Abstract
Introduction. Rhodiola rosea is one of the most extensively studied adaptogens, however, the influence of extraction and drying process parameters on the stability of marker compounds has not been sufficiently investigated. Aim. Develop and scientifically substantiate a technology for producing a dry extract of Rhodiola rosea, as well as to validate this technology by assessing the impact of extraction parameters and drying methods on the preservation of biologically active compounds and the quality of the finished product. Materials and Methods. The study was conducted on three pilot-industrial batches. Risk analysis (FMEA) was carried out and critical process parameters (CPP) were identified. Statistical assessment was performed using control charts and process capability indices (Cp, Cpk) in Minitab® 21 software. Quality evaluation was conducted using pharmacopeial analytical methods. Results. The most critical stages of the process were identified as raw material preparation and extraction (RPN ≥ 40). All evaluated parameters demonstrated statistical control: Cp & Cpk values exceeded 1.5, indicating high process reproducibility. The residual moisture content of the final product in all batches was below 5%. The salidroside content exceeded 0.7%, and the total rosavins content was above 1.1%, meeting and surpassing the established minimum criteria. Microbiological purity indicators fully complied with pharmacopeial requirements. Conclusions. The development and validation of the technological process for obtaining a dry extract of Rhodiola rosea substantiated the optimal conditions for its production. Based on the FMEA analysis, critical process parameters were identified, and validation results confirmed their reproducibility and suitability for industrial application. Key words: Rhodiola rosea, dry extract, risk assessment, validation, salidroside, rosavins.