Safety and Standardization of Natural Product Materials: Origin Confirmation, Marker Compounds, Toxicity Testing, and Analytical Method Validation
Safety and Standardization
Even among natural product materials that share the same name, the composition can differ depending on the biological origin, the growing or harvesting environment, the time of harvest, and the processing method. For that reason, confirming exactly what an ingredient is, maintaining consistent quality, and evaluating safety when people consume it are prerequisites for all research and use.
This field is where analytical chemistry, toxicology, and regulatory science meet. Comparing and reproducing research results requires reporting standards that describe the composition of an extract in sufficient detail, and internationally, guidelines for characterizing extracts such as ConPhyMP are under discussion.
Main research topics
- 01Origin confirmation
Species identification through morphological identification and DNA barcoding, and identifying adulterants and counterfeits
- 02Quality standardization
Setting marker compounds, compound profile (fingerprint) analysis, and evaluating batch-to-batch consistency
- 03Analytical method validation
Verifying specificity, linearity, accuracy, precision, and limits of detection and quantification
- 04Control of contaminants
Analysis of and standards for heavy metals, pesticide residues, mycotoxins, and microbial contamination
- 05Toxicity assessment
Nonclinical safety studies such as single- and repeated-dose toxicity and genotoxicity
- 06Interactions and adverse events
Possible drug interactions and the collection and evaluation of adverse events after intake
Overview of methods
Origin is confirmed with voucher specimens and genetic analysis.
Marker compounds and composition are analyzed by HPLC, LC-MS, and other methods.
Analytical methods are verified following the principles of ICH Q2.
Nonclinical studies are carried out according to the OECD test guidelines.
The scientific basis of domestic and international standards and approval systems is studied.
- Heinrich M, Jalil B, Abdel-Tawab M, et al. Best practice in the chemical characterisation of extracts used in pharmacological and toxicological research — The ConPhyMP-Guidelines. Front Pharmacol 2022;13:953205.
- ICH (International Council for Harmonisation) Q2 — Validation of Analytical Procedures; ICH M3 — Nonclinical Safety Studies.
- OECD Guidelines for the Testing of Chemicals, Section 4: Health Effects.
- The Health Functional Foods Act and Ministry of Food and Drug Safety notices on the approval of functional ingredients for health functional foods (Korea).