery, American Society for Dermatologic Surgery, and American Society for Mohs Surgery). Our data support assigning a beyond-use date (BUD) of 7 days under refrigeration and 24 hours at room temperature, in alignment with the updated U.S Pharmacopeial (USP) General Chapter <797> standards.
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Stability and sterility testing were conducted on multiple lots of buffered lidocaine with epinephrine prepared in syringes. Analytical methods validated potency, purity, pH, antimicrobial effectiveness, endotoxin, particulate matter, and container/closure integrity. Results demonstrated that preparations remained within specifications for potency, sterility, and safety parameters. Based on regression analysis, buffered lidocaine maintained stability for 24 hours at room temperature and up to 7 days under refrigeration when stored in capped syringes. The studies were performed according to U.S. Pharmacopeia (USP) specifications.