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Corporate HeadquartersAssociates of Cape Cod, Inc.124 Bernard E. Saint Jean DriveEast Falmouth, MA 02536-4445T (508) 540–3444 • F (508) 540–8680Online: www.acciusa.comUK Off i ceAssociates of Cape Cod Int’l Inc.Deacon Park, Moorgate RoadKnowsley, Liverpool L33 7RX, United KingdomT (44) 151-547-7444 • F (44) 151-547-7400 Online: www.acciuk.co.ukGerman Off i ceAssociates of Cape Cod PYROQUANT DIAGNOSTIK GmbHOpelstrasse 14, 64546 Mörfelden-Walldorf, GermanyT (49) 61 05-96 10 0 • F (49) 61 05-96 10 15 Online: www.pyroquant.de9PN001443-9 Rev6LAL ReagentsControl Standard Endotoxin (CSE)General Product Description Control Standard Endotoxin (CSE) is a widely used standard for endotoxin testing. It is a purif i ed extract from E. coli O113:H10, the same strain used for the United States Pharmacopeia and the European Pharmacopeia Reference Standard Endotoxin (RSE).CSE is an economic alternative to the RSE. CSEs are standardized against the RSE as indicated on the Certif i cate of Analysis, so that results can be reported in Endotoxin Units (EU) and International Units (IU). CSE can be used for all routine LAL testing. A 10 ng/vial CSE is made specif i cally for use with our Pyrochrome ® chromogenic reagent.Depyrogenation Controls In addition to their use as standards for controlling LAL tests, the 0.5 µg and 125 µg CSEs can be used for validation of depyrogenation processes. They may be used directly, without reconstitution, as depyrogenation indicators (recommended for 0.5 µg) or can be reconstituted and endotoxin added to challenge articles (recommended for 125 µg).Performing the Test CSE is used to make standard curves and controls when performing the LAL assay. The concentrations used are dependent on the type of assay and for photometric methods (chromogenic and turbidimetric), the detection range required.Reconstitution CSE is reconstituted with LAL Reagent Water (LRW). Please refer to the Certif i cate of Analysis when using CSE. A Certif i cate of Analysis for each CSE-LAL lot combination can be obtained from ACC or online at www.acciusa.com.Stability Once reconstituted, CSE stored at 2–8°C is stable for maximum storage time for the different CSE preparations as listed below: 10 ng/vial - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -7 days 0.5 µg/vial - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4 weeks 125 µg/vial- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3 months CSE should not be frozen.Product Benef i ts • CSE is a premium, stable, preparation of endotoxin that can be used in all LAL testing• CSE E0005 and E0125 can be used for depyrogenation studies• Certif i cates of Analysis for each CSE-LAL lot pairing gives a potency that is specif i c to the unique lot combination• CSE can be reconstituted to achieve specif i c endotoxin concentrationsPackaging The 10 ng/vial CSE is available in packs of fi ve vials. Both the 0.5 and 125 µg/vial CSE are sold individually.Control Standard Endotoxin, Escherichia coli O113:H10#E0005-1- - - - - - - - - - - - - - - - - - - - - - - - - - 0.5 µg/vial (1 pack) #E0005-5- - - - - - - - - - - - - - - - - - - - - - - - - - 0.5 µg/vial (5 pack) #E0005-25 - - - - - - - - - - - - - - - - - - - - - - - - -0.5 µg/vial (25 pack)#E0125-1- - - - - - - - - - - - - - - - - - - - - - - - - - 125 µg/vial (1 pack) #E0125-5- - - - - - - - - - - - - - - - - - - - - - - - - - 125 µg/vial (5 pack)#EC010-5- - - - - - - - - - - - - - - - - - - - - - - - - - - 10 ng/vial (5 pack) For more information please visit our website at www.acciusa.com or contact Customer Service at (508) 540-3444.