Standardisation is the process of ensuring that every batch of a herbal drug or extract contains a consistent, quantitatively defined amount of its designated bioactive or marker constituents, guaranteeing a reproducible therapeutic effect from batch to batch despite the inherent biological variability of plant-derived material. This phase examines the pharmacognostic physicochemical parameters, HPTLC and HPLC marker compound standardisation, microbial limit testing, heavy metal and pesticide residue analysis, and stability study design that together establish herbal drug quality and underpin every subsequent regulatory submission.
The pharmacognostic, chromatographic, and contaminant-testing parameters that underpin herbal drug standardisation and quality control.
