Standardization of herbal medicines
Start with the big picture
Standardization begins with botanical authentication before processing, followed by physicochemical checks and chromatographic fingerprints that help establish identity, purity, and characteristic composition. Marker-compound assays quantify selected constituents, while contaminant and residual-solvent testing address safety. Controls span cultivation and storage through extraction and packaging, and stability studies help establish shelf life and storage conditions. Validated analytical methods, reference standards, and batch records support reliable results and traceability. When an official monograph is unavailable, in-house specifications can be developed in a pharmacopoeial style. Bioassays and post-marketing pharmacovigilance contribute further evidence about retained activity and product safety.
What you'll learn
- Explain why herbal medicines require batch-to-batch standardization.
- Describe how botanical authentication and physicochemical tests support identity and purity.
- Identify the roles of chromatographic fingerprints and marker-compound assays.
- Summarize supply-chain controls, contaminant testing, and stability assessment.
- Explain how validation, documentation, bioassays, and pharmacovigilance support quality assurance.
Continue your study
Work through the complete notes and reinforce the topic with the study tools available in the full lesson.
