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USP38-通用章节指导目录(附录)第1页共12页GuidetoGeneralChapters通用章节指导GeneralRequirementsforTestandAssays检查与含量分析的一般要求＜1＞INJECTIONSANDIMPLANTEDDRUGPRODUCTS(PARENTERALS)—PRODUCTQUALITYTESTS注射和植入药物产品(注射用)—产品质量测试＜1＞INJECTIONS注射剂＜2＞ORALDRUGPRODUCTS—PRODUCTQUALITYTESTS口服药物产品质量测试＜3＞TOPICALANDTRANSDERMALDRUGPRODUCTS—PRODUCTQUALITYTESTS局部和透皮药物产品—产品质量测试＜4＞MUCOSALDRUGPRODUCTS—PRODUCTQUALITYTESTS粘膜药物产品质量测试＜5＞INHALATIONANDNASALDRUGPRODUCTS—GENERALINFORMATIONANDPRODUCTQUALITYTESTS吸入剂产品—产品质量测试＜7＞LABELING标签＜11＞USPREFERENCESTANDARDSUSP标准品ApparatusforTestandAssays用于检查与含量分析的器具＜17＞PRESCRIPTIONCONTAINERLABELING处方容器标签＜21＞THERMOMETERS温度计＜31＞VOLUMETRICAPPARATUS容量器具＜41＞BALANCES天平MicrobiologicalTests微生物检查法＜51＞ANTIMICROBIALEFFECTIVENESSTESTING抗菌剂有效性检查法＜55＞BIOLOGICALINDICATORS—RESISTANCEPERFORMANCETESTS生物指示剂－耐药性实验＜61＞MICROBIOLOGICALEXAMINATIONOFNONSTERILEPRODUCTS:MICROBIALENUMERATIONTESTS非无菌产品的微生物限度检查：微生物列举检查法＜62＞MICROBIOLOGICALEXAMINATIONOFNONSTERILEPRODUCTS:TESTSFORSPECIFIEDMICROORGANISMS非无菌产品的微生物限度检查：特定微生物检查法＜63＞MYCOPLASMATESTS支原体检查法＜71＞STERILITYTESTS无菌检查法Biologicaltestsandassays生物检查法与测定法＜81＞ANTIBIOTICS—MICROBIALASSAYS抗生素－微生物测定＜85＞BACTERIALENDOTOXINSTEST细菌内毒素检查法＜87＞BIOLOGICALREACTIVITYTESTS,INVITRO体外的生物反应性检查法＜88＞BIOLOGICALREACTIVITYTESTS,INVIVO体内的生物反应性检查法＜89＞ENZYMESUSEDASANCILLARYMATERIALSINPHARMACEUTICALMANUFACTURINGUSP38-通用章节指导目录(附录)第2页共12页2药品生产中酶作为辅料所使用＜90＞FETALBOVINESERUM—QUALITYATTRIBUTESANDFUNCTIONALITYTESTS牛胎儿血清-质量品质和功能检查法＜91＞CALCIUMPANTOTHENATEASSAY泛酸钙测定法＜92＞GROWTHFACTORSANDCYTOKINESUSEDINCELLTHERAPYMANUFACTURING在细胞疗法中使用生长因子和细胞因子＜111＞DESIGNANDANALYSISOFBIOLOGICALASSAYS生物测定法的设计与分析＜115＞DEXPANTHENOLASSAY右泛醇（拟胆碱药）测定法＜121＞INSULINASSAYS胰岛素测定法＜121.1＞PHYSICOCHEMICALANALYTICALPROCEDURESFORINSULINS胰岛素的物理化学分析程序＜123＞GLUCAGONBIOIDENTITYTESTS高血糖素的生物鉴别检查法＜124＞ERYTHROPOIETINBIOASSAYS红细胞生成素的微生物测定＜126＞SOMATROPINBIOIDENTITYTESTS生长激素的生物鉴别检查法＜130＞PROTEINAQUALITYATTRIBUTES蛋白质A的质量特征＜151＞PYROGENTEST热原检查法＜161＞TRANSFUSIONANDINFUSIONASSEMBLIESANDSIMILARMEDICALDEVICES输血输液用具以及相类似的医疗器械＜171＞VITAMINB12ACTIVITYASSAY……2548维生素B12活性测定法ChemicalTestsandassays化学实验检查与测定法鉴别检查＜181＞IDENTIFICATION—ORGANICNITROGENOUSBASES鉴别－有机氮碱化合物＜191＞IDENTIFICATIONTESTS—GENERAL鉴别实验－通用＜193＞IDENTIFICATION—TETRACYCLINES鉴别－四环素类＜197＞SPECTROPHOTOMETRICIDENTIFICATIONTESTS分光光度计鉴别实验＜201＞THIN-LAYERCHROMATOGRAPHICIDENTIFICATIONTEST薄层色谱鉴别实验LimitTests限度检查法＜206＞ALUMINUM铝＜207＞TESTFOR1,6-ANHYDRODERIVATIVEFORENOXAPARINSODIUM依诺肝素钠的酐类衍生物实验＜208＞ANTI-FACTORXaANDANTI-FACTORIIaASSAYSFORUNFRACTIONATEDANDLOWMOLECULARWEIGHTHEPARINS普通肝素和低分子肝素产品中抗体Xa和抗体IIa测定＜209＞LOWMOLECULARWEIGHTHEPARINMOLECULARWEIGHTDETERMINATIONS低分子肝素钠分子量测定＜211＞ARSENIC砷USP38-通用章节指导目录(附录)第3页共12页3＜221＞CHLORIDEANDSULFATE氯和硫＜223＞DIMETHYLANILINE二甲基苯胺＜226＞4-EPIANHYDRO-TETRACYCLINE4－？