COMPARATIVE STABILITY OF DRIED CANNABIS SATIVA L. FLOWER IN N₂-FLUSHED ALUMINUM LAMINATE BAGS VERSUS HDPE JARS UNDER ICH LONG-TERM STORAGE CONDITIONS

Abstract

This study evaluates the impact of packaging configuration and oxygen exposure on the chemical and microbiological stability of dried Cannabis sativa L. flower under controlled long-term storage conditions. Two commercially relevant packaging systems were compared: multilayer aluminum laminate bags packaged under nitrogen-modified atmosphere and high-density polyethylene jars sealed without inert gas. Four batches from two commercial strains with comparable cannabinoid potency were stored at 25 ± 2 °C and 60 ± 5 % relative humidity and analyzed at predefined time points up to nine months. Stability was assessed using validated pharmacopoeial and accredited analytical methods for active compound content, degradation indicators, moisture-related parameters, and microbiological quality. Descriptive trend analysis was applied due to single-sample testing per time point. The results demonstrate improved retention of Δ⁹-tetrahydrocannabinol in nitrogen-packaged laminate bags compared with ambient packaging, with all nitrogen-packaged samples remaining within specification throughout the study, whereas an out-of-specification result was observed in one ambient-packaged batch at the ninth month. Microbiological parameters remained within regulatory limits for both packaging systems, indicating maintained microbiological safety under controlled storage. The observed stability differences are attributed to the combined effect of reduced headspace oxygen and the superior barrier properties of aluminum laminate materials, which limit oxygen and water vapor ingress and reduce oxidative potential during storage. These findings support the use of nitrogen-modified atmosphere packaging as an effective strategy for improving the chemical stability of dried cannabis flower without compromising microbiological compliance. From a practical perspective, the results provide a performance-based framework for packaging selection in good manufacturing practice environments and support informed decision-making related to shelf-life definition and quality risk management. Future studies including identical packaging formats with and without nitrogen are recommended to further isolate the independent contribution of atmosphere modification.