Description:

RossixTris10%BSA(BovineSerumAlbumin)StockSolution,100mlisadiluentbufferforsensitiveproteinssuchascoagulationfactors.

Composition:

StockSolution, 0.5mol/LTris.HClpH7.3(at20°C),2mol/LNaCl,10%BSA

Validation:

AllnewbatchesofBovineSerumAlbumin (BSA)arecarefullyvalidatedpriortoapprovalfor use in Rossix buffers and reagents. ApprovalofanewbatchofBSAconsistsofthefollowing:

Testasbulkingagent–FVIII method

TheBSAistestedasabulkingagentinaFVIIImethod.ThestABIlityandperformanceofsampleandreagentsolutionsisevaluated.

Testasbulkingagent–FVIImethod

TheBSAistestedasabulkingagentinaFVIImethod.Thestabilityandperformanceofsampleandreagentsolutionsisevaluated.

Absenceofproteasactivity

Thenewbatchistestedforabsenceofproteasactivitybyincubationwithachromogenicsubstratewithabroadselectivity.

Controloforigin

RossixrequestsdocumentswhichdemonstratesthesourceofbovineplasmausedformanufacturingofBSAtooriginatefromcountriesshowntobefreefromTSEsaffectinganimals,includingBSEandscrapie.