Designation:F2605−08´1StandardTestMethodforDeterminingtheMolarMassofSodiumAlginatebySizeExclusionChromatographywithMulti-angleLightScatteringDetection(SEC-MALS)1ThisstandardisissuedunderthefixeddesignationF2605;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginaladoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscriptepsilon(´)indicatesaneditorialchangesincethelastrevisionorreapproval.ε1NOTE—Subsection6.1.5waseditoriallycorrectedinSeptember2008.1.Scope1.1Thistestmethodcoversthedeterminationofthemolarmassofsodiumalginateintendedforuseinbiomedicalandpharmaceuticalapplicationsaswellasintissueengineeredmedicalproducts(TEMPs)bysizeexclusionchromatographywithmulti-anglelaserlightscatteringdetection(SEC-MALS).AguideforthecharacterizationofalginatehasbeenpublishedasGuideF2064.1.2AlginateusedinTEMPsshouldbewellcharacterized,includingthemolarmassandpolydispersity(molarmassdistribution)inordertoensureuniformityandcorrectfunc-tionalityinthefinalproduct.Thistestmethodwillassistendusersinchoosingthecorrectalginatefortheirparticularapplication.AlginatemayhaveutilityasascaffoldormatrixmaterialforTEMPs,incellandtissueencapsulationapplications,andindrugdeliveryformulations.1.3ThevaluesstatedinSIunitsaretoberegardedasstandard.Nootherunitsofmeasurementareincludedinthisstandard.1.4Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappro-priatesafetyandhealthpracticesanddeterminetheapplica-bilityofregulatorylimitationspriortouse.2.ReferencedDocuments2.1ASTMStandards:2F2064GuideforCharacterizationandTestingofAlginatesasStartingMaterialsIntendedforUseinBiomedicalandTissueEngineeredMedicalProductApplicationsF2315GuideforImmobilizationorEncapsulationofLivingCellsorTissueinAlginateGels2.2UnitedStatesPharmacopeia/NationalFormulary:3<621>Chromatography2.3NationalInstituteofStandardsandTechnology:4NISTSP811SpecialPublicati...
