European Pharmacopoeia New monographs and chapters in the European Pharmacopoeia
EuropeanPharmacopoeiaOrganisation
• TheEuropeanPharmacopoeia containsalargenumberofmonographs,amongthemabout70onradiolabelled radio-pharmaceuticalsandradioactiveprecursorsand5onnon-radioactiveprecursorsforradiosynthesis.
• Dr.EllenPelhaspresentedonhowtouseandhowtocontributetotheEuropeanPharmacopoeia.
• TheEuropeanPharmacopoeiahascurrentlythreegroupsworkingintheareaofradiopharmaceuticals:- ExpertGroup14(RadioactiveCompounds)
- PRPworkingParty(Precursorsforradiopharmaceuticalpreparations)
- CRPworkingParty(Productionandcompoundingofradiopharmaceuticalpreparations)
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New/changedmonographspublished since2014(Ed8.2)
Fludeoxyglucose(18F)injectionAcorrectionwasmadetothetestforchemicalpuritytohaveabettersystemsuitabilitytest
Technetium(99mTc)etifenininjectionThebiodistributiontestwasdeletedasanimprovedidentityandRCPtestwasintroducedwhichisinlinewiththe3Rpolicy(Replacement,ReductionandRefinementofanimaltesting).
Fluoroethyl-l-tyrosine(18F)injectionNewmonograph
Coppertetramibitetrafluoroborateforradiopharmaceuticalpreparations
Newmonograph
4/15/16 Ph.Eur.ESRR2016Salzburg
New/changedmonographspublished since2014(Ed8.2)Technetium(99mTc)medronateinjection
Thebiodistributiontestwasdeletedasanimproved identitytestwasintroduced.AlsothelimitforSnwasexpressedperV.AkitforthedeterminationofSnwasintroduced
Gallium(68Ga)edotreotideinjectionAcorrectionwasmadetotheamountofsampletobeappliedforthetestforHEPES
Technetium(99mTc)oxidronateinjectionNewMonograph
5.19.ExtemporaneouspreparationofradiopharmaceuticalsThisisaguidancemonograph(notbinding)onthepreparationofradiopharmaceuticals inahospital/radiopharmacyenvironment
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New/changedmonographspublished since2014(Ed8.2)
Pentetatesodiumcalciumforradiopharmaceuticalpreparationsupdatedtoincludea'variablequantityofwater'accordingtocurrentPh.Eur.policyonhydrates.
Fluorocholine(18F)injectionThemonographhasbeenpublishedinEd8.8oftheEuropeanPharmacopoeia. Burthemonographisunderreviewinordertoverifythenecessityofinclusionoffurtherimpurities,e.g.bromocholine
Chemicalprecursorsforradiopharmaceuticalpreparationstobediscussedlater
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WorkinProgressonRadiopharmaceuticalMonographs
Lutetium(177Lu)solutionforradiolabellingCommentsonthedrafthavebeendiscussedduringtheGroup14meetingprecedingthissymposium.Afinaldraftwillbemadetobesubmittedtothecommission
Sodiumpertechnetate(99mTc)injection(cyclotron-produced)CommentsonthedrafthavebeendiscussedduringtheGroup14meetingprecedingthissymposium.Afinaldraftwillbemadetobesubmittedtothecommission
Yttrium(90Y)solutionforradiolabellingThedraftofthismonographwillsoonbepublishedinPharmeuropaandwillbeopenforcomments
Choline(N-11C1)InjectionThemonographhasbeenpublishedinPharmeuropaandwasopenforcommentsuntilMarch31st 2016
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WorkinProgressonRadiopharmaceuticalMonographs
Fluoro-L-dopa(18F)(preparedbynucleophilicsubstitution)injectionAstarthasbeenmadewithdraftingthemonograph.Acomplicatingfactoristhemanydifferentsyntheticpathwaysusedbyproducers.
Fluciclovine(18F)injectionThelatestdraftwasdiscussedattherecentmeetingofGroup14.ItisexpectedtobepublishedinPharmeuropa29.4(October2016).
Technetium(99mTc)succimerinjectionInvestigationtoreplacethebiodistributiontest
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Monographs for Precursors for Radiopharmaceutical preparations
Challengesandconsiderations
- ImpossibletohavesoonaPh.Eur.monographforeachcurrentlyusedprecursor
Therefore GeneralMonograph“ChemicalPrecursorsforRadiopharmaceutical Preparations” hasbeenfinalizedinordertoprovideaself-containedguidanceintermsofqualitycriteriafortheseprecursorsubstances,takingintoaccounthowtheyareintendedtobeused
GeneralmonographonprecursorsforRPSomeparticularrequirements
Itisseen thattherequirementsforprecursorsforradiopharmaceuticalusearemorerelaxedthanthosefor‘substancesforpharmaceuticaluse’.
GeneralmonographonprecursorsforRPSomeparticularrequirements
These requirements are not repeated in individual monographs!4/15/16 Ph.Eur.ESRR2016Salzburg
THEFUTUREWorkprogram:Indium(111In)Pentetreotide,Fluoro-L-dopa(18F)(preparedbynucleophilicsubstitution)injection,Yttrium(90Y)Edotreotide,replacementoftheTBAtestinfluorine-18monographs,Betiatide(S-benzoyl-MAG3),Succimer(DMSA),Sodiumpyrophosphate,68Ga-PMSA
Potentially:
- PSMA-11andPSMA-617
- 68Gaproducedbycyclotron
Yourinputisvaluable:whatmonographsdoYOUneed?Pleaseletusknow!
4/15/16 Ph.Eur.ESRR2016Salzburg
Howcanyouhelpusmakingbettermonographs?
1) Ifyouareamanufacturerorcompoundforyourownuseanyoftheproductsthatweareworkingon,pleaseletusknowsowecaninviteyoutoworkwithGroup14/PRPgrouptoelaboratethemonographsanddoexperimentalverification
2) ProvideyourcommentsonthedraftspublishedinPharmeuropaOnline,freelyavailableonline:http://pharmeuropa.edqm.eu/home/
4/15/16 Ph.Eur.ESRR2016Salzburg