USP30_1231-WATER FOR PHARMACEUTICAL PURPOSES翻译(节选)

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1、USP30--<1231>WATERFORPHARMACEUTICALPURPOSESUSP30<1231>制药用水（节选饮用水部分）SOURCEORFEEDWATERCONSIDERATIONS水源或供水系统Toensureadherencetocertainminimalchemicalandmicrobiologicalqualitystandards,waterusedintheproductionofdrugsubstancesorassourceorfeedwaterforthepreparationofthevarioustypesofpurifiedwatersmustme

2、ettherequirementsoftheNationalPrimaryDrinkingWaterRegulations(NPDWR)(40CFR141)issuedbytheU.S.EnvironmentalProtectionAgency(EPA)orthedrinkingwaterregulationsoftheEuropeanUnionorJapan,ortheWHOdrinkingwaterguidelines.为了保证能达到某些化学和微生物的最低质量标准，用于药品生产的水或者是用于制备各种纯化水的水源必须要符合美国环境保护局（EPA）发布的国家基本饮用水规定（NPDWR）(4

3、0CFR141)。欧盟、日本或WHO的有关饮用水规定也可适用。Limitsonthetypesandquantitiesofcertainorganicandinorganiccontaminantsensurethatthewaterwillcontainonlysmall,safequantitiesofpotentiallyobjectionablechemicalspecies.Therefore,waterpretreatmentsystemswillonlybechallengedtoremovesmallquantitiesofthesepotentiallydifficul

4、t-to-removechemicals.Also,controlofobjectionablechemicalcontaminantsatthesource-waterstageeliminatestheneedtospecificallytestforsomeofthem(e.g.,trihalomethanesandheavymetals)afterthewaterhasbeenfurtherpurified.对某些有机和无机污染物的种类和数量进行限定可以保证水中只含有微小的，可靠数量的潜在的化学物质。因此水的预处理系统只需除掉这些少量的、难以去除的化学物质。而且，从水源开始对这些令

5、人讨厌的化学污染物进行控制就可以免去在后续纯化过程中对这些化学物质（如：三卤代甲烷和重金属）的检验。Microbiologicalrequirementsofdrinkingwaterensuretheabsenceofcoliforms,which,ifdeterminedtobeoffecalorigin,mayindicatethepotentialpresenceofotherpotentiallypathogenicmicroorganismsandvirusesoffecalorigin.饮用水规定中的微生物标准保证了水中不存在大肠菌群。如经确定该菌来自粪便，则预示可能有来自粪

6、便的其他病原微生物和病毒。Meetingthesemicrobiologicalrequirementsdoesnotruleoutthepresenceofothermicroorganisms,whichcouldbeconsideredundesirableiffoundinadrugsubstanceorformulatedproduct.符合国家饮用水的微生物标准并不排除有其他微生物的存在。同时人们也不希望这些微生物出现在基质药物和配方产品中。Toaccomplishmicrobialcontrol,MunicipalWaterAuthoritiesadddisinfectant

7、stodrinkingwater.Chlorine-containingandotheroxidizingsubstanceshavebeenusedformanydecadesforthispurposeandhavegenerallybeenconsideredtoberelativelyinnocuoustohumans.为控制微生物，地方水务局在饮用水中加入消毒剂。公认的对人体无害的含氯消毒剂和其它氧化性消毒剂被