Designation:F2602−13StandardTestMethodforDeterminingtheMolarMassofChitosanandChitosanSaltsbySizeExclusionChromatographywithMulti-angleLightScatteringDetection(SEC-MALS)1ThisstandardisissuedunderthefixeddesignationF2602;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginaladoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscriptepsilon(´)indicatesaneditorialchangesincethelastrevisionorreapproval.1.Scope1.1Thistestmethodcoversthedeterminationofthemolarmassofchitosanandchitosansaltsintendedforuseinbiomedicalandpharmaceuticalapplicationsaswellasintissueengineeredmedicalproducts(TEMPs)bysizeexclusionchro-matographywithmulti-anglelaserlightscatteringdetection(SEC-MALS).AguideforthecharacterizationofchitosansaltshasbeenpublishedasGuideF2103.1.2ChitosanandchitosansaltsusedinTEMPsshouldbewellcharacterized,includingthemolarmassandpolydisper-sity(molarmassdistribution)inordertoensureuniformityandcorrectfunctionalityinthefinalproduct.Thistestmethodwillassistendusersinchoosingthecorrectchitosanfortheirparticularapplication.ChitosanmayhaveutilityasascaffoldormatrixmaterialforTEMPs,incellandtissueencapsulationapplications,andindrugdeliveryformulations.1.3ThevaluesstatedinSIunitsaretoberegardedasstandard.Nootherunitsofmeasurementareincludedinthisstandard.1.4Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappro-priatesafetyandhealthpracticesanddeterminetheapplica-bilityofregulatorylimitationspriortouse.2.ReferencedDocuments2.1ASTMStandards:2F2103GuideforCharacterizationandTestingofChitosanSaltsasStartingMaterialsIntendedforUseinBiomedicalandTissue-EngineeredMedicalProductApplications2.2UnitedStatesPharmacopeia/NationalFormulary:3<621>Chromatography2.3NationalInstituteofStandardsandTechnology:4NISTSP811SpecialPublication:GuidefortheUseoftheInternationalSystemofUnits(SI)3.Terminology3.1Definitions:3.1.1chitosan,n...
