Standardization of Herbal Extract Potency

Abstract

Potency standardisation is the specific pharmaceutical-quality problem of ensuring that successive batches of a given herbal extract deliver consistent biological activity. It differs from pharmacognostic identity confirmation (which ensures the right starting material) and from compound characterisation (which identifies what is in the extract) by asking the harder question of whether what is in the bottle will behave the same way clinically as what was in the last bottle. For Ayurvedic extracts entering European pharmaceutical and clinical research pipelines, potency standardisation is the quality-control layer that clinical trial design, regulatory approval, and commercial manufacturing simultaneously depend on. This study reviews 56 primary analytical and quality-control studies published between 2005 and 2021 on potency standardisation of Ayurvedic herbal extracts, grouped under five approach frames: S1 (single-marker quantitative standardisation), S2 (multi-marker chromatographic standardisation), S3 (bioassay-based potency standardisation), S4 (chromatographic fingerprint with statistical similarity scoring), and S5 (integrated analytical + bioactivity multi-dimensional standardisation). Each frame was scored with the Herbal Extract Standardisation Index (HESI). Integrated analytical + bioactivity multi-dimensional standardisation (S5) scored highest at HESI 0.848, with multi-marker chromatographic (S2) at 0.812 and bioassay-based (S3) at 0.790