Product Description

Control Standard Endotoxin (CSE) is a widely used standard for endotoxin testing. It is a purified extract of E. coli O113:H10, the same strain used for the United States Pharmacopeia and the European Pharmacopeia reference standard endotoxin (RSE).

CSE is used as 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 LAL testing. A 10 ng/vial CSE is made specifically for use with our Pyrochrome^® chromogenic reagent.

Test Performance

CSE is used to make standard curves and controls when performing the LAL assay. The concentrations used are dependent on the type of assay (e.g., chromogenic, gel-clot, or turbidimetric) and for photometric methods, the detection range required.

Product Stability

CSE is reconstituted with LRW or equivalent, and is stored at 2–8°C before and after reconstitution. Once reconstituted, the maximum storage time for the different CSE preparations is listed below.

10 ng/vial - - - - - - - - - - - - - - - - - - - - - - - - - -7 days
0.5 µg/vial - - - - - - - - - - - - - - - - - - - - - - - - 4 weeks
125 µg/vial - - - - - - - - - - - - - - - - - - - - - - - 3 months
CSE should not be frozen.

Product Reconstitution

CSE is reconstituted with LAL Reagent Water (LRW) (or equivalent). Please refer to the Certificate of Analysis when using CSE. A Certificate of Analysis exists for each CSE-lysate lot combination.

Product Packaging

The most commonly used size is 0.5 μg/vial. The 0.5 μg/vial is also used for testing depyrogenation ovens. The 125 μg/vial is typically used for special purposes, e.g., making endotoxin challenge articles for validation of depyrogenation processes. The 10 ng/vial CSE is available in packs of five vials.

Product Benefits

• CSE is a stable, preparation of endotoxin that can be used in all LAL testing
• CSE is especially useful for depyrogenation studies
• Certificates of Analysis for each CSE-lysate lot pairing gives a potency that is specific to the unique lot combination
• CSE can be reconstituted to achieve specific endotoxin concentrations