СТУДИЈА НА СТАБИЛНОСТ НА МАСЛЕН РАСТВОР ОД ЕКСТРАКТ ОД КАНАБИС 10mg THC + 10mg CBD/ml, 60ml
STABILITY STUDY OF CANNABIS EXTRACT OIL SOLUTION 10mg THC + 10mg CBD/ml, 60ml

Summary/Abstract: An oil solution of cannabinoids obtained from a cannabis flower extract containing 10 mg/ml Δ⁹ tetrahydrocannabinol and 10 mg/ml cannabidiol was subjected to stability and the results of a study performed under accelerated, intermediate and long term conditions were evaluated in accordance with ICH Q1A(R2) and Q1E guidelines. The active ingredients (cannabinoids) in the oil solution were obtained by extraction using supercritical CO₂ of cannabis flowers rich in Δ⁹ tetrahydrocannabinol and cannabis flowers rich in cannabidiol. The extract thus obtained, when added to an oil solution, has a full spectrum of components (in addition to cannabinoids, of great importance are also the terpenes). To confirm the stability of the product within the intended shelf life, the oil solution was placed on stability and the parameters indicative for this purpose were evaluated, such as the content of Δ⁹ tetrahydrocannabinol, the content of cannabidiol and the content of the degradation product cannabinol. Using a regression analysis of the values obtained for the parameter content of each component individually against time for three individual batches at three storage conditions (accelerated 6 months, intermediate 12 months and long term 24 months) and under a pooled model, with slope homogeneity confirmed by ANCOVA (α = 0.25), in accordance with the ICH stability guidelines, the shelf life during which the oil solution of cannabinoids maintains its quality within the prescribed specification, was defined. The shelf life is defined as the time during which the lower one sided 95% confidence limit of the mean value for content, intersects the lower 90% acceptance limit. The results showed a measurable decline in both Δ⁹ tetrahydrocannabinol and cannabidiol content over 24 months, with regression models for each batch individually estimating a shelf life of approximately 20 months. Pooled regression analysis supports a conservative shelf life of approximately 21 months. Cannabinol levels remained within specification limits throughout the study, across the three storage conditions. Early deviations from initial content values (greater than 5% of initial content analysis) suggest potential analytical variability or initial instability, which requires cautious interpretation of the data. The results of the study confirm that the oil solution of cannabinoids obtained from cannabis flower extract containing 10 mg/mL Δ⁹ tetrahydrocannabinol and 10 mg/mL cannabidiol shows variability related to the chemical instability of the cannabinoids. The application of statistical analysis based on regression provides a scientifically justified definition of a shelf life of 21 months for the product stored in its original packaging under the conditions specified on the packaging at temperatures up to 25°C.

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