EUTECNIQ Sciences

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Discovery & characterization Regulatory requirement Peer-reviewed methods Agency and NIST sources Proposed capability

Development starts with proving what the plant is, what it contains and what could be wrong with it

A botanical needs a confirmed identity, a chemical profile that captures its natural variability, and a screen for adulterants and contaminants before extraction or formulation.

Status. EUTECNIQ has no laboratory. Microscopy, HPTLC, HPLC and LC-MS are planned for Phase I; DNA methods and NMR would go to qualified partners (platform plan). Examples summarize published sources.

Academy fundamentals: Course 3, Botanical identity · Course 4, Genomes and species

8 of 37St John's wort samples adulterated with synthetic dyes; 6 more had non-conforming fingerprints
6chemotypes of one species, Thymus vulgaris, each with a different dominant monoterpene
800 mg/dayEGCG in supplements at or above which trials showed raised serum transaminases
350unique structures recorded for Ginkgo biloba in COCONUT

Frommenwiler et al., J AOAC Int 2016; Thompson et al., J Chem Ecol 2003; EFSA, EFSA J 2018; COCONUT, October 2026 dump. Published results, not EUTECNIQ data.

Identity, variability and contamination are three separate questions

  1. Identity needs more than one method. Macroscopy, microscopy, HPTLC and fingerprints combine; DNA helps with raw material, rarely with extracts.
  2. The plant varies. Chemotype, region, season, harvest and drying change composition, so specifications rest on many lots.
  3. A marker is not an active. A marker shows identity or quantity; it does not prove which constituents cause an effect.
Why it matters

Every later result is only as good as the identity and composition of the starting material

Four published adulterations, each made to pass a check of the expected marker or colorPeer-reviewed studies
Four published adulterations of St. John's wort, ginkgo and turmeric: the check each was built to pass, what was added, and the method that revealed itBotanical, study and samplesflaggedA check of the expected signalWhat was addedWhat revealed itSt. John's wortFrommenwiler et al. 2016St. John's wort: Synthetic dyes (37 samples)St. John's wort: Synthetic dyes (37 samples)St. John's wort: Synthetic dyes (37 samples)St. John's wort: Synthetic dyes (37 samples)St. John's wort: Synthetic dyes (37 samples)St. John's wort: Synthetic dyes (37 samples)St. John's wort: Synthetic dyes (37 samples)St. John's wort: Synthetic dyes (37 samples)St. John's wort: Flavonoid fingerprint unlike USP (37 samples)St. John's wort: Flavonoid fingerprint unlike USP (37 samples)St. John's wort: Flavonoid fingerprint unlike USP (37 samples)St. John's wort: Flavonoid fingerprint unlike USP (37 samples)St. John's wort: Flavonoid fingerprint unlike USP (37 samples)St. John's wort: Flavonoid fingerprint unlike USP (37 samples)St. John's wort: Not flagged (37 samples)St. John's wort: Not flagged (37 samples)St. John's wort: Not flagged (37 samples)St. John's wort: Not flagged (37 samples)St. John's wort: Not flagged (37 samples)St. John's wort: Not flagged (37 samples)St. John's wort: Not flagged (37 samples)St. John's wort: Not flagged (37 samples)St. John's wort: Not flagged (37 samples)St. John's wort: Not flagged (37 samples)St. John's wort: Not flagged (37 samples)St. John's wort: Not flagged (37 samples)St. John's wort: Not flagged (37 samples)St. John's wort: Not flagged (37 samples)St. John's wort: Not flagged (37 samples)St. John's wort: Not flagged (37 samples)St. John's wort: Not flagged (37 samples)St. John's wort: Not flagged (37 samples)St. John's wort: Not flagged (37 samples)St. John's wort: Not flagged (37 samples)St. John's wort: Not flagged (37 samples)St. John's wort: Not flagged (37 samples)St. John's wort: Not flagged (37 samples)8 with synthetic dyes6 more: fingerprint unlike USP37 extracts, products and rawherbsStandard USP HPTLCfingerprintOdd solution colors and unusualfingerprints prompted a closerlookSynthetic dyes0.51–1.36% by weightHPTLC with added white-lightdetectionReversed-phase HPTLC separatedthe polar dyes; densitometry andHPTLC-MS confirmed themGinkgo leaf productsWohlmuth et al. 2014Ginkgo leaf products: Adulterated (8 samples)Ginkgo leaf products: Adulterated (8 samples)Ginkgo leaf products: Adulterated (8 samples)Ginkgo leaf products: No evidence of adulteration (8 samples)Ginkgo leaf products: No evidence of adulteration (8 samples)Ginkgo leaf products: No evidence of adulteration (8 samples)Ginkgo leaf products: No evidence of adulteration (8 samples)Ginkgo leaf products: No evidence of adulteration (8 samples)3 of 8 retail productsFlavonol glycosides assayedas aglycones after acidhydrolysisUSP–NF, British and Europeanpharmacopoeia assaysFree flavonol aglyconesPlus genistein, an isoflavone thatdoes not occur in ginkgo leafAglycones assayed before andafter hydrolysisThe difference estimates the genuineglycosidesTurmeric: pigmentForsyth et al. 2019Color and brightnessA visual check of the yellowLead chromate pigment,PbCrO4​Added to brighten the colorElemental analysis by ICP-MSUSP ‹2232› limits elementalcontaminants in supplementsTurmeric: curcuminoidsPerini et al. 2023Curcuminoid profileHPLC with UV detectionSynthetic curcuminoidsBlended in natural ratios, so theprofile matchesCarbon-14 analysisMost effective published test; stableC and H isotope ratios proposed as acheaper screenFour published adulterations of St. John's wort, ginkgo and turmeric: the check each was built to pass, what was added, and the method that revealed itSt. John's wortFrommenwiler et al. 2016St. John's wort: Synthetic dyes (37 samples)St. John's wort: Synthetic dyes (37 samples)St. John's wort: Synthetic dyes (37 samples)St. John's wort: Synthetic dyes (37 samples)St. John's wort: Synthetic dyes (37 samples)St. John's wort: Synthetic dyes (37 samples)St. John's wort: Synthetic dyes (37 samples)St. John's wort: Synthetic dyes (37 samples)St. John's wort: Flavonoid fingerprint unlike USP (37 samples)St. John's wort: Flavonoid fingerprint unlike USP (37 samples)St. John's wort: Flavonoid fingerprint unlike USP (37 samples)St. John's wort: Flavonoid fingerprint unlike USP (37 samples)St. John's wort: Flavonoid fingerprint unlike USP (37 samples)St. John's wort: Flavonoid fingerprint unlike USP (37 samples)St. John's wort: Not flagged (37 samples)St. John's wort: Not flagged (37 samples)St. John's wort: Not flagged (37 samples)St. John's wort: Not flagged (37 samples)St. John's wort: Not flagged (37 samples)St. John's wort: Not flagged (37 samples)St. John's wort: Not flagged (37 samples)St. John's wort: Not flagged (37 samples)St. John's wort: Not flagged (37 samples)St. John's wort: Not flagged (37 samples)St. John's wort: Not flagged (37 samples)St. John's wort: Not flagged (37 samples)St. John's wort: Not flagged (37 samples)St. John's wort: Not flagged (37 samples)St. John's wort: Not flagged (37 samples)St. John's wort: Not flagged (37 samples)St. John's wort: Not flagged (37 samples)St. John's wort: Not flagged (37 samples)St. John's wort: Not flagged (37 samples)St. John's wort: Not flagged (37 samples)St. John's wort: Not flagged (37 samples)St. John's wort: Not flagged (37 samples)St. John's wort: Not flagged (37 samples)8 with synthetic dyes6 more: fingerprint unlike USP37 extracts, products and raw herbsStandard USP HPTLC fingerprintOdd solution colors and unusual fingerprints prompted acloser lookSynthetic dyes0.51–1.36% by weightHPTLC with added white-light detectionReversed-phase HPTLC separated the polar dyes;densitometry and HPTLC-MS confirmed themGinkgo leaf productsWohlmuth et al. 2014Ginkgo leaf products: Adulterated (8 samples)Ginkgo leaf products: Adulterated (8 samples)Ginkgo leaf products: Adulterated (8 samples)Ginkgo leaf products: No evidence of adulteration (8 samples)Ginkgo leaf products: No evidence of adulteration (8 samples)Ginkgo leaf products: No evidence of adulteration (8 samples)Ginkgo leaf products: No evidence of adulteration (8 samples)Ginkgo leaf products: No evidence of adulteration (8 samples)3 of 8 retail productsFlavonol glycosides assayed as aglycones afteracid hydrolysisUSP–NF, British and European pharmacopoeia assaysFree flavonol aglyconesPlus genistein, an isoflavone that does not occur inginkgo leafAglycones assayed before and after hydrolysisThe difference estimates the genuine glycosidesTurmeric: pigmentForsyth et al. 2019Color and brightnessA visual check of the yellowLead chromate pigment, PbCrO4​Added to brighten the colorElemental analysis by ICP-MSUSP ‹2232› limits elemental contaminants insupplementsTurmeric: curcuminoidsPerini et al. 2023Curcuminoid profileHPLC with UV detectionSynthetic curcuminoidsBlended in natural ratios, so the profile matchesCarbon-14 analysisMost effective published test; stable C and H isotoperatios proposed as a cheaper screen
Frommenwiler DA, et al. J AOAC Int. 2016;99(5):1204–1212. Wohlmuth H, et al. Phytomedicine. 2014;21(6):912–918. Forsyth JE, et al. Environ Res. 2019;179:108722. Perini M, et al. Antioxidants. 2023;12(2):498. USP ‹2232›. Sample counts are those reported in each study's abstract.
Text version of the requirement and the four cases

