Control Standard Endotoxin (CSE) Control Standard Endotoxin (CSE) is a standard for endotoxin testing. It is a purified 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 Certificate of Analysis, so that results can be reported in Endotoxin Units (EU) and International Units (IU). CSE can be used for all routine BET testing. A 10 ng/vial CSE is made specifically for use with our Pyrochrome ® chromogenic reagent. Performing the Test CSE is used to make standard curves and controls when performing the BET assay. The concentrations used are dependent on the type of assay and for photometric methods (chromogenic and turbidimetric), the detec- tion range required. Reconstitution CSE is reconstituted with LAL Reagent Water (LRW). Please refer to the Certificate of Analysis when using CSE. A Certificate of Analysis for each CSE-LAL lot combination can be obtained from ACC or online at www.acciusa.com. Depyrogenation Controls In addition to their use as standards for controlling BET 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 depyrogena- tion indicators (recommended for 0.5 μg) or can be reconstituted and endotoxin added to challenge articles (recommended for 125 μg).
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 Benefits • CSE is a stable preparation of endotoxin that can be used in all BET testing • CSE E0005-1 and E0125-1 can be used for depyrogenation studies • Certificates of Analysis for each CSE-LAL lot pairing gives a potency that is specific to the unique lot combination • CSE can be reconstituted to achieve specific endotoxin concentrations Control Standard Endotoxin, Escherichia coli O113:H10
#E0005-1 0.5 μg/vial (1 pack) #E0005-5 0.5 μg/vial (5 pack) #E0125-1 125 μg/vial (1 pack) #E0125-5 125 μg/vial (5 pack) #EC010-5 10 ng/vial (5 pack)
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