欧洲药典7.0中胶塞部分

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1、3.2.9.RubberclosuresforcontainersEUROPEANPHARMACOPOEIA7.0Siliconeoil.Calculatetheinternalsurfaceareaofasyringein01/2008:30209squarecentimetresusingthefollowingexpression:corrected7.03.2.9.RUBBERCLOSURESFORV=nominalvolumeofthesyringe,incubiccentimetres;CONTAINERSFORAQUEOUSh=heigh

2、tofthegraduation,incentimetres.PARENTERALPREPARATIONS,TakeasufficientnumberofsyringestogiveaninternalsurfaceFORPOWDERSANDFORareaof100cm2to200cm2.AspirateintoeachsyringeaFREEZE-DRIEDPOWDERSvolumeofmethylenechlorideRequaltohalfthenominalvolumeandmakeuptothenominalvolumewithair.Rin

3、setheRubberclosuresforcontainersforaqueousparenteralinternalsurfacecorrespondingtothenominalvolumewiththepreparationsforpowdersandforfreeze-driedpowdersaresolventbyinvertingthesyringetentimesinsuccessionwithmadeofmaterialsobtainedbyvulcanisation(cross-linking)theneedlefittingclo

4、sedbyafingercoveredbyaplasticfilmofmacromolecularorganicsubstances(elastomers),withinerttomethylenechloride.Expeltheextractsintoatareddishappropriateadditives.Thespecificationalsoappliestoclosuresandrepeattheoperation.Evaporatethecombinedextractstoforcontainersforpowdersandfreez

5、e-driedproductstobedrynessonawater-bath.Dryat100-105°Cfor1h.Theresiduedissolvedinwaterimmediatelybeforeuse.Thespecificationweighsnotmorethan0.25mgpersquarecentimetreofinternaldoesnotapplytoclosuresmadefromsiliconeelastomer(whichsurfacearea.aredealtwithin3.1.9.Siliconeelastomerfo

6、rclosuresandExaminetheresiduebyinfraredabsorptionspectrophotometrytubing),tolaminatedclosuresortolacqueredclosures.The(2.2.24).Itshowsabsorptionbandstypicalofsiliconeoilatelastomersareproducedfromnaturalorsyntheticsubstances805cm−1,1020cm−1,1095cm−1,1260cm−1and2960cm−1.bypolymer

7、isation,polyadditionorpolycondensation.TheReducingsubstances.To20.0mLofsolutionSadd2mLnatureoftheprincipalcomponentsandofthevariousadditivesofsulfuricacidRand20.0mLof0.002Mpotassium(forexamplevulcanisers,accelerators,stabilisers,pigments)permanganate.Boilfor3min.Coolimmediately.

8、Add1gdependsonthepropertiesrequiredforthefinish