The International Pharmacopoeia and International Chemic【精品PPT】

TheInternationalPharmacopoeiaandInternationalChemicalReferenceSubstancesDrSabineKoppQualityAssuranceandSafety MedicinesWorldHealthOrganization TheInternationalPharmacopoeia Int Ph IntroductionPh Int scopeWHOconsultativeprocedureTypesofmonographsSpecialfeaturesWHO srelatedactivities TheInternationalPharmacopoeia myth mysteryorrevival Myth OxfordDictionary7thed 1989 traditionalnarrativeusu involvingsupernaturalorfanciedpersonsetc andembodyingpopularideasinnaturalorsocialphenomenaetc suchnarrativescollectively allegory Platonic fictitiouspersonorthingoridea f Gkmythos TheInternationalPharmacopoeia myth mysteryorrevival mystery OxfordDictionary7thed 1989 1 1 hiddenorinexplicablematter 2 secrecy obscurity practiceof makingasecretof unimportant things 3 religioustruthdivinelyrevealed esp onebeyondhumanreasons religiousrite 4 inpl 5 miracleplay ME f AFmisterie OFmistereorf L f Gkmysterion 2 arch handicraft trade ME f med L mi ni sterium TheInternationalPharmacopoeia myth mysteryorrevival Revival OxfordDictionary7thed 1989 1 bringingorcomingbackintouseorvogue 2 reawakeningofreligiousfervour 3 restorationofbodilyormentalrigourortolifeorconsciousness TheInternationalPharmacopoeia myth mysteryorrevival Pharmacopoeia Ref TheInternationalPharmacopoeia preface collectionofrecommendedproceduresfortheanalysisandspecificationsforthedeterminationofpharmaceuticalsubstances excipientsanddosageforms Requirementsimplementedbylegislation InternationalPharmacopoeiaHistoricaloverview 1874DiscussiononUnificationofterminologyandcompositionofdrugs1902FirstConferenceorganizedbytheGovernmentofBelgium1906AgreementonUnificationoftheFormulaeofPotentDrugsratifiedby19states1925Brusselsagreement signed1929 LeagueofNations internationalpharmacopoeia InternationalPharmacopoeiaHistoricaloverview 2 1937Firstmeeting expertsfromB CH DK F NL UK USA LeagueofNations1947InterimCommissionofWHOtakesuphealthrelatedworkofLeagueofNations1948FirstWorldHealthAssemblyestablishedExpertCommitteeonUnificationofPharmacopoeia InternationalPharmacopoeiaHistoricaloverview 3 1950WHAapprovedpublicationofPharmacopoeiaInternationalisWHOExpertCommittee 1951named ExpertCommitteeonInternationalPharmacopoeia1959named ExpertCommitteeonSpecificationsforPharmaceuticalPreparations todate TheInternationalPharmacopoeia whoitisfor RegulatoryauthoritieslicensingassessorsinspectorsnationalmedicinescontrollaboratoriesManufacturerssupplierspurchasersThoseactingonbehalfofconsumerspublicanalysts hospitalQClaboratoriesprocurementagencies Typeofmonographs DrugsubstancesExcipientsFinisheddosageformsGeneralmethodsandrequirements oralsolddosageforms e g tabletsdissolutiontesting Methodsofanalysis ausercanexpectthatamethod hasbeenevaluatedissuitableforthespecifiedpurposeandthattheapparatusandreagentsarewidelyavailablereferencesubstancesandspectra wherespecified areavailable Methodsofanalysis ausercanalsoexpectthatamethod isdescribedclearlyandinsufficientdetailincludessystemssuitability performancewherenecessary feasiblewillbereviewed revisedtakeaccountofuserexperience post publishingsurveillance WHOProcedureforthepreparationofdrugQualityControlspecifications 1 orwhyittakessolong PreliminaryconsultationanddraftingDraftQualityControlspecificationsMethoddevelopment validation WHOCollaboratingCentresandexperts contractedlaboratoriesCirculationforcomments testingofsamplesRevisionprocess additionalstudies contactswithmanufacturersforqueriesandadditionalsamplesasneeded WHOdoesthework withPartners NationalandregionalauthoritiesInternationalorganizations UNAIDS UNFPA UNICEF WorldBank WIPO WTO WCO etc Internationalprofessionalandotherassociations NGOs includingconsumerassociations MSF industry IFPMA IGPA WSMI FIP WMA etc WHOExpertPanels officialnominationprocess Specialistsfromallareas