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Printedon:TueAug302022,10:01:32am
Printedby:AlbertZhao
Status:CurrentlyOfficialon30-Aug-2022
OfficialDate:Officialasof01-Aug-2021
DocumentType:GENERALCHAPTER
DocId:GUID-36322BA3-3F12-4A80-9020-156D7EEBFB89_2_en-US
DOI:/10.31003/USPNF_M12935_02_01
DOIRef:r9xxs
?2022USPC
Addthefollowing:
▲〈1503〉QUALITYATTRIBUTESOFSYNTHETICPEPTIDEDRUGSUBSTANCES
INTRODUCTION
PEPTIDEDEFINITION
MANUFACTURINGMETHODS
RAWMATERIALS
PEPTIDEGENERALCHARACTERISTICSANDSPECIFICATION
ColorandAppearance
Identification
Bioassays
AssayandPeptideContent
Impurities
MicrobiologicalContamination
BacterialEndotoxins
SpecificTests
INTRODUCTION
Thepharmaceuticalindustry’sinterestinpeptidesasdrugcandidates—basedontheirpotency,enormousfunctionaldiversity,highdegreeofspecificity,andgenerallackoftoxicity—hasexistedsincetheirgeneralstructurewasfirstelucidatedmorethan100yearsago.Theearlydevelopmentofsyntheticpeptidesfortherapeuticusewas,however,challengedbythehighcostsofproduction,theirinherentlyshortin-vivohalf-lives,thelackofsensitiveanddiscriminatinganalyticalmethodsforintermediates,andtherelativelycomplexmanufacturingmethods,whicharenowreferredtoas“solutionpeptidesynthesis”or“liquid-phasepeptidesynthesis”(LPPS).
Theintroductionofsolid-phasepeptidesynthesis(SPPS)wasakeyfactorinfacilitatingtheexpansionofpeptideresearchandmadetheproductionofpeptideswithsequenceslongerthan20aminoacidsfeasible.Also,inrecentyears,newformulationsandconjugationstrategieshaveresultedinalternativeroutesofadministrationandlongerhalf-livesforpeptidetherapeutics,whichhavefacilitatedpatientcompliance.Asaresult,morepeptidedrugshavebeenapprovedandareinclinicaldevelopment.Inspiteofthesesuccesses—orperhapsbecauseofthem—somechallengesinpeptidemanufacturingremain,especiallywiththeincreasing
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