Identity test for every dietary ingredient 21 CFR 111.75. Part 111 requires a supplement manufacturer to “conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient,” unless FDA grants a petition for alternative testing (eCFR, 21 CFR 111.75(a)(1), up to date as of October 20, 2026).

Adulteration is documented Published. Published surveys found synthetic dyes in St. John's wort ingredients, free flavonol aglycones and genistein in ginkgo products, and lead chromate pigment added to turmeric. Each case defeated a test that looked only at the expected marker or color.

  • St. John's wort: of 37 dry extracts, finished products and bulk raw herbs analyzed by the USP HPTLC method with added white-light detection, 8 contained synthetic dyes (0.51–1.36% by weight) and 6 others had flavonoid fingerprints different from the USP specification. Reversed-phase HPTLC separated the polar dyes; scanning densitometry and HPTLC-MS confirmed them (Frommenwiler et al. 2016).
  • Ginkgo: three of eight retail products contained added free flavonol aglycones, and the same three contained genistein, an isoflavone that does not occur in ginkgo leaf. The pharmacopoeial assays quantify flavonols as aglycones after hydrolysis, so they cannot detect this; assaying aglycones before and after hydrolysis can (Wohlmuth et al. 2014).
  • Turmeric: lead chromate (PbCrO4), a yellow pigment, has been added to brighten the color; elemental analysis by ICP-MS detects it (Forsyth et al. 2019; USP ‹2232›).
  • Turmeric: synthetic curcuminoids are hard to detect because they can be blended in natural ratios; carbon-14 analysis is the most effective published test, and stable carbon and hydrogen isotope ratios have been proposed as a cheaper screen (Perini et al. 2023).
Explanation, details and sources

Part 111 requires a supplement manufacturer to “conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient.” A wrong or variable raw material invalidates the stability, safety and clinical work built on it.

EUTECNIQ would deliver identity, fingerprint, contaminant and variability data as one documented package that a buyer, regulatory team or development partner can review. Proposal

Botanical identity

Identity is confirmed by orthogonal methods, each blind to something the others see

Seven identity methods: what each establishes, what it misses and which material it works onCompendial and peer-reviewed sources
Seven botanical identity methods: what each establishes, what it is blind to, which material forms it works on, and whether it is planned in house or with a partnerMorphologyGeneticsChemistryMacroscopyMicroscopyDNA barcodingHPTLCHPLC, UHPLCLC-MS, GC-MSNMR profilingEstablishesBlind toPlant part, grossmorphology,foreign matterPowdered orextractedmaterialDiagnostic cellsand tissues;some powderedsubstitutesExtracts; needs atrained analystand a referenceSpecies of rawmaterial; somespecies mixturesChemical quality;extracts may holdlittle usable DNAVisual fingerprintagainst abotanicalreferenceClose relatives orspiked markerscan mimic thepatternQuantitativeprofile of mainconstituents;marker assaysAnything itsdetector cannotsee; an addedmatching markerIndividualconstituents,unexpectedcompounds;volatilesConfident identitywithout referencespectra orstandardsWhole-extractprofile withstructuralinformationMinorconstituents(lower sensitivity)Raw materialMacroscopy on raw material: applicableMicroscopy on raw material: applicableDNA barcoding on raw material: applicableHPTLC on raw material: applicableHPLC, UHPLC on raw material: applicableLC-MS, GC-MS on raw material: applicablePowderMacroscopy on powder: not applicableMicroscopy on powder: applicableDNA barcoding on powder: applicable with limitsHPTLC on powder: applicableHPLC, UHPLC on powder: applicableLC-MS, GC-MS on powder: applicableExtractMacroscopy on extract: not applicableMicroscopy on extract: not applicableDNA barcoding on extract: applicable with limitsHPTLC on extract: applicable with limitsHPLC, UHPLC on extract: applicableLC-MS, GC-MS on extract: applicableNMR profiling on extract: applicablePlannedPhase IPhase IPartnerPhase IPhase IPhase IPartnerApplicableApplicable with limitsNot applicableNot listedProcessing removes the visual evidence, so extracts depend on chemistrySeven botanical identity methods: what each establishes, what it is blind to, which material forms it works on, and whether it is planned in house or with a partnerEstablishesBlind toMacroscopyPhase IPlant part, gross morphology, foreign matterPowdered or extracted materialMacroscopy on raw material: applicableRaw materialMacroscopy on powder: not applicablePowderMacroscopy on extract: not applicableExtractMicroscopyPhase IDiagnostic cells and tissues; some powderedsubstitutesExtracts; needs a trained analyst and a referenceMicroscopy on raw material: applicableRaw materialMicroscopy on powder: applicablePowderMicroscopy on extract: not applicableExtractDNA barcodingPartnerSpecies of raw material; some species mixturesChemical quality; extracts may hold little usableDNADNA barcoding on raw material: applicableRaw materialDNA barcoding on powder: applicable with limitsPowderDNA barcoding on extract: applicable with limitsExtractHPTLCPhase IVisual fingerprint against a botanical referenceClose relatives or spiked markers can mimic thepatternHPTLC on raw material: applicableRaw materialHPTLC on powder: applicablePowderHPTLC on extract: applicable with limitsExtractHPLC, UHPLCPhase IQuantitative profile of main constituents; markerassaysAnything its detector cannot see; an addedmatching markerHPLC, UHPLC on raw material: applicableRaw materialHPLC, UHPLC on powder: applicablePowderHPLC, UHPLC on extract: applicableExtractLC-MS, GC-MSPhase IIndividual constituents, unexpected compounds;volatilesConfident identity without reference spectra orstandardsLC-MS, GC-MS on raw material: applicableRaw materialLC-MS, GC-MS on powder: applicablePowderLC-MS, GC-MS on extract: applicableExtractNMR profilingPartnerWhole-extract profile with structural informationMinor constituents (lower sensitivity)Raw materialPowderNMR profiling on extract: applicableExtractApplicableApplicable with limitsNot applicableNot listed
USP general chapters ‹563› and ‹203› (USP–NF; titles verified October 22, 2026). Parveen I, et al. Planta Med. 2016;82(14):1225–1235. Raclariu AC, et al. Phytochem Anal. 2018;29(2):123–128. “Phase I” and “Partner” are EUTECNIQ proposals (platform plan), not existing capabilities.
Text version: identity methods, what they establish and their limits
Botanical identity methods, what they establish, the materials they work on and their limits
MethodWhat it establishesWorks onLimitsPlanned
Macroscopic and organoleptic examinationPlant part, gross morphology, foreign matterWhole and cut raw materialLost once material is powdered or extractedPhase I
MicroscopyDiagnostic cells and tissues; some powdered substitutesRaw material and powdersNeeds a trained analyst and authenticated reference; not applicable to extractsPhase I
High-performance thin-layer chromatography (HPTLC)A visual chemical fingerprint compared with a botanical reference materialRaw material, powders, many extractsQualitative; closely related species or spiked markers can mimic parts of the patternPhase I
HPLC and UHPLC fingerprintA quantitative profile of the main constituents; marker assaysAll formsSees only what the detector and method can see; a matching marker can be addedPhase I
LC-MS and GC-MSIdentity of individual constituents; unexpected compounds; volatiles by GC-MSAll formsNeeds reference spectra or standards for confident identificationPhase I
NMR profilingA whole-extract chemical profile with structural informationExtractsLower sensitivity for minor constituents; specialist equipmentPartner
DNA barcoding and metabarcodingSpecies identity of raw material; species mixtures in some processed productsRaw material best; processed material with limitsUniversal primers are not recommended as the sole identification for processed plant material; extracts may contain little usable DNA, and DNA says nothing about chemical qualityPartner

