Ginkgo leaf
English technical termGinkgo biloba leaf
Leaves of the botanical species Ginkgo biloba L.; identify the plant part separately from seeds or extracts.
Evidence to request
Ask for botanical identification, plant part, origin, harvest information and a matching raw-material batch number.
Technical reference: EMA · Ginkgo folium
Total flavonol glycosides
English technical termTotal flavonol glycosides · Flavone glycosides (specification wording)
Ginkgo specifications also use the wording “flavone glycosides”. A total calculated from aglycones after hydrolysis is not a direct measurement of intact glycosides; names alone do not make assay methods interchangeable.
Evidence to request
Ask for the named assay, calculation basis, units, target range and the actual batch result; a marketing percentage alone is insufficient.
Technical reference: NIFDC authors · Risk control in quality supervision of ginkgo extract (2017), section 1.1.3
Terpene lactones
English technical termTerpene lactones
A constituent group including ginkgolides and bilobalide; specify which components the reported total includes.
Evidence to request
Ask for the component list, assay method, total calculation and batch results against the agreed target.
Technical reference: EMA · Ginkgo biloba L., folium: assessment report
Ginkgolic acids
English technical termGinkgolic acids
A group controlled as an impurity parameter in relevant ginkgo extract specifications.
Evidence to request
Ask for the agreed limit, analytical method, detection or quantitation limit, units and the batch result; do not infer absence from an omitted result.
Technical reference: EMA · Ginkgo biloba L., folium: assessment report
HPLC
English technical termHigh-performance liquid chromatography · HPLC
An analytical separation technique. Naming HPLC does not identify the complete test method or prove compliance.
Evidence to request
Ask for the method reference and version, sample preparation, reference standards, chromatogram and suitability or validation evidence.
Technical reference: ICH Q2(R2) · Validation of analytical procedures
Certificate of Analysis
English technical termCertificate of Analysis · COA
A document reporting tests for an identified material and batch; it is not a general company certification.
Evidence to request
Match product and batch identity, test methods, acceptance limits, numerical results, issue date and authorised issuer.
Technical reference: ICH Q7 · Good manufacturing practice for active pharmaceutical ingredients
Drug-extract ratio
English technical termDrug-extract ratio · DER
The relationship between starting herbal material and the resulting extract; the native or genuine-extract basis matters.
Evidence to request
Ask for the ratio or range, starting-material basis, native-extract definition, yield basis and carrier content.
Technical reference: EMA · Declaration of herbal substances and preparations
Residual solvents
English technical termResidual solvents
Solvents that remain after processing; a declared extraction solvent does not state the final residue amount.
Evidence to request
Ask for the solvent panel, applicable limits, validated method, quantitation limits and actual batch values.
Technical reference: ICH Q3C(R9) · Residual solvents
Pesticide residues
English technical termPesticide residues
Residues assessed using a specified list of pesticides; an unspecified “pass” does not define the tested scope.
Evidence to request
Ask for the analyte list, destination-market basis, method, quantitation limits, sampling details and batch report.
Technical reference: EMA · Quality of herbal medicinal products
Elemental impurities / heavy metals
English technical termElemental impurities / heavy metals
Individual elements evaluated against an agreed specification; a single total does not replace element-specific results.
Evidence to request
Ask which elements were measured, the method and units, limits, batch values and the basis relevant to the intended product and market.
Technical reference: ICH Q3D · Elemental impurities
Microbial limits
English technical termMicrobial limits
Tests for microbial counts and specified organisms; the required panel depends on the material and intended application.
Evidence to request
Ask for the test panel, methods, sample quantity, acceptance criteria and batch-specific results.
Technical reference: EMA · Quality of herbal medicinal products
Batch traceability
English technical termBatch traceability
Records linking incoming material, processing, testing, packaging and dispatch to identifiable batches.
Evidence to request
Ask for linked batch identifiers, production and test dates, manufacturer identity and the document trail for the supplied lot.
Technical reference: ICH Q7 · Good manufacturing practice for active pharmaceutical ingredients