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EU/ vlal 100, Thevialcontains OO'000 solution) EU/ ml)(Stock = EU 00'000 / vial+ 5 20' 00'000 LRW(100, Add5ml * Vortex for 15 minutes' "8" "A' tubes12x 75mm'label and Takedilution EU 2,oo,ooo / ml + "A' Add0'1 ml (stock) 0'9 ml LRw = 1 : rb (n), ln tube EU -- 1 : 100(B),2O,OO0 i ml 0'1ml(A)+ 0'9 ml LRW to be tested or * Determine numberof Ampoules vials the A d d o , l m l f r o m t u b e ( B ) t o e a c h o f t h e a m p o u | e s inroven) . o Vi.l|s keeping before vials (Mark Airdryandsealtheampoules' and use the rest r v r aside as positivecontrols Keep two uittt (unbtktO) Depyrogenation' cycleas peryour requirement * Allowthe vialsto go throughthe depyrogenation temperature the Allow vialsto coolto room (lMP) vialsandvortexfor 10 minutes LRWto eachof baked Add1 ml vialadd0'1 ml of lysate' Take0.1mlfromeachof baked 0' (Sensitivity12SEU/ml) minutes vial' unbaked vortexfor 10 add control' 1mlLRWto the positive Fortesting

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06EUirpl (d) 0. 1m l( l ) + 2 .logendotoxin concentrationthebaked of vials.5ml LRW + 0. 4m lL R W 1 :1 0 . to assay 1/10 of a dilution the baked Reconstituted vials.1ml(e)+ 0.vantx I ) ) .000 1250 Eu/vial x x forbaked vials =0.5ml LRW = = = = = 0.903) 4 Note:To limit logreduction the calculation 3 logs. 0.i.5ml LRW + 0.1ml Lysate 0.5EU/ml (a) 0.1ml Lysate 0. Forpositive controltakefrom tube(lll).5ml LRW + 0. 9 lL R W 1 : 4 0 0 m 0 .1ml (b)+ 0.1m| Lysate 0.5ml (b) 0. '1250 Minimum reduction = log log EU/vial log0. 0 0 E u / m l + 1 .125Eulvial * Calculatethe minimum log reductionas follows: log Minimum reduction = logEndotoxin concentrationtheunbaked of control Vials. * Dilution 0 . t t I I ) 4fi. 1 m(1l ) (l) (ll) (lll) I I t ) ) ) ) .097 (-0.1ml (d)+ 0. 1m lo f 2 0 .125Eu/vial = = 3.5ml(d) + 3 ml LRW + 0.000 a fromthe unbaked vialsas shownbelow. .e.125 EUiml(c) 0..5ml (a) 0.03EU/rnl (e) I I ) I I I * Perform test in duplicatein a assaytube. 9L R W 0 1:20 + 1 .125 Eu/ml 1ml/vial 1 x x =0. * Prepare dilutionof 1: 10.1ml (c)+ 0.1ml Lysate * Form ula i = Lysate Endotoxin Concentration sensitivityreconstituted x volume dilution x = 0. 0 0 0 l 0 .25EU/ml (b) 0.1of (lll)+ 0.1oflysate. prepare Forcarrying Standard out Curve dilution tube(lll)2 EUlml follow from as 1 ml (2 EU/ml) 0.5ml(c) 0. the 0.125 = Forunbaked vials Eu/ml 1 ml/vial 10.

Lot EndotoxlnChallenge No: Date: HeatingBlock TemP: End: of Expiry CSE: of Expiry CSEReconstitution Potency: Time Start: Expiry Time Oven/ TunnelMake : : Temperature AS NOT COMPLIES PERUSP/ BP/ I P .TESTCOMPLIES DOES TestdonebY & Name Signwith Seal bY Reviewed Name& Signwith Seal bY Approved ame& SignrvithSeal . Lysate :Nameof the CompanY Date :Validationof :of Details the Reagents. / : Resulis . LAL LotNo: No: Lot CSE No: LRW Lot of Expiry LAL: LRW: On: LAL Reconstitution On.Amebocye use Gel the employs Semi-Qualitative testwhichmakes of Limulus Thetestmethod of (LAL) whichclotsin thepresence endotoxin.

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