The published recommendation is a combination: DNA methods with specific primers, chemical analysis, and microscopic and macroscopic examination.

Academy: documented adulteration rates · HPTLC and fingerprint calculators (Course 3)

Explanation, details and sources

Pharmacopoeial identity tests combine appearance, microscopy and the chemical profile. Processing removes the visual evidence, so extracts depend on chemistry.

Chemotype and variability

The same species can carry a different chemistry, so specifications are built from lot data

One species, six chemistries: the Thymus vulgaris chemotypes and their dominant monoterpenesPeer-reviewed study
Six chemotypes of Thymus vulgaris named after the dominant monoterpene of the essential oil: thymol and carvacrol (phenolic), geraniol, alpha-terpineol, linalool and thuyanol (non-phenolic)Phenolic chemotypes: isomers, C10​H14​ONon-phenolic chemotypes: geraniol, α-terpineol and linalool are isomers, C10​H18​OOHThymolOHCarvacrolOHGeraniolOHα-TerpineolOHLinaloolThuyanolFour characteristicmonoterpenes that togethermake up a smaller share of theoil than the single dominantmonoterpene of the othernon-phenolic chemotypesEnd of the biosynthetic chain. The oil alsocarries large amounts of the precursorsγ-terpinene and p-cymene, so the dominantmonoterpene is a smaller share of it.In the geraniol, α-terpineol and linalool chemotypes the dominant monoterpene is a larger share of the oil thanin the phenolic ones. The chemotypes show marked spatial segregation; many populations hold two or three.For every chemotype, the dominant monoterpene is a significantly smaller share of the oil at sites where that chemotype is not the majority type.
Thompson JD, Chalchat JC, Michet A, Linhart YB, Ehlers B. J Chem Ecol. 2003;29(4):859–880 (abstract). Structures drawn from PubChem: thymol CID 6989, carvacrol CID 10364, geraniol CID 637566, α-terpineol CID 17100, linalool CID 6549 (retrieved October 23, 2026); formulas computed with RDKit. The thuyanol chemotype is defined by four monoterpenes, so no single structure is drawn.

A buyer who orders “thyme” without a chemotype has not specified the chemistry.

From source variability to a specification, with retained samples behind every lotProposed sequence
Proposed path from source variability to a specification: four sources of variation feed lot data, chemometric pattern analysis, a specification and monitoring, with retained voucher and reserve samplesSources of variationChemotype and plant partWhich compounds the plantmakes, and whereRegion: climate and soilSeason and developmentalstageAt harvestDrying and post-harvesthandlingProposed EUTECNIQ sequenceLot dataIdentity tests,fingerprint and markerassays on every lotPatternChemometriccomparison withauthenticatedreference lotsSpecificationIdentity criteria,acceptance ranges,contaminant limitsMonitoringSupplier qualificationand trend reviewNew lots and suppliers re-enter the comparisonRetained: a voucher specimen per source and areserve sample per lotAny lot can be re-examined laterProposed path from source variability to a specification: four sources of variation feed lot data, chemometric pattern analysis, a specification and monitoring, with retained voucher and reserve samplesSources of variationChemotype and plantpartWhich compounds theplant makes, and whereRegion: climate and soilSeason anddevelopmental stageAt harvestDrying and post-harvesthandlingLot dataIdentity tests, fingerprint and marker assays on every lotPatternChemometric comparison with authenticated referencelotsSpecificationIdentity criteria, acceptance ranges, contaminant limitsMonitoringSupplier qualification and trend reviewRetained: voucher specimen per source and reserve sampleper lot, so any lot can be re-examined
Sources of variation: Goodarzi M, Russell PJ, Vander Heyden Y. Anal Chim Acta. 2013;804:16–28; Li Y, et al. Plant Physiol Biochem. 2020;148:80–89. The sequence is an EUTECNIQ proposal.
Text version of the chemotype evidence and the proposed sequence

Chemotypes. Thymus vulgaris has six chemotypes, named after the dominant monoterpene of their essential oil (thymol, carvacrol, geraniol, α-terpineol, linalool and thuyanol), that show marked spatial segregation in nature; many populations hold two or three chemotypes. The phenolic chemotypes (thymol and carvacrol) occur at the end of the biosynthetic chain; their oil carries large amounts of the precursors γ-terpinene and p-cymene, so their dominant monoterpene is a smaller share of the oil than in the non-phenolic geraniol, α-terpineol and linalool chemotypes. The thuyanol chemotype has four characteristic monoterpenes that together make up a smaller share of the oil than the single dominant monoterpene of the other non-phenolic chemotypes. For all chemotypes, the dominant monoterpene's share falls significantly at sites where that chemotype is not the majority type (Thompson et al. 2003).

Growing and processing conditions. The constituents of a herb and their amounts differ with growing conditions such as climate and soil, with the drying process and with the harvest season. Developmental stage and environment both affect secondary metabolites (Goodarzi et al. 2013; Li et al. 2020).

What a specification needs Proposal. EUTECNIQ would set ranges from multiple lots across suppliers, regions and seasons, record chemotype and plant part, and retain voucher and reserve samples so that any lot can be re-examined.