regulatory university industry WHOCollaboratingCentres officialnominationprocess PharmacopoeiaCommissionsandSecretariats nationalinstitutionsandinstitutes Regionalandinterregionalgroups ICH WHOProcedureforthepreparationofdrugQualityControlspecifications 2 AdoptionbyWHOExpertCommitteeonSpecificationsforPharmaceuticalPreparationsPresentationtoWHOGoverningBodiesRecommendationtogovernmentsforimplementationpublicationinTechnicalReportsandTheInternationalPharmacopoeiaandBasicTestsseries InternationalPharmacopoeia current 4thedition implementation readyforuse byMemberStatesScopesince1975 ModelListofEssentialMedicinesandDrugsrecommendedbyWHOSpecificdiseaseprogrammes e g Malaria TB HIV AIDSandmedicinesforchildren 4thedition new Consolidatedin2Volumes CD ROM online Vol1 pharmaceuticalsubstances A O Vol2 pharmaceuticalsubstances P X dosageforms radiopharmaceuticals methodsofanalysis reagentsNew MonographsonantiretrovialsRevisionofexistingmonographsImprovedpresentationImprovedcross referencingtogeneralmethodsCD ROMandon line improvedsearchfunctions 4thedition new 2 Newnoticeon definition Newnoticeon manufacture NewnoticeonimpuritiesNewlistofimpuritiesshowntobecontrolledbytestsMoretocome firstsupplementinpreparationtocover NewmonographsforARVs TBandMalariamedicines medicinesforchildrenRevisionofothers e g toincludedissolutiontestsForpre informationvisittheWHOwebsite http www who int medicines publications pharmacopoeia overview NewSpecificationsadoptedby40thWHOExpertCommittee ARVs APIs abacavirsulfate efavirenz lamivudine stavudine zidovudine ARVs finishedproducts nelfinavirmesilatetablets nelfinavirmesilateoralpowder and saquinavirmesilatecapsulesfixed doseantituberculosismedicines rifampicintablets rifampicincapsules rifampicin isoniazidtablets rifampicin isoniazid pyrazinamide ethambutolHCltablets isoniazid ethambutolHCltablets rifampicin isoniazid pyrazinamidetablets NewSpecificationsadoptedby41stWHOExpertCommittee ARVs AbacaviroralsolutionAbacavirsulfatetabletsDidanosinetabletsDidanosineoralsolution adultformulation LamivudineoralsolutionLamivudinetabletsStavudinecapsulesZidovudinecapsulesZidovudineIVinjectionZidovudineoralsolutionZidovudineandLamivudinetabletsZidovudine LamivudineandAbacavirtablets NewSpecificationsadoptedby41stWHOExpertCommittee antimalarialmedicines Doxycyclinehyclatecapsules newmonograph Doxycyclinehyclatetablets revision Doxycyclinehyclate revision Lumefantrine newmonograph subjecttofurtherstudies NewSpecificationsadoptedby41stWHOExpertCommittee revisions dissolution MetronidazoletabletsDoxycyclinetabletsIsoniazidtabletsChloroquinephosphatetabletsPrimaquinediphosphatetabletsEthambutolhydrochloridetabletsPyrazinamidetabletsRifampicincapsulesRifampicintablets NewPh Int monographs adoptedby42ndWHOExpertCommittee LumefantrineArtemetherandlumefantrinetabletsRifampicin isoniazidandethambutoltabletsRifampicinandisoniaziddispersibletabletsRifampicin isoniazidandpyrazinamidedispersibletabletsZincsulfateZincsulfatetablets paediatricZincsulfateoralsolution paediatricMagnesiumsulfateinjection NewPh Int WorkProgramme adoptedby42ndWHOExpertCommittee MedicinesforHIV AIDS relatedconditionsAntibacterialsAntifungal antiprotazoalandantimycobacterialagentsAnti epilecticspaediatricformulations oralliquidsandchewabletablets AnthelminticsPalliativecareReproductivehealthInsulinsLargevolumeparenterals egglucoseIVinfusion InternationalPharmacopoeiaSpecialfeatures 1 whencomplex technicallydemandingmethodsaredescribed e g HPLC alesstechnicallydemandinganalyticalmethod e g TLC proposedasalternative ifpossible 2 internationalvalidation impurityprofilecanvaryfromcountrytocountry Exampleofmonograph didanosine DIDANOSINEC10H12N4O3RelativeMolecularMass 236 2Chemicalname 9 2R 5S 5 hydroxymethyl tetrahydrofuran 2 yl 1 9 dihydro 6H purin 6 one 9 2 3 dideoxy