Designation:F2579−10StandardSpecificationforAmorphousPoly(lactide)andPoly(lactide-co-glycolide)ResinsforSurgicalImplants1ThisstandardisissuedunderthefixeddesignationF2579;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginaladoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscriptepsilon(´)indicatesaneditorialchangesincethelastrevisionorreapproval.1.Scope1.1Thisspecificationcoversvirginamorphouspoly(lactide)homopolymerandpoly(lactide-co-glycolide)copolymerresinsintendedforuseinsurgicalimplants.Thepoly(DL-lactide)homopolymerscoveredbythisspecificationareconsideredtobeamorphous(thatis,voidofcrystallinity)andarepolymer-izedeitherfrommeso-lactideorfromequimolar(racemic)combinationsofD-lactideandL-lactide.Thepoly(DL-lactide-co-glycolide)copolymerscoveredbythisspecificationarealsoconsideredtobeamorphousandareco-polymerizedfromacombinationofglycolideandeithermeso-lactideorracemicquantitiesofD-lactideandL-lactide,andtypicallypossessnominalmolefractionsthatequalorexceed50%lactide.1.2Sincepoly(glycolide)iscommonlyabbreviatedasPGAforpoly(glycolicacid)andpoly(lactide)iscommonlyabbre-viatedasPLAforpoly(lacticacid),thesepolymersarecom-monlyreferredtoasPGA,PLA,andPLA:PGAresinsforthehydrolyticbyproductstowhichtheyrespectivelydegrade.PLAisatermthatcarriesnostereoisomericspecificityandthereforeencompassesboththeamorphousatactic/syndiotacticDL-lactide-basedpolymersandcopolymersaswellastheisotacticD-PLAandL-PLAmoieties,eachofwhichcarriespotentialforcrystallization.Therefore,specificreferencetoDL-PLAisessentialtoappropriatelydifferentiatetheamorphousatactic/syndiotacticDL-lactide-basedpolymersandcopolymerscov-eredbythisspecification.Thus,inclusionofstereoisomericspecificitywithinthelacticacid-basedacronymsresultsinthefollowing:poly(L-lactide)asPLLAforpoly(L-lacticacid),poly(D-lactide)asPDLAforpoly(D-lacticacid),andpoly(DL-lactide)asPDLLAforpoly(DL-lacticacid).1.3Thisspecificationcoversvirginamorphouspoly(l...
