11 USP REFERENCE STANDARDS

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1、11USPREFERENCESTANDARDS美国药典对照品USPReferenceStandardsarehighlycharacterizedspecimensofdrugsubstances,excipients,reportableimpurities,degradationproducts,compendialreagents,andperformancecalibrators.TheyareexplicitlyrequiredinmanyPharmacopeialassaysandtestsandareprovidedsolelyforsuchuse.Asse

2、ssmentofthesuitabilityforuseinotherapplication(s)restswiththepurchaser.AUTHORITYFORESTABLISHMENTANDRELEASEUSPReferenceStandardsareestablishedandreleasedundertheauthorityoftheUSPCBoardofTrusteesuponrecommendationoftheUSPReferenceStandardsExpertCommittee,whichapproveseachlotasbeingsuitablef

3、oruseinitscompendialapplications.ForsomeReferenceStandardsapreliminaryreviewandapprovalissoughtfromotherExpertCommitteesoftheCouncilofExperts.ThedistributionofcontrolledsubstancesissubjecttotheregulationsandlicensingprovisionsoftheDrugEnforcementAdministrationoftheDepartmentofJustice.Indu

4、stryAdvisoryPanelsandotherexpertgroups(suchasProjectTeams)maybeassembledtoadviseUSPonvariousaspectsoftheReferenceStandardsProgram.HISTORYFutureavailabilityofthefirstUSPReferenceStandardswasannouncedin1926(USPX)“…inordertofacilitatetheadoptionofthebiologicalassaystandardsofthePharmacopoeia

5、,andtoprovideagreaterdegreeofuniformityintheirapplication.”ThelistofUSPReferenceStandardsthatin1936comprised6itemshasgrowntoalmost1650in2004,andthecollectionhastrackedtheprogressinpharmaceuticalsciences:Thefirstvitamins(CodLiverOil)andthefirstenzyme(Pepsin)in1936;thefirstsulfonamide(Sulfa

6、nilamide)andthefirsthormones(Insulin;PosteriorPituitary)in1942;thefirstperformancestandards(MeltingPointStandards)in1947;thefirstpenicillin(PenicillinGSodium)in1950;thefirstrecombinant-DNAtechnologyprotein(InsulinHuman)in1985,etc.ThecontinuousincreaseinthenumberofUSPReferenceStandards(ove

7、r100newstandardsarebeingdevelopedyearly)reflectsnotonlytheincreaseinthenumberofmonographsandGeneralChapters,butalsothedevelopmentandextensiveuseofmodernanalyticalmethodology(suchaschromatography,spectrophotometry,biologicalandbiochemicalassays,etc.)whichrequiremeasu