D glycero pentofuranosyl 1 9 dihydro 6H purin 6 one 2 3 dideoxyinosine DDI CASReg No 69655 05 6 Description Awhitetoalmostwhitepowder Solubility Sparinglysolubleinwater slightlysolubleinmethanolRandethanol 95percent RCategory Antiretroviral NucleosideReverseTranscriptaseInhibitor Storage Didanosineshouldbekeptinatightlyclosedcontainer Didanosinemonograph Requirements IdentitytestSpecificOpticalRotationHeavymetalsSulfatedashLossondryingRelatedSubstancesAssayImpuritiesReagents Didanosine Assay Dissolveabout0 200g accuratelyweighed in50mlglacialaceticacidR1andtitratewithperchloricacid 0 1mol l VSasdescribedunder Non aqueoustitration MethodA Vol 1 p 131 determiningtheend pointpotentiometrically Eachmlofperchloricacid 0 1mol l VSisequivalentto23 62mgofC10H12N4O3 RelatedSubstances extract Note PreparefreshsolutionsandperformthetestswithoutdelayCarryoutthetestasdescribedunder High performanceliquidchromatography Vol 5 p 257 usingastainlesssteelcolumn 25cmx4 6mm packedwithoctadecylsilylbase deactivatedsilicagelforchromatographyR 5 m 1 Maintainthecolumntemperatureat20 25 C Themobilephasesforgradientelutionconsistofamixtureofaqueousphase MobilephaseA andmethanol MobilephaseB usingthefollowingconditions MobilephaseA A0 05MsolutionofammoniumacetateRadjustedtopH8 0usinga20 v vammonia 260g l TS MobilephaseB Methanol 1HypersilBDSissuitable Didanosine Impurities Thefollowinglistofknownandpotentialimpuritiesthathavebeenshowntobecontrolledbythetestsinthismonographisgivenforinformation A 1 7 dihydro 6H purin 6 one hypoxanthine B 9 D ribofuranosyl 1 9 dihydro 6H purin 6 one inosine C 9 2 deoxy D erythro pentofuranosyl 1 9 dihydro 6H purin 6 one 2 deoxyinosine D 9 3 deoxy D erythro pentofuranosyl 1 9 dihydro 6H purin 6 one 3 deoxyinosine E 9 2 3 anhydro D ribofuranosyl 1 9 dihydro 6H purin 6 one 2 3 anhydroinosine WHO sstrategyforqualitycontrol Step wiseapproach Basictests identification Screeningtests TLC TheInternationalPharmacopoeiaInternationalreferencematerials ICRSandIRreferencespectra Int Ph andlinkswithotherprogrammesandorganizations EstablishmentofmonographsforantiretroviralscollaborationPh Eur USP JP IP ChinesePharmacopoeia BrazilianPharmacopoeia collaborationwithmanufacturerslinkswithWHO UNICEFprojectonprequalificationofsuppliersforHIVdrugs Int Ph andlinkswithotherprogrammesandorganizations Monographsforantimalarials anti TBdrugs differentclustersinWHO Generalrequirementsforproductsderivedfromplantmaterials WHOTraditionalMedicinesProgramme Monographsforradiopharmaceuticals withInternationalAtomicEnergyAgency IAEA Monographsforexcipients withPharmacopoeialDiscussionGroup PDG InternationalChemicalReferenceSubstances ICRS 202ICRS 12meltingpointreferencesubstancesEstablishedbyWHOCOLLABORATINGCENTREFORCHEMICALREFERENCESUBSTANCESinSwedenPrimaryreferencestandardLinkedtoPh Int PriceforICRSUS 70Includes Directionsforuseand CertificateofanalysisMonitoringandon goingstabilitytestingCanbeusedfortestsandanalysisnotincludedinPh Int InternationalChemicalReferenceSubstances ICRS Fororderinginformation pleasevisithttp www apl apoteket se who InternationalInfra redReferenceSpectra WHOCOLLABORATINGCENTREFORCHEMICALREFERENCESUBSTANCESinSweden69InternationalInfraredReferenceSpectra moreinpipeline LinkedtoPh Int Publicationunderreview IR spectrumoflamivudine WHO srelatedactivities 1 GoodPracticesforNationalPharmaceuticalControlLaboratoriesModelCertificateofAnalysisConsiderationsforrequestinganalysisofdrugsamplesBasictestsScreeningtests WHO srelatedactivities 2 WHOgoodmanufacturingpractice GMP forpharmaceuticalproductsandstartingmaterials activeingredientsandexcipients GoodTradeandDistributionPracticesforPharmaceuticalStartingMaterialsandGooddistributionpracticesformedicinesWHOGoodStoragePractices GSP WHOCertificationSchemeontheQualityofPharmaceuticalProductsMovinginInterna