－四环素＜227＞4-AMINOPHENOLINACETAMINOPHEN-CONTAININGDRUGPRODUCTS对乙酰氨酚药物产品中氨基酚＜228＞ETHYLENEOXIDEANDDIOXANE环氧乙烷和二氧六环＜231＞HEAVYMETALS重金属（删除）＜232＞ELEMENTALIMPURITIES—LIMITS元素杂质-限度＜233＞ELEMENTALIMPURITIES—PROCEDURES元素杂质-规程＜241＞IRON铁＜251＞LEAD铅＜261＞MERCURY汞＜267＞POROSIMETRYBYMERCURYINTRUSION水银孔隙仪＜268＞POROSITYBYNITROGENADSORPTION–DESORPTION氮吸附-解吸测定孔隙率＜271＞READILYCARBONIZABLESUBSTANCESTEST易碳化物检查法＜281＞RESIDUEONIGNITION炽灼残渣＜291＞SELENIUM硒OtherTestsandAssays其它检查法与测定法＜301＞ACID-NEUTRALIZINGCAPACITY酸中和容量＜311＞ALGINATESASSAY藻酸盐测定法＜341＞ANTIMICROBIALAGENTS—CONTENT抗菌剂－含量＜345＞AssayforCitricAcid/CitrateandPhosphate柠檬酸/柠檬酸盐和磷酸盐的测定＜351＞ASSAYFORSTEROIDS类固醇（甾类化合物）测定法＜361BARBITURATEASSAY巴比妥类药物测定法＜371＞COBALAMINRADIOTRACERASSAY钴铵素放射性跟踪剂测定法＜381＞ELASTOMERICCLOSURESFORINJECTIONS注射剂的弹性密封件＜391＞EPINEPHRINEASSAY肾上腺素测定法＜401＞FATSANDFIXEDOILS脂肪与混合油＜411＞FOLICACIDASSAY叶酸测定法＜413＞IMPURITIESTESTINGINMEDICALGASES医用气体杂质检查＜415＞MEDICALGASESASSAY医用气体含量检查＜425＞IODOMETRICASSAY—ANTIBIOTICS碘量检查法－抗生素＜429＞LIGHTDIFFRACTIONMEASUREMENTOFPARTICLESIZE粒径的光衍射测量法＜431＞METHOXYDETERMINATION甲氧基测定法＜441＞NIACINORNIACINAMIDEASSAY烟酰或烟酰胺测定法＜451＞NITRITETITRATION亚硝酸盐滴定USP38-通用章节指导目录(附录)第4页共12页4＜461＞NITROGENDETERMINATION氮测定法＜466＞ORDINARYIMPURITIES一般杂质＜467＞RESIDUALSOLVENTS残留溶剂＜469＞ETHYLENEGLYCOL,DIETHYLENEGLYCOL,ANDTRIETHYLENEGLYCOLINETHOXYLATEDSUBSTANCES乙氧基物质中乙二醇、二甘醇、三甘醇测定＜471＞OXYGENFLASKCOMBUSTION氧瓶燃烧法＜481＞RIBOFLAVINASSAY核黄素（维生素B2）测定法＜501＞SALTSOFORGANICNITROGENOUSBASES有机氮盐＜503＞ACETICACIDINPEPTIDES多肽类中乙酸测定＜511＞SINGLE-STEROIDASSAY单一的类固醇测定法＜525＞SULFURDIOXIDE二氧化硫＜531＞THIAMINEASSAY硫胺素测定法＜541＞TITRIMETRY滴定法＜551＞VITAMINEASSAY维生素E测定法＜561＞ARTICLESOFBOTANICALORIGIN植物起源的药品＜563＞IDENTIFICATIONOFARTICLESOFBOTANICALORIGIN植物药品的鉴别＜565＞BOTANICALEXTRACTS植物提取＜571＞VITAMINAASSAY维生素A测定法＜581＞VITAMINDASSAY维生素D测定法＜591＞ZINCDETERMINATION锌的测定法PhysicalTestandDeterminations物理检查与测定法＜601＞INHALATIONANDNASALDRUGPRODUCTS:AEROSOLS,SPRAYS,ANDPOWDERS—PERFORMANCEQUALITYTESTS吸入剂、鼻雾剂：气溶胶，喷雾，干粉-质量通则＜602＞PROPELLANTS推进剂＜603＞TOPICALAEROSOLS局部喷雾剂＜604＞LEAKRATE渗漏率＜610＞ALTERNATIVEMICROBIOLOGICALSAMPLINGMETHODSFORNONSTERILEINHALEDANDNASALPRODUCTS非无菌吸入和鼻雾剂可供选择的微生物取样方法＜611＞ALCOHOLDETERMINATION乙醇测定法＜616＞BULKDENSITYANDTAPPEDDENSITY堆密度与振实密度＜621＞CHROMATOGRAPHY色谱法＜631＞COLORANDACHROMICITY呈色与消色＜641＞COMPLETENESSOFSOLUTION溶解度＜643＞TOTALORGANICCARBON总有机碳USP38-通用章节指导目录(附录)第5页共12页5＜645＞WATERCONDUCTIVITY水电导率＜651＞CONGEALINGTEMPERAT