  1. SourceSpecies, chemotype, plant part, region, season, harvest stage.
  2. Lot dataIdentity tests, fingerprint and marker assays on every lot.
  3. PatternChemometric comparison against authenticated reference lots.
  4. SpecificationIdentity criteria, acceptance ranges and contaminant limits.
  5. MonitoringSupplier qualification and trend review over time.

Academy: the genetics behind chemotypes, including Acorus ploidy (Course 4)

Explanation, details and sources

A chemotype is a population of one species that makes a distinct set of compounds. Within a chemotype, climate and soil, harvest season, developmental stage and drying still shift the profile.

Chemical fingerprinting

A fingerprint compares the whole profile, so it catches problems a single marker misses

A marker can pass while the profile fails, and chemometrics turns the comparison into a decisionIllustrative chromatograms
Illustrative chromatograms of an authenticated reference lot and a test lot: the marker peak matches, but the whole-profile comparison shows a missing minor peak and an extra peak; the chemometric steps that followMarker assay: within range in both lotsAuthenticatedreference lotTest lotPeak absent from the referenceMinor constituent missingRetention time (illustrative)The marker passes; the whole-profile comparison flags the lotProfilesHPLC or UHPLC with UV or DAD: quantitative workhorse ·LC-MS: peak identities, minor and unexpectedconstituents · GC-MS: volatiles such as essential-oilterpenes · HPTLC: fast visual comparisonSimilarity analysisHow closely the lot's chromatogram matches thereferencePCA and classification modelsWhich lots cluster together, and which do notSubstantial equivalenceDoes the material match one with a history of use, or anearlier lot?
Illustrative: each trace is a sum of Gaussian peaks whose positions and heights were chosen for display; it is not a measured chromatogram. Methods and chemometric steps: Goodarzi M, Russell PJ, Vander Heyden Y. Anal Chim Acta. 2013;804:16–28. Wolfender J-L, Marti G, Thomas A, Bertrand S. J Chromatogr A. 2015;1382:136–164.
Text version of the profiling methods and chemometric steps

Profiles.

  • HPLC or UHPLC with UV or diode-array detection: the quantitative workhorse for most constituent classes.
  • LC-MS: identities of peaks, minor and unexpected constituents.
  • GC-MS: volatile constituents such as essential-oil terpenes.
  • HPTLC: a fast visual comparison with a botanical reference material.

Chemometrics.

  • Similarity analysis: how closely a lot's chromatogram matches the reference.
  • Principal component analysis and classification models: which lots cluster together, and which do not.
  • Substantial equivalence: whether a material matches one with a history of use or an earlier commercial lot.
Explanation, details and sources

How far a similarity score can be trusted is worked through on Purification and standardization.

Botanical materials and extracts often contain hundreds of compounds. Chromatographic fingerprinting compares the entire profile with authenticated reference material, not a few peaks.

Markers and actives

Markers are chosen for control, whether or not they cause any effect

Two kinds of marker and three kinds of extract, set by how much of the activity is explainedAgency guidance
EMA marker types and extract categories: markers serve control; active markers contribute to activity, analytical markers serve analysis; standardized, quantified and other extracts differ in how much of the activity identified constituents explain and in how they are controlledMarkerA chemically defined constituent “of interest for control purposes independentof whether they have any therapeutic activity”Active markerGenerally accepted to contribute to theactivityAnalytical markerServes solely for analysisExtract categoriesStandardized extractStandardized extract: share of the proven activity explained by identified constituentsThe identified constituents fully account for theproven activityAdjusted to a definedcontentQuantified extractQuantified extract: share of the proven activity explained by identified constituentsThe identified constituents account only partlyfor the activityKept within a definedrangeOther extractOther extract: share of the proven activity explained by identified constituentsThe whole extract is considered the activematerialDefined by its productionprocess and specificationShare of the proven activity explained by the identified constituents:fullypartlythe whole extract is taken as the active material
EMA HMPC. Reflection paper on markers used for quantitative and qualitative analysis of herbal medicinal products and traditional herbal medicinal products. EMEA/HMPC/253629/2007, 15 July 2008. Extract categories as described by Monagas M, et al. Front Pharmacol. 2022;13:981978, citing EMA (2010). Links from marker type to category: EMA declaration guideline EMA/HMPC/CHMP/CVMP/287539/2005 Rev. 1 (see Purification and standardization).
Turmeric's three curcuminoids share one backbone and differ only in methoxy groups: two, one or noneReference structures
Skeletal formulas of curcumin, demethoxycurcumin and bisdemethoxycurcumin. They share one backbone, two 4-hydroxyphenyl rings joined by a seven-carbon chain with two carbonyls, and differ only in the number of methoxy groups, two, one or none, drawn in teal.
Structures: PubChem isomeric SMILES, CIDs 969516, 5469424, 5315472 (retrieved Oct 25, 2026); RDKit 2026.09 2D depiction, β-diketone forms as recorded; highlights from an RDKit substructure search. Generated illustration, EUTECNIQ. Full-size SVG
Text version of the marker types and extract categories

EMA distinguishes active markers, generally accepted to contribute to activity, from analytical markers, which serve solely for analysis.

  • Standardized extracts. The identified constituents are understood to fully account for the extract's proven activity, so the extract is adjusted to a defined content.
  • Quantified extracts. The identified constituents account only partly for the activity; their content is kept within a defined range.
  • Other extracts. The whole extract is considered the active material; it is defined by its production process and specification.
  • A marker within specification≠Proof of activity
  • A higher plant-to-extract ratio≠A stronger or better extract
  • A passed identity test≠Absence of adulterants or contaminants
  • Traditional use≠Clinical proof
Explanation, details and sources

The European Medicines Agency defines markers as chemically defined constituents “of interest for control purposes independent of whether they have any therapeutic activity.”

Adulteration & contamination

Each hazard class needs its own test, because none of them shows up in an identity test

