Designation:F2313−10StandardSpecificationforPoly(glycolide)andPoly(glycolide-co-lactide)ResinsforSurgicalImplantswithMoleFractionsGreaterThanorEqualto70%Glycolide1ThisstandardisissuedunderthefixeddesignationF2313;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginaladoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscriptepsilon(´)indicatesaneditorialchangesincethelastrevisionorreapproval.1.Scope1.1Thisspecificationcoversbothvirginpoly(glycolide)homopolymerandpoly(glycolide-co-lactide)copolymerresinsintendedforuseinsurgicalimplants.Thepoly(glycolide-co-lactide)copolymerscoveredbythisspecificationpossessnominalmolefractionsgreaterthanorequalto70%glycolide(65.3%inmassfraction).Thisspecificationisalsoapplicabletolactide-co-glycolidecopolymersthatpossessglycolideseg-mentssufficientinsizetodeliverpotentialforglycolidebasedcrystallization,therebyrequiringfluorinatedsolventsforcom-pletedissolutionunderroomtemperatureconditions.1.2Sincepoly(glycolide)iscommonlyabbreviatedasPGAforpoly(glycolicacid)andpoly(lactide)iscommonlyabbre-viatedasPLAforpoly(lacticacid),thesepolymersarecom-monlyreferredtoasPGA,PLA,andPLA:PGAresinsforthehydrolyticbyproductstowhichtheyrespectivelydegrade.PLAisatermthatcarriesnostereoisomericspecificityandthereforeencompassesboththeamorphousatactic/syndiotacticDL-lactide-basedpolymersandcopolymersaswellastheisotacticD-PLAandL-PLAmoieties,eachofwhichcarriespotentialforcrystallization.1.3Thisspecificationisspecificallynotapplicabletoamor-phouspoly(lactide-co-glycolide)orpoly(lactide)-basedresinsabletobefullysolvatedat30°Cbyeithermethylenechloride(dichloromethane)orchloroform(trichloromethane),whicharecoveredinSpecificationF2579andtypicallypossessmolarglycolidelevelsof~50%orless.Thisspecificationisnotapplicabletolactide-basedpolymersorcopolymersthatpos-sessisotacticpolymericsegmentssufficientinsizetocarrypotentialforlactide-basedcrystallization,whicharecoveredbySpecificationF1...
