USP氯化钠译文VIP免费

SodiumChloride氯化钠NaCl58.44SodiumChlorideSodiumChloride[7647-14-5].»SodiumChloridecontainsnotlessthan99.0percentandnotmorethan100.5percentofNaCl,calculatedonthedriedbasis.氯化钠按干燥品计算，含氯化钠应不少于99%不高于100.5%。Packagingandstorage—Preserveinwell-closedcontainers.包装与贮藏：密封保存。Labeling—WhereSodiumChlorideisintendedforuseinthemanufactureofinjectabledosageforms,peritonealdialysissolutions,hemodialysissolutions,orhemofiltrationsolutions,itissolabeled.WhereSodiumChloridemustbesubjectedtofurtherprocessingduringthepreparationofinjectabledosageformstoensureacceptablelevelsofBacterialendotoxins,itissolabeled.WhereSodiumChlorideissterile,itissolabeled.以下情况均需注明：氯化钠应用于注射剂、腹膜透析溶液、血液透析液和血液过滤液的生产；氯化钠经过进一步加工应用于注射剂型时的细菌内毒素可接受水平；无菌情况。Appearanceofsolution—Dissolve20.0gofSodiumChlorideincarbondioxide-freewater,anddilutewiththesamesolventto100.0mL.Thissolutionisclearandcolorless.溶液性状：将本品20.0g溶解于去二氧化碳水中，定容至100.0ml，溶液应澄清无色。Identification—ItrespondstothetestsforSodium191andforChloride.鉴别：应与钠盐和氯化物鉴别一致。Chloride—Dissolveabout3mgofSodiumChloridein2mLofwater.Acidifywithdilutednitricacidandadd0.4mLofsilvernitrateTS.Shake,andallowtostand.Acurdled,whiteprecipitateisformed.Centrifuge,washtheprecipitatewiththree1-mLportionsofwater,anddiscardthewashings.Carryoutthisoperationrapidlyinsubduedlight,disregardingthefactthatthesupernatantmaynotbecomeperfectlyclear.Suspendtheprecipitatein2mLofwaterandadd1.5mLof10Nammoniumhydroxide.Theprecipitatedissolveseasilywiththepossibleexceptionofafewlargeparticles,whichdissolvemoreslowly.氯化物：将本品3mg溶解于2ml水中，用适量稀硝酸酸化后，加入0.4ml硝酸银试液，振摇，静置，离心，弃去上清液，沉淀用1ml水分3次洗涤，弃去洗涤剂（洗涤液如有浑浊可不计）。加入2ml水将沉淀悬浮，再加入1.5ml10N的氨水，沉淀迅速溶解，大块的沉淀物溶解较为缓慢。此操作应快速且避光。Bacterialendotoxins85—ThelevelofBacterialendotoxinsaresuchthattherequirementundertherelevantdosageformmonograph(s)inwhichSodiumChlorideisusedcanbemet.WherethelabelstatesthatSodiumChloridemustbesubjectedtofurtherprocessingduringthepreparationofinjectabledosageforms,thelevelofBacterialendotoxinsaresuchthattherequirementundertherelevantdosageformmonograph(s)inwhichSodiumChlorideisusedcanbemet.细菌内毒素：细菌内毒素水平应参照氯化钠的应用剂型要求。经加工应用于注射剂的氯化钠，应符合相关剂型专著的要求。Sterility71—WherethelabelstatesthatSodiumChlorideissterile,itmeetstherequirementsforSterilityundertherelevantdosageformmonograph(s)inwhichSodiumChlorideisused.无菌：应符合相应剂型的无菌要求。Acidityoralkalinity—To20mLofthesolutionpreparedforthetestforAppearanceofsolution,add0.1mLofbromothymolblueTS:notmorethan0.5mLof0.01Nhydrochloricacidor0.01Nsodiumhydroxideisrequiredtochangethecolorofthissolution.酸碱度：取20ml溶液性状项下溶液，加入0.1ml麝香草芬兰试液，加入至多0.5ml0.01N盐酸溶液或0.01N氢氧化钠溶液，溶液颜色均应改变。（参照中国药典2010版）Lossondrying731—Drythetestmaterialat105ºfor2hours:itlosesnotmorethan0.5%ofitsweight,determinedona1.000gsample.干燥失重：精密称取本品约1g在105℃干燥2小时，减失重量不得过0.5%。Limitofbromides—To0.5mLofthesolutionpreparedforthetestforAppearanceofsolution,add4.0mLofwater,2.0mLofpH4.7phenolredTS,and1.0mLofchloramineTsolution(0.1mgpermL),andmiximmediatel...