Ten hazards and the methods that screen for them: identity methods reach only the first two rowsCompendial and published sources
Ten adulteration and contamination hazards against ten screening methods: the three identity methods catch substitution and, in modified form, spiking; every contaminant needs its own targeted methodIdentity methodsTargeted contaminant methodsMicroscopyDNAHPTLCHPLCfingerprintIsotoperatiosICP-MSGC-MS,GC-MS/MSLC-MS/MSTargetedHPLCHeadspaceGCMicrobialtestsSpecies substitution, dilutionUSP ‹563›, ‹203›; 21 CFR 111.75Species substitution, dilution: Microscopy DNASpecies substitution, dilution: HPTLCSpecies substitution, dilution: HPLC fingerprintSpiking with markers or dyesMonograph tests plus targeted methodsSpiking with markers or dyes: HPTLC (modified or targeted form)Spiking with markers or dyes: HPLC fingerprint (modified or targeted form)Spiking with markers or dyes: Isotope ratiosToxic pigmentsUSP ‹2232›Toxic pigments: ICP-MSElemental contaminantsUSP ‹2232›Elemental contaminants: ICP-MSPesticide residuesUSP ‹561›: limits for 70 pesticidesPesticide residues: GC-MS, GC-MS/MSPesticide residues: LC-MS/MSMycotoxinsSpecification limits; EU maximum levelsMycotoxins: LC-MS/MSMycotoxins: Targeted HPLCPolycyclic aromatic hydrocarbonsSpecification limits; market maximum levelsPolycyclic aromatic hydrocarbons: GC-MS, GC-MS/MSPolycyclic aromatic hydrocarbons: Targeted HPLCPyrrolizidine alkaloidsSpecification limitsPyrrolizidine alkaloids: LC-MS/MSMicrobial contaminationUSP ‹2021›, ‹2022›, ‹2023›Microbial contamination: Microbial testsResidual solventsICH Q3C as a benchmarkResidual solvents: Headspace GCScreening method named for this hazardOnly in a modified or targeted formGrey text under each hazard: the framework that sets its test or limit
Methods are those named in the sources below; they are common practice, not requirements. Frameworks: USP general chapters ‹561›, ‹563›, ‹203›, ‹2021›, ‹2022›, ‹2023›, ‹2232› (titles verified on USP–NF, October 22, 2026); 21 CFR 111.75; ICH Q3C.
Text version: hazards, published examples, screening methods and frameworks
Adulteration and contamination hazards, examples, screening methods and frameworks
HazardPublished example or mechanismHow it is screenedFramework
Species substitution and dilutionSt. John's wort ingredients with flavonoid fingerprints that did not match the USP specificationHPTLC, HPLC fingerprint, microscopy, DNA for raw materialUSP <563>, <203>; 21 CFR 111.75
Spiking with markers or dyesFree flavonol aglycones and genistein in ginkgo products; synthetic dyes in St. John's wort; synthetic curcuminoids in turmericProfiles that separate free from bound forms; reversed-phase HPTLC for dyes; isotope ratios for synthetic originMonograph tests plus targeted methods
Toxic pigmentsLead chromate added to turmeric to brighten its colorElemental analysis (ICP-MS)USP <2232> Elemental Contaminants in Dietary Supplements
Elemental contaminantsToxic elements such as lead, taken up from soil or introduced during processingICP-MSUSP <2232>
Pesticide residuesAgricultural residues on cultivated and wild-collected materialGC-MS/MS and LC-MS/MS multi-residue methodsUSP <561> Articles of Botanical Origin sets limits for residues of 70 pesticides
MycotoxinsAflatoxins and ochratoxin A are the mycotoxins most often described in herbal productsLC-MS/MS or immunoaffinity clean-up with HPLCSpecification limits; EU maximum levels where applicable
Polycyclic aromatic hydrocarbonsFormed when combustion gases contact material during heating and drying; environmental pollution; concentrated by extractionGC-MS or HPLC with fluorescenceSpecification limits; market-specific maximum levels
Pyrrolizidine alkaloidsExamined as a possible contaminant of green tea extracts in the USP safety reviewLC-MS/MSSpecification limits
Microbial contaminationBacteria, yeasts and molds from field, storage and handlingMicrobial enumeration; tests for specified organismsUSP <2021>, <2022>, <2023>
Residual solventsSolvent left after extractionHeadspace GCICH Q3C as a benchmark; see Extraction

Frommenwiler DA, et al. J AOAC Int. 2016;99(5):1204–1212. Wohlmuth H, et al. Phytomedicine. 2014;21(6):912–918. Perini M, et al. Antioxidants. 2023;12(2):498. Forsyth JE, et al. Environ Res. 2019;179:108722. USP general chapters <561>, <2021>, <2022>, <2023>, <2232> (titles verified on USP–NF, October 22, 2026); 70-pesticide figure: Marles R, USP stakeholder forum presentation "Pesticide Residues" (2019). Ałtyn I, Twarużek M. Toxins. 2020;12(3):182. Holland J, Rose M, Petch S. Occurrence of polycyclic aromatic hydrocarbons in herbs, spices, supplements and tea. FERA for the UK Food Standards Agency; 2015. Oketch-Rabah HA, et al. Toxicol Rep. 2020;7:386–402. Analytical methods listed are common practice, not requirements.

Explanation, details and sources

Adulteration is deliberate; contamination comes from the field, the dryer or the process. Specifications set limits for both, using compendial methods where they exist.

From plant to molecule

Choose a botanical to see how it is identified, what it contains, how it is measured and what could go wrong

Four documented botanicals, from cited public sources; concentrations depend on lot, extract and method, so none are given.

St. John's wort Hypericum perforatum L., herb (Hyperici herba)

Family
Hypericaceae
Part used
Herb (flowering aerial parts)
EU status
EU herbal monograph, revision 1 (EMA/HMPC/7695/2021) EMA
U.S. status
USP monograph identity method by HPTLC USP
St. John's wort: hypericin, hyperforin and hyperoside, how the herb is identified and measured, and the hyperforin interaction chainPublished sources; PubChem structures
St. John's wort: three constituent classes drawn from PubChem structures (hypericin, hyperforin, hyperoside), how they are measured, and the hyperforin to PXR to CYP3A4 interaction chainNaphthodianthroneOOOHOHOHOHOHOHHypericinC30​H16​O8​ · 504.45 g/molPhloroglucinol derivativeOOOOHHyperforinC35​H52​O4​ · 536.80 g/molFlavonol glycoside of quercetinOOOHOHOOOHOHOHOHOHOHHyperosideC21​H20​O12​ · 464.38 g/molIdentified byMacroscopy and microscopy of the herb; HPTLC fingerprint against a reference (USPmonograph), with added white-light detection; reversed-phase HPTLC for added polar dyesMeasured byHPLC or LC-MS for naphthodianthrones, phloroglucinols and flavonoids; scanningdensitometry and HPTLC-MS to confirm dyesAlso a riskLarge oral doses or skin application may cause severe skin reactions after sun exposure(NCCIH)Interaction chainHyperforinActivates the pregnane X receptorInduces CYP3A4“Can weaken the effects of manymedicines”Including transplant, HIV, anticoagulant andcontraceptive drugsProcess leverReviewers report that removing hyperforinduring extraction can avoid the enzymeinduction without major loss of activity
PubChem: hypericin CID 3663, hyperforin CID 441298, hyperoside CID 5281643 (retrieved October 23, 2026); formula and molecular weight computed with RDKit. Mechanism: Moore LB, et al. Proc Natl Acad Sci USA. 2000;97(13):7500–7502; NCCIH (May 2025). Process lever: Nahrstedt A, Butterweck V. J Nat Prod. 2010;73(5):1015–1021.
Hyperforin, C35H52O4 in three dimensionsPubChem structure
One low-energy conformer computed with RDKit (ETKDG v3, MMFF94) from the PubChem SMILES; not a crystal structure. PubChem CID 441298; NPClassifier (COCONUT): polyketide, meroterpenoid. Drag or use the arrow keys to rotate.
Full text: identification, constituents, measurement and risks

Development question. Hyperforin links quality to safety: it induces CYP3A4 through PXR, and reviewers report that removing it during extraction can avoid that induction without major loss of activity. Its content is therefore a process and safety specification, not only a quality one.

1 · Identity

How it is identified

Macroscopy and microscopy of the herb; HPTLC fingerprint against a reference following the USP monograph; reversed-phase HPTLC was developed to separate added polar dyes.

2 · Constituent classes

What it contains

Naphthodianthrones (mainly hypericin and pseudohypericin); phloroglucinol derivatives (mainly hyperforin and adhyperforin); flavonol glycosides of quercetin (hyperoside, rutin, isoquercitrin, quercitrin); biflavones; small amounts of caffeoylquinic acids.

3 · Characterization

How it is measured

HPTLC with additional white-light detection; HPLC or LC-MS for naphthodianthrones, phloroglucinols and flavonoids; scanning densitometry and HPTLC-MS to confirm dyes.

4 · Safety and quality

What could go wrong

Hyperforin induces CYP3A4 through the pregnane X receptor, and St. John's wort "can weaken the effects of many medicines," including transplant, HIV, anticoagulant and contraceptive drugs. Large oral doses or skin application may cause severe skin reactions after sun exposure. In one survey, 8 of 37 samples contained synthetic dyes and 6 had non-conforming flavonoid fingerprints.

