USP美国药典1504 英文版化学合成法多肽原料药起始物料的质量属性QUALITY ATTRIBUTES OF STARTING MATERIALS FOR THE CHEMICAL SYNTHESIS OF THERAPEUTIC PEPTIDES.docx

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USP美国药典1504 英文版化学合成法多肽原料药起始物料的质量属性QUALITY ATTRIBUTES OF STARTING MATERIALS FOR THE CHEMICAL SYNTHESIS OF THERAPEUTIC PEPTIDES.docx

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Status:NotYetOfficialon01-Aug-2023

OfficialDate:01-Dec-2023

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DocId:GUID-06A07B0B-3865-40B6-A4C9-D77B5DAD0B3B_2_en-US

DocumentType:GENERALCHAPTER

DOI:/10.31003/USPNF_M16255_02_01

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▲〈1504〉QUALITYATTRIBUTESOFSTARTINGMATERIALSFORTHECHEMICALSYNTHESISOFTHERAPEUTICPEPTIDES

SCOPE

Thisgeneralchapterisintendedtoproviderecommendationsontheminimumqualityattributesforstartingmaterialsusedinthemanufactureofsynthetictherapeuticpeptides.Becauseitisnotpossibletocoverthewidevarietyofavailablestartingmaterialsthatmaybeused,includingaminoacids,protectedaminoacidderivatives,andpeptidefragments,thediscussioninthischapterwillbelimitedtothemostcommonlyusedprotectedaminoacidderivatives(AAD),i.e.,9-fluorenylmethyloxycarbonyl(Fmoc)aminoacidderivatives(includingresin-boundAAD).However,itisintendedthatthegeneralconceptsandguidanceprovidedforthisclassofstartingmaterialsshouldbeappliedtoallpeptidestartingmaterials,whereapplicable.ThischapteristobeusedinconjunctionwithQualityAttributesofSyntheticPeptideDrugSubstances〈1503〉.

INTRODUCTION

Theincreasedinterestinpeptidesasdrugcandidatesduringthepastfewdecadescanbeattributedtoanumberoffactors,includingadvancesinproteomicsandhigh-throughputscreeningtechniques,whichhaveacceleratedthedevelopmentofnewpotentialtherapeuticcandidates.Furthermore,thedevelopmentofefficientsyntheticchemicalstrategies,combinedwithrobustpurificationprocessesandmorepowerfulanddiscriminatinganalyticalmethodologies,havefacilitatedthemanufactureofpeptideswithhigh-qualitystandards.The