Description

RecombinantHirudinisderivedfromyeastandthepolypeptidechaincontains65 aminoacidsanditsMwis6979.5 daltonwhichisidenticaltonaturalHirudinexceptforthesubstitutionofleucineforisoleucineattheN-terminalendofthemoleculeandtheabsenceofasulfategrouponthetyrosineatposition63. TheRecombinantHirudinispurifiedbyproprietarychromatographictechniques.

Source

PichiaPastoris

Purity

Greaterthan95.0%asdeterminedby:(a)AnalysisbyRP-HPLC.(b)AnalysisbySDS-PAGE.

BIOLOGicalActivity

Thebiologicalactivityismeasuredusingchromogenicassay,1 unitisdefinedastheamountofHirudinthatneutralizes1 unitoftheWHOpreparation89/588ofthrombin.Thespecificactivitywasfoundtobe16,000 ATU/mgprotein.

Formulation

Eachmgofproteinwaslyophilizedfromasterilesolutioncontainingno20 mMPBSpH-7 and2%mannitol.

Shipping

Atambienttemperature.Uponreceipt,storetheproductatthetemperaturerecommended below.

Storage/Expiration

LyophilizedHirudinalthoughstableatroomtemperaturefor3 weeks,shouldbestoreddesiccatedbelow –18°C.UponreconstitutionHirudinshouldbestoredat4°Cbetween2–7daysandforfutureusebelow –18°C.Forlongtermstorageitisrecommendedtoaddacarrierprotein(0.1%HSAorBSA).Pleasepreventfreeze-thawcycles.

PhysicalAppearance

Sterilefilteredwhitelyophilized(freeze-dried)powder.