5 · Development question

Why it matters for EUTECNIQ's work

Reviewers report that removing hyperforin during extraction can avoid the enzyme-induction side effect without major loss of activity; the hyperforin content of an extract is therefore a process and safety specification, not only a quality one.

EMA HMPC. Assessment report on Hypericum perforatum L., herba, EMA/HMPC/244315/2016 Rev. 1 (23 November 2022) and EU herbal monograph page (accessed October 22, 2026). Moore LB, et al. Proc Natl Acad Sci USA. 2000;97(13):7500–7502. Nahrstedt A, Butterweck V. J Nat Prod. 2010;73(5):1015–1021. NCCIH. St. John's Wort: Usefulness and Safety (May 2025). Frommenwiler DA, et al. J AOAC Int. 2016;99(5):1204–1212.

Ginkgo Ginkgo biloba L., leaf (Ginkgo folium)

Family
Ginkgoaceae
Part used
Leaf
EU status
EU herbal monograph (2015): dry extract, well-established use; powdered leaf, traditional use EMA
Reference material
NIST SRM 3246 Ginkgo biloba (Leaves) NIST
Ginkgo: why a hydrolysis-based flavonol assay cannot see added aglycones, and the fixPublished sources; PubChem structures
Ginkgo: why the compendial flavonol assay cannot see added free aglycones. Genuine glycosides and added aglycones both become quercetin, kaempferol and isorhamnetin after acid hydrolysis; assaying before and after hydrolysis separates them. Genistein, an isoflavone absent from ginkgo leaf, was found in the same products.Genuine extractFlavonols bound to sugars asglycosidesAdulterated productFewer glycosides, plus freeflavonol aglycones addedAcid hydrolysisSugars cleavedWhat the assay measures: the aglyconesOOOHOHOHOHOHQuercetinC15​H10​O7​ · 302.24 g/molOOOHOHOHOHKaempferolC15​H10​O6​ · 286.24 g/molOOOOHOHOHOHIsorhamnetinC16​H12​O7​ · 316.26 g/molSame totalBound andadded free formsread alikeThe fix proposed by Wohlmuth et al.Assay the aglycones before and after hydrolysis. Before: freeaglycones only. After minus before: the genuine glycosides. Theauthors also recommend a maximum limit for free aglycones.Three of eight retail products held added free aglycones; the samethree contained genistein.Terpene trilactones (ginkgolides A, B, C and J; bilobalide) are measuredseparately, by reversed-phase HPLC with evaporative light-scattering,refractive-index or mass detection, or by GC after silylation.OOOHOHOHGenisteinC15​H10​O5​ · 270.24 g/molAn isoflavone: the B-ring sits on C-3, notC-2 as in the flavonols, and there is no3-OHDoes not occur in ginkgo leafSafetyInteractions and seedsMay increase bleeding risk with anticoagulants such as warfarin; freshseeds are toxic (NCCIH)Rodent carcinogenicity, one extractNTP TR-578: clear evidence in mice (liver), some evidence in rats (thyroid)
PubChem: quercetin CID 5280343, kaempferol CID 5280863, isorhamnetin CID 5281654, genistein CID 5280961 (retrieved October 23, 2026); formula and molecular weight computed with RDKit. Wohlmuth H, et al. Phytomedicine. 2014;21(6):912–918. van Beek TA, Montoro P. J Chromatogr A. 2009;1216(11):2002–2032.
Ginkgolide B, C20H24O10 in three dimensionsPubChem structure
One low-energy conformer computed with RDKit (ETKDG v3, MMFF94) from the PubChem SMILES; not a crystal structure. PubChem CID 11973122; a diterpene trilactone (EFSA 2024). Drag or use the arrow keys to rotate.
Full text: identification, constituents, measurement and risks

Development question. The identity method itself must be able to detect the known adulterant. A certified reference material, NIST SRM 3246, supports validation for flavonoids, terpene lactones and toxic elements.

1 · Identity

How it is identified

Macroscopy and microscopy of the leaf; HPTLC; a combined profile of flavonol glycosides and terpene trilactones. USP–NF and the European and British pharmacopoeias have monographs for the leaf, leaf extract and finished products.

2 · Constituent classes

What it contains

Terpene trilactones (ginkgolides A, B, C and J; bilobalide); flavonol glycosides; biflavones; proanthocyanidins; alkylphenols; simple phenolic acids. Several of these classes are no longer present in the common standardized extracts.

3 · Characterization

How it is measured

Terpene trilactones by reversed-phase HPLC with evaporative light-scattering, refractive-index or mass detection, or by GC after silylation. Flavonol glycosides are usually assayed as the aglycones quercetin, kaempferol and isorhamnetin after acid hydrolysis.

4 · Safety and quality

What could go wrong

Because the compendial flavonol assays hydrolyze first, they cannot tell genuine glycosides from added free aglycones; three of eight retail products in one study were adulterated this way and also contained genistein. Ginkgo may increase bleeding risk with anticoagulants such as warfarin, and fresh seeds are toxic. In NTP rodent studies of one ginkgo extract, there was clear evidence of carcinogenic activity in mice (liver) and some evidence in rats (thyroid).

5 · Development question

Why it matters for EUTECNIQ's work

The identity method itself must be able to detect the known adulterant: an assay of free aglycones before and after hydrolysis was proposed for that purpose. A certified reference material supports method validation for flavonoids, terpene lactones and toxic elements.

EMA. Ginkgo folium, EU herbal monograph page (accessed October 22, 2026). van Beek TA, Montoro P. J Chromatogr A. 2009;1216(11):2002–2032. Wohlmuth H, et al. Phytomedicine. 2014;21(6):912–918. NCCIH. Ginkgo: Usefulness and Safety (February 2025). National Toxicology Program. TR-578, Toxicology and Carcinogenesis Studies of Ginkgo Biloba Extract, levels of evidence. NIST. Certificate of Analysis, SRM 3246.

Turmeric Curcuma longa L., rhizome (Curcumae longae rhizoma)

Family
Zingiberaceae
Part used
Rhizome
EU status
EU herbal monograph, revision 1 (2019), traditional use EMA
Note
Also a common spice, so food-grade and supplement-grade supply chains overlap
Turmeric: the three curcuminoids and four documented problems with what detects or controls eachPublished sources; PubChem structures
Turmeric: the three curcuminoids drawn from PubChem structures, and four documented quality and safety problems with the method that addresses eachCurcuminoids: one methoxy group fewer at each stepOOOOHOOHCurcuminC21​H20​O6​ · 368.39 g/molOOOOHOHDemethoxycurcuminC20​H18​O5​ · 338.36 g/molOOOHOHBisdemethoxycurcuminC19​H16​O4​ · 308.33 g/molWhat has gone wrong, and what detects or controls itLead chromate pigment, PbCrO4​Added to brighten the colorElemental analysis by ICP-MSSynthetic curcuminoidsHard to detect: blended in natural ratios,the HPLC profile matchesCarbon-14 analysis; stable Cand H isotope ratios as acheaper screenLiver injuryTen turmeric-associated casesdescribed by the U.S. Drug-InducedLiver Injury Network; NCCIH notes highlybioavailable formulations, for examplewith piperine, may harm the liverRaising exposure with adelivery system raises a safetyquestionAssay interferenceCurcumin is unstable and reactive andhas been classified as a pan-assayinterference compoundIn vitro activity claims needcareful controlsAlso measured: the volatile oil (zingiberene, curcumene, ar-turmerone, α- and β-turmerone) by GC-MS, and lead and other elements by ICP-MS.
PubChem: curcumin CID 969516, demethoxycurcumin CID 5469424, bisdemethoxycurcumin CID 5315472 (retrieved October 23, 2026); formula and molecular weight computed with RDKit. Forsyth JE, et al. 2019. Perini M, et al. 2023. Halegoua-DeMarzio D, et al. Am J Med. 2023;136(2):200–206. NCCIH (April 2025). Nelson KM, et al. J Med Chem. 2017;60(5):1620–1637. EMA/HMPC/329745/2017.
Curcumin, C21H20O6 in three dimensionsPubChem structure
One low-energy conformer computed with RDKit (ETKDG v3, MMFF94) from the PubChem SMILES; not a crystal structure. PubChem CID 969516; NPClassifier (COCONUT): linear diarylheptanoid. Drag or use the arrow keys to rotate.
Full text: identification, constituents, measurement and risks

