EuropeanPharmacopoeia

NewmonographsandchaptersintheEuropeanPharmacopoeia

EuropeanPharmacopoeiaOrganisation

• TheEuropeanPharmacopoeia containsalargenumberofmonographs,amongthemabout70onradiolabelled radio-pharmaceuticalsandradioactiveprecursorsand5onnon-radioactiveprecursorsforradiosynthesis.

• Dr.EllenPelhaspresentedonhowtouseandhowtocontributetotheEuropeanPharmacopoeia.

• TheEuropeanPharmacopoeiahascurrentlythreegroupsworkingintheareaofradiopharmaceuticals:- ExpertGroup14(RadioactiveCompounds)

- PRPworkingParty(Precursorsforradiopharmaceuticalpreparations)

- CRPworkingParty(Productionandcompoundingofradiopharmaceuticalpreparations)

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MONOGRAPHS

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New/changedmonographspublished since2014(Ed8.2)

Fludeoxyglucose(18F)injectionAcorrectionwasmadetothetestforchemicalpuritytohaveabettersystemsuitabilitytest

Technetium(99mTc)etifenininjectionThebiodistributiontestwasdeletedasanimprovedidentityandRCPtestwasintroducedwhichisinlinewiththe3Rpolicy(Replacement,ReductionandRefinementofanimaltesting).

Fluoroethyl-l-tyrosine(18F)injectionNewmonograph

Coppertetramibitetrafluoroborateforradiopharmaceuticalpreparations

Newmonograph

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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

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GeneralmonographonprecursorsforRPSomeparticularrequirements

Itisseen thattherequirementsforprecursorsforradiopharmaceuticalusearemorerelaxedthanthosefor‘substancesforpharmaceuticaluse’.

GeneralmonographonprecursorsforRPSomeparticularrequirements

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!

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Howcanyouhelpusmakingbettermonographs?

1) Ifyouareamanufacturerorcompoundforyourownuseanyoftheproductsthatweareworkingon,pleaseletusknowsowecaninviteyoutoworkwithGroup14/PRPgrouptoelaboratethemonographsanddoexperimentalverification

2) ProvideyourcommentsonthedraftspublishedinPharmeuropaOnline,freelyavailableonline:http://pharmeuropa.edqm.eu/home/

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THANKYOU

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