Designation:D7077–04StandardTestMethodforEvaluationofDropSizebyweightofSolutionsandSuspensions1ThisstandardisissuedunderthefixeddesignationD7077;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginaladoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscriptepsilon(e)indicatesaneditorialchangesincethelastrevisionorreapproval.1.Scope1.1Thisstandardtestmethodusesasimulatedin-usestudytomeasurethedropsizebyweightandtodeterminethenumberofdropspercontainerforsolutionsandsuspensionscontainedinapackagesystemdesignedtodeliverproductdrop-wisethroughacontrolledsizeorificebysqueezingorcompressingthepackage.1.2Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappro-priatesafetyandhealthpracticesandtodeterminetheapplicabilityofregulatorylimitationspriortouse.2.Terminology2.1Definitions:2.1.1Averagedropsizeperdosinginterval—Theaverageweightofadropofproductdispensedfromagivenpackagewithinagivendosinginterval.2.1.2Averagedropsizeperpackage—Theaverageweightofadropofproductdispensedfromagivenpackageconsid-eringalldispenseddoses.2.1.3Controllingorifice—Adispensingplugwhichfitssnugglyenoughinthematingbottletoformaseal,therebyforcingallfluidexitingthepackagetotravelthroughtheplug.2.1.4Dosinginterval—Thetimeperiodbetweenproductdosings.Testingmaybeperformed“asperlabeldirections,”whichmeanstestingisperformedattimeintervalsdefinedbylabeldirections(forexample,oncedaily).Alternatively,testingmaybeperformed“continuously,”meaningthatashortertimeperiodbetweendosingintervalsisusedinordertoexpeditetesting.2.1.5Dropsize—Theweightofasingledropofproductdispensedfromapackagedesignedtodeliverproductthroughacontrollingorifice.2.1.6Unsoliciteddrops—Anamountofproductthatcomesfromthecontainerwithouttheusersqueezingthecontainer.2.1.7Variable—Differentplugs,closures,bottles,orformu-lations.2.1.8Volcanoing—Spewingforthoftheproductupo...