Development question. Curcumin is chemically unstable and reactive, so in vitro activity claims need careful controls; raising exposure with a delivery system also raises a safety question.

1 · Identity

How it is identified

Macroscopy and microscopy of the rhizome or powder; HPTLC and HPLC profiles of the curcuminoids and volatile oil. A matching curcuminoid profile does not prove natural origin.

2 · Constituent classes

What it contains

Curcuminoids (curcumin, demethoxycurcumin and bisdemethoxycurcumin); an essential oil of mono- and sesquiterpenes including zingiberene, curcumene, ar-turmerone and α- and β-turmerone; carbohydrates, protein and fatty oil.

3 · Characterization

How it is measured

HPLC with UV detection for curcuminoids; GC-MS for the volatile oil; ICP-MS for lead and other elements. Carbon-14 analysis is the most effective published test for synthetic curcuminoids; stable carbon and hydrogen isotope ratios have been proposed as a cheaper screen.

4 · Safety and quality

What could go wrong

Lead chromate pigment has been added to turmeric to brighten its color. Synthetic curcuminoids are hard to detect because they can be blended in natural ratios. The U.S. Drug-Induced Liver Injury Network described ten turmeric-associated liver-injury cases, and NCCIH notes that highly bioavailable formulations, for example with piperine, may harm the liver.

5 · Development question

Why it matters for EUTECNIQ's work

Curcumin is chemically unstable and reactive and has been classified as a pan-assay interference compound, a frequent source of false positives in laboratory assays, so in vitro activity claims need careful controls. Raising exposure with a delivery system also raises a safety question.

EMA HMPC. Assessment report on Curcuma longa L., rhizoma, EMA/HMPC/329745/2017 (25 September 2018), and EU herbal monograph page (accessed October 22, 2026). Forsyth JE, et al. Environ Res. 2019;179:108722. Perini M, et al. Antioxidants. 2023;12(2):498. Halegoua-DeMarzio D, et al. Am J Med. 2023;136(2):200–206. NCCIH. Turmeric: Usefulness and Safety (April 2025). Nelson KM, et al. J Med Chem. 2017;60(5):1620–1637.

Green tea Camellia sinensis (L.) Kuntze, unfermented leaf

Family
Theaceae
Part used
Leaf, not fermented
EU status
EU herbal monograph (2014) EMA
Reference material
NIST SRM 3254 Green Tea (Camellia sinensis) Leaves NIST
Green tea: EGCG and caffeine, the EFSA intake at which liver enzymes rose, and what changes exposurePublished sources; PubChem structures
Green tea: EGCG and caffeine drawn from PubChem structures, the EFSA intake at which serum transaminases rose, and the factors that change exposureOOHOHOHOHOHOOOHOHOHEGCGC22​H18​O11​ · 458.38 g/molCatechins: most of the polyphenolsNNONONCaffeineC8​H10​N4​O2​ · 194.19 g/molMethylxanthinesEGCG taken as a food supplement, mg per day800 mg EGCG per day or more as a food supplement: significant increase in serum transaminases (EFSA 2018)02004006008001,000≥ 800 mg/day: serum transaminases rosesignificantly in clinical trials (EFSA)Dosing patternRepeated bolus doses taken fastingmarkedly increase EGCGbioavailability (USP review)ManufacturingCatechin profiles vary with themanufacturing process (USPreview)InteractionHigh intakes of green tea reducedblood levels of the drug nadolol(NCCIH)Contaminants examinedSolvent residues, pesticides,pyrrolizidine alkaloids and elements:no evidence they caused the liverinjuries (USP review)Reference material: NIST SRM 3254 green tea leaves, for validating catechin,xanthine and element analyses; also characterized for DNA sequence.
PubChem: EGCG CID 65064, caffeine CID 2519 (retrieved October 23, 2026); formula and molecular weight computed with RDKit. EFSA ANS Panel. EFSA J. 2018;16(4):e05239. Oketch-Rabah HA, et al. Toxicol Rep. 2020;7:386–402. NCCIH (February 2025). NIST Certificate of Analysis, SRM 3254.
Epigallocatechin gallate, C22H18O11 in three dimensionsPubChem structure
One low-energy conformer computed with RDKit (ETKDG v3, MMFF94) from the PubChem SMILES; not a crystal structure. PubChem CID 65064; NPClassifier (COCONUT): flavan-3-ol. Drag or use the arrow keys to rotate.
Full text: identification, constituents, measurement and risks

Development question. For a concentrated extract, the EGCG dose, the dosing pattern and the label become safety specifications.

1 · Identity

How it is identified

Leaf morphology and microscopy for raw material; HPLC fingerprint of catechins and methylxanthines; DNA for leaf material. The NIST reference leaves are characterized for DNA sequence as well as chemistry.

2 · Constituent classes

What it contains

Catechins, which are most of its polyphenols, with (−)-epigallocatechin-3-gallate (EGCG) the most relevant; methylxanthines, including caffeine.

3 · Characterization

How it is measured

HPLC for catechins and xanthines and ICP-MS for elements, the analyses NIST SRM 3254 is intended to validate; residual solvents, pesticides and pyrrolizidine alkaloids as contaminant screens.

4 · Safety and quality

What could go wrong

EFSA concluded that 800 mg EGCG per day or more, taken as a food supplement, significantly increased serum transaminases in clinical trials. A USP review found that catechin profiles vary with manufacturing and that repeated bolus doses taken fasting markedly increase EGCG bioavailability. High intakes of green tea reduced blood levels of the drug nadolol.

5 · Development question

Why it matters for EUTECNIQ's work

For a concentrated extract, the EGCG dose, the dosing pattern and the label become safety specifications. The same USP review examined solvent residues, pesticides, pyrrolizidine alkaloids and elements and found no evidence that they caused the liver injuries.

EMA. Camelliae sinensis non fermentatum folium, EU herbal monograph page (accessed October 22, 2026). EFSA ANS Panel. Scientific opinion on the safety of green tea catechins. EFSA J. 2018;16(4):e05239. Oketch-Rabah HA, et al. Toxicol Rep. 2020;7:386–402. NCCIH. Green Tea: Usefulness and Safety (February 2025). NIST. Certificate of Analysis, SRM 3254.

