欧洲药典7.4索引(现行版)(4)

欧洲药典7.4索引(现行版)

EUROPEANPHARMACOPOEIA/forum.php?mod=viewthread&tid=21456&fromuid=1023 7.4

Index

2.9.32.3.2.8.porosimetry.....................................................................................299Porosityandpore-sizedistributionofsolidsbymercury3.2.9.SterileRubbersingle-useclosuresforplasticcontainerssyringes.....................................373foraqueous2.9.33.parenteral

2.9.34.solidsCharacterisationbyBulkX-rayofcrystallineandpartiallycrystalline

densitypowderanddiffractiontappeddensity(XRPD)...............................ofpowders...............3053013.2.freeze-driedpreparations,

Containers.................................................................................363powders.....................................................................forpowdersandfor374

2.9.35.3-2.9.36.Powderfineness.................................................................3084.1.1.O-Desacyl-4′-monophosphoryllipidA.............................7.2-3639

2.9.36.PowderPowderflow.........................................................................308flow(5.8.).....................................................7.1-33474.1.2.Reagents........................................................................Standardsolutionsforlimittests.............................7.47.4-4109-42162.9.37.2.9.37.Optical4.1.3.

2.9.38.Opticalmicroscopy..............................................................311

Particle-sizemicroscopydistribution(5.8.).........................................estimationbyanalytical7.1-33474.1.Buffer

4.2.1.Reagents,solutions...........................................................

Primarystandardstandardssolutions,forvolumetricbuffersolutions..........solutions........7.4

7.47.4-4220

-4225-4109

2.9.38.sieving..............................................................................................4.2.2.

(5.8.).........................................................................................Particle-sizedistributionestimationbyanalytical313

7.1sieving-33474.2.4-AminobenzoicVolumetricVolumetricanalysis.........................................................solutions...................................................7.4-4225

acid.....................................................................13717.4-4225

2.9.39.4.

2.9.3.sorption-desorptionWater-solidinteractions:

Dissolutiontestisothermsforsoliddosageanddeterminationofwaterforms..................activity....of7.17.3-3335-37975.10.Reagents...............................................................................

use............................................................................................Controlofimpuritiesinsubstancesforpharmaceutical7.4-4109

7.4-42472.9.40.2.9.41.Uniformityofdosageunits......................................5.1.10.

2.9.42.FriabilityDissolutionofgranules7.4-4101

testforlipophilicandspheroids.....................soliddosageforms.......7.4-41033195.11.Guidelinesforusingthetestfor

5.1.1.CharactersMethodsofsectionpreparationinmonographs....................................637bacterialendotoxins..520

ofsterileproducts....................5032.9.43.2.9.44.Apparent5.1.2.

3803Preparationsdissolution.........................................................320fornebulisation:characterisation.........7.3-5.12.Biologicalindicatorsofsterilisation.................................504

5.1.3.ReferenceEfficacyofstandards..............................................................antimicrobialpreservation.............................505641

2.9.45.2.9.4.Wettabilityofporoussolidsincludingpowders..........3215.14.

2.9.5.DissolutionUniformityoftestmassforoftransdermalsingle-dosepatches........................263preparations.............2655.1.4.Gene

preparationsMicrobiologicaltransfermedicinal

andsubstancesqualityproductsofforhumanuse..........647

fornon-sterilepharmaceuticalpharmaceuticaluse...........5072.9.6.2.9.7.Uniformityofcontentofsingle-dosepreparations........2665.1.4.

2.9.7.FriabilityFriabilityofofuncoateduncoatedtablets.............................................266tablets(5.8.)..........................7.1-3346preparationsMicrobiologicalqualityof

(5.8.).........................................................................................andsubstancesfornon-sterilepharmaceuticalpharmaceuticaluse7.1-33472.9.8.2.9.9.Resistancetocrushingoftablets......................................2675.1.5.ApplicationoftheF0concepttosteam

2.9.PharmaceuticalMeasurementoftechnicalconsistencyprocedures.................................253bypenetrometry..............267

3.1.10.Materialsbasedon5.15.aqueoussterilisationof

Functionality-relatedpreparations...................................................................508characteristicsofexcipients.........6615.1.6.Alternativemethodsforcontrolof

3.1.11.forcontainersMaterialsforbasednon-injectable,non-plasticisedpoly(vinylchloride)

onnon-plasticisedaqueouspoly(vinylsolutions............349chloride)for5.16.quality...............................................................................................508microbiological

Crystallinity....................................................................7.4-4253

3.1.1.1.containers5.17.1.

containersMaterialsfordrydosageformsfororaladministration......350

forhumanbasedbloodonplasticisedandbloodpoly(vinylcomponents.............329chloride)for5.17.

3.1.1.2.testing...............................................................................................665RecommendationsRecommendationsononmethodsdissolutionfortesting.....................665dosageformstubingMaterials5.1.7.

components.....................................................................................332usedinsetsbasedforonthepl …… 此处隐藏：5879字，全部文档内容请下载后查看。喜欢就下载吧 ……