Science meets regulation

Ethnopharmacological relevance: TheEuropeanPharmacopoeia(Ph.Eur.)isastandardreferenceforboth European andnon-Europeancountriesanddefines requirementsforthequalitativeandquantitative composition ofmedicines.Herbaldrug(HD)monographsstatewhichaspectshavetobeconsideredfor qualityassurancethroughtherelevantchapters “Definition”, “Characters”, “Identification”, “Tests”, and “Assay”. Identification ofbotanicalmaterialisachievedbymacroscopicandmicroscopicmorphology, generallyexaminedbyatrainedexpert.Contentorassayisthemostdifficult areaofqualitycontrolto perform, sinceinmostherbaldrugstheactiveconstituentsareunknownandmarkersshouldbeused which cannotbereallyrelatedtothequality.Theothercriticalpointsarerepresentedbythepuritytests, in particularsometestssuchasheavymetals,aflatoxinsandpesticidesarelaboriousandtimeintensive, requiringasignificant investmentinequipment,materials,andmaintenance. Material andmethods: Aliteraturesurveyconcerningalternativeand/orcomplementarytoolsfor qualitycontrolofbotanicalshasbeenperformedbysearchingthescientific databasesPubmed,SciFinder, Scopus andWebofScience. Results: DiverseanalyticalmethodsincludingDNA fingerprinting, NuclearMagneticResonance (NMR), NearInfraRed(NIR)and(bio)sensorshavebeenreportedintheliteraturetoevaluatethe qualityofbotanicalproducts.Identification ofplantsatthespecieslevelcanbesuccessfullybasedon genome-based methods,usingDNAbarcodes,thenucleotidesequenceofashortDNAfragment.NMR can providedirectNMR fingerprint determination(completeassignmentofthesignalsby1Dand2D experiments),quantitativeNMRandchemometricanalysis(themetabolite fingerprint isbasedonthe distribution ofintensityintheNMRspectrumtoprovidesampleclassification). NIRspectroscopyisafast qualitativeandquantitativeanalyticalmethod,gettingknowledgeaboutplantspeciesand/orits geographicorigin.Finally,thedevelopmentofchemicalandbiologicalsensorsiscurrentlyoneofthe most activeareasofanalyticalresearch.Immobilizationofspecific enzymesledtorecognizedefinite class ofcompoundssuchascysteinesulfoxides,glucosinolates,cyanogenicglycosides,andpolyphenols. Other recognitionelementsarenucleicacidstoevaluatetheabilityofdifferentmoleculestobindDNA. Sensors havealsobeendevelopedforthedetectionofheavymetalsinbotanicals.Moreover,theanalysis of micotoxinsandpesticides,couldrepresentanother field ofpossibleapplication. Conclusions: Thesealternative/complementaryanalyticalmethodsrepresenttoolswhichappeartobe an analyst’s dream:theyareabletogiverapidanalysisresponses;tooperatedirectlyoncomplex matrices, inmanycases;tobeselectiveandsensitiveenoughfortherequiredapplication;tobeportable and sometimesalsodisposable;andtohavefastanalysistimes.