How these summaries were built, and what they do not establish
What it shows
For each botanical: identity methods, constituent classes, characterization methods, and published safety and quality questions, each traced to an agency document or peer-reviewed source listed under the panel.
Selection
Four botanicals with an EU herbal monograph, a large peer-reviewed literature and documented quality or safety issues. They are teaching examples, not products EUTECNIQ proposes to make.
What it does not establish
No compound concentrations are given, because they depend on the lot, the extract and the method. Nothing here is a safety assessment, a dose recommendation or an efficacy claim; traditional use and in vitro activity are not clinical proof.
Verification
Sources were checked against the agency pages, PubMed abstracts or full texts on October 22, 2026; see the claim manifest for this page.
What the literature records for each botanical: share of known structures by biosynthetic pathwayOpen data, computed
COCONUT 2.0, October 2026 dump (CC0): unique 2D structures whose organism field names the species or genus; pathway from the dump's NPClassifier fields (phenylpropanoids = shikimates and phenylpropanoids; peptides = amino acids and peptides). Counts reflect published reports aggregated in COCONUT, not a complete inventory of the plant. Hover a cell for the count; method on the targeted and non-targeted analysis page.
Data table
Unique 2D structures recorded in COCONUT by NPClassifier pathway (count and share of the row)
Species or genus (structures)TerpenoidsAlkaloidsShikimates and phenylpropanoidsFatty acidsPolyketidesAmino acids and peptidesCarbohydratesNo pathway assigned
Hypericum perforatum (319)97 (30.4%)8 (2.5%)85 (26.6%)60 (18.8%)61 (19.1%)0 (0.0%)7 (2.2%)1 (0.3%)
Ginkgo biloba (350)46 (13.1%)29 (8.3%)168 (48.0%)27 (7.7%)33 (9.4%)30 (8.6%)12 (3.4%)5 (1.4%)
Curcuma longa (345)160 (46.4%)12 (3.5%)97 (28.1%)48 (13.9%)3 (0.9%)1 (0.3%)3 (0.9%)21 (6.1%)
Camellia sinensis (644)227 (35.2%)61 (9.5%)229 (35.6%)68 (10.6%)8 (1.2%)22 (3.4%)11 (1.7%)18 (2.8%)
Hypericum (genus) (2,363)672 (28.4%)94 (4.0%)879 (37.2%)124 (5.2%)508 (21.5%)22 (0.9%)15 (0.6%)49 (2.1%)
Ginkgo (genus) (354)48 (13.6%)29 (8.2%)170 (48.0%)27 (7.6%)33 (9.3%)30 (8.5%)12 (3.4%)5 (1.4%)
Curcuma (genus) (942)444 (47.1%)78 (8.3%)254 (27.0%)75 (8.0%)17 (1.8%)27 (2.9%)11 (1.2%)36 (3.8%)
Camellia (genus) (952)398 (41.8%)67 (7.0%)326 (34.2%)85 (8.9%)18 (1.9%)25 (2.6%)12 (1.3%)21 (2.2%)
Reference standards

Every identity and assay result is a comparison, so the reference material decides how much it can be trusted

Three kinds of reference behind a result: compendial, certified and retainedSchematic
Three kinds of reference behind an identity or assay result: compendial reference standards, certified reference materials, and the proposed voucher specimens and retained samplesCompendialUSP monographs and generalchapters such as ‹203›Specify the reference standards andbotanical reference materialsThe identity or assay test is runagainst themCertifiedNIST SRM 3246 ginkgo leaves; SRM3254 green tea leavesValidate analytical methods; assignvalues to in-house control materialsMethods and in-house controlschecked against certified valuesProposedAn authenticated voucher specimenper sourceA retained sample of every lotIdentity re-examined if a questionarises later
USP–NF general chapter ‹203›. NIST Certificates of Analysis, SRM 3246 and SRM 3254. The third row is an EUTECNIQ proposal.
Text version of the three kinds of reference

Compendial reference standards

USP monographs and general chapters such as <203> specify the reference standards and botanical reference materials an identity or assay test is run against.

Certified reference materials

NIST Standard Reference Materials for botanicals, such as SRM 3246 (Ginkgo biloba leaves) and SRM 3254 (green tea leaves), are intended for validating analytical methods and assigning values to in-house control materials.

NIST Certificates of Analysis, SRM 3246 and SRM 3254.

Vouchers and retained samples Proposal

EUTECNIQ would keep an authenticated voucher specimen for each source and a retained sample of each lot, so identity can be re-examined if a question arises later.

EUTECNIQ's role

What EUTECNIQ proposes to deliver, and what it would place with partners

EUTECNIQ would build the identity file, variability report, screen and draft specification in house; partners would add DNA, NMR and wider panelsProposed division of work
Proposed characterization deliverables: EUTECNIQ would build the identity file, the variability report, the elemental and microbial screen and the draft specification in its planned Phase I laboratory; partners would add DNA barcoding, NMR, accredited confirmation, wider contaminant panels and regulatory counselPlanned in houseQualified external partnerIdentity filePhase IMacroscopy, microscopy, HPTLC, HPLC and LC-MS againstreference materialsPartnerDNA barcoding and NMRComposition andvariability reportPhase IFingerprints and marker assays across lots; chemometriccomparisonPartnerAccredited confirmatory testingContaminant screenPhase IElemental analysis by ICP-MS; microbiologyPartnerPesticide, mycotoxin and PAH panels where outside theplanned scopeDraft specificationPhase IIdentity criteria, acceptance ranges, contaminant limits,sampling planPartnerRegulatory counsel for market-specific limitsEUTECNIQ holds no laboratory or ISO/IEC 17025 accreditation; every row is a proposal.Proposed characterization deliverables: EUTECNIQ would build the identity file, the variability report, the elemental and microbial screen and the draft specification in its planned Phase I laboratory; partners would add DNA barcoding, NMR, accredited confirmation, wider contaminant panels and regulatory counselIdentity filePlanned in house · Phase IMacroscopy, microscopy, HPTLC, HPLC and LC-MSagainst reference materialsQualified external partner · PartnerDNA barcoding and NMRComposition and variability reportPlanned in house · Phase IFingerprints and marker assays across lots;chemometric comparisonQualified external partner · PartnerAccredited confirmatory testingContaminant screenPlanned in house · Phase IElemental analysis by ICP-MS; microbiologyQualified external partner · PartnerPesticide, mycotoxin and PAH panels where outsidethe planned scopeDraft specificationPlanned in house · Phase IIdentity criteria, acceptance ranges, contaminantlimits, sampling planQualified external partner · PartnerRegulatory counsel for market-specific limitsEUTECNIQ holds no laboratory or ISO/IEC 17025accreditation; every row is a proposal.
Facility plan, October 2026 (Phase I laboratory). The same four rows are in the table below. No laboratory, method or accreditation exists.
Show the table (4 rows): Proposed in-house characterization work and partner work
Proposed in-house characterization work and partner work
DeliverablePlanned in houseQualified external partner
Identity filePhase I Macroscopy, microscopy, HPTLC, HPLC and LC-MS against reference materialsPartner DNA barcoding and NMR
Composition and variability reportPhase I Fingerprints and marker assays across lots; chemometric comparisonPartner Accredited confirmatory testing
Contaminant screenPhase I Elemental analysis by ICP-MS; microbiologyPartner Pesticide, mycotoxin and PAH panels where outside the planned scope
Draft specificationPhase I Identity criteria, acceptance ranges, contaminant limits, sampling planPartner Regulatory counsel for market-specific limits
Explanation, details and sources

ISO/IEC 17025 accreditation is granted per laboratory for a defined scope of tests. EUTECNIQ holds no accreditation; see Analytical technologies for the planned laboratory.

Sourcing a botanical you need to characterize?

Tell us the species, plant part, origin and product category; EUTECNIQ would propose a characterization plan.

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