Integrated quality and safety evaluation of spray-dried Centella asiatica extract powder for oral ingredient...

Spray drying converts botanical extracts into powder ingredients, but product-linked evidence is needed to verify quality and preliminary safety in the final oral-use formulation. This study evaluated a spray-dried Centella asiatica extract powder prepared from a 70% ethanol extract and maltodextrin. Asiaticoside contents in three independently manufactured lots ranged from 23.15 to 23.17 mg/g, and Lot 2022-001 met predefined specifications. The high-performance liquid chromatography method showed selectivity, linearity (R² = 0.9993-0.9997), recovery of 98.2-100.4%, an intermediate-precision relative standard deviation of 1.01%, and an expanded relative uncertainty of 2.46%. Six-month accelerated storage supported a model-based 24-month shelf-life. A single oral dose of 5,000 mg/kg caused no mortality, abnormal clinical signs, significant body-weight effects, or gross pathological findings in Sprague-Dawley rats. These results provide product-specific evidence for asiaticoside-based quality control, storage management, and preliminary acute hazard characterization.

The online version contains supplementary material available at https://doi.org/10.1007/s10068-026-02271-0.