Control Standard Endotoxin

A Standard for Endotoxin Testing

Control Standard Endotoxin (CSE) is a widely used secondary standard for endotoxin testing. It is a purified extract of Escherichia coli O113:H10, the same strain as United States Pharmacopeia Reference Standard Endotoxin (RSE).

CSE is an economic alternative to the RSE and its use instead of RSE is fully supported by regulatory bodies. Each lot of CSE must be standardized against RSE with each lot of reagent for BET as indicated on the Certificate of Analysis. The results are then reported in Endotoxin Units (EU) or International Units (IU). CSE can be used for all BET assays.

Product Details

Key Features of Control Standard Endotoxin for LAL Testing

CSE is a stable preparation of endotoxin that can be used in all BET assays
Certificates of Analysis for each CSE-lysate lot pairing give a potency that is specific to the unique lot combination
Per Certificates of Analysis, CSE is reconstituted with recommended volume of LRW to achieve specific endotoxin concentrations
Some CSEs are designated for depyrogenation studies

Test Performance

CSE is used to generate standard curves and assay controls. The dilution series depends on the assay type (e.g., chromogenic, gel-clot, or turbidimetric), instrumentation, and validated conditions. CSE is also used to prepare Positive Product Controls (PPCs) for each sample, as described in BET pharmacopeial chapters.

In addition, CSE may be used to prepare positive controls and to support Low Endotoxin Recovery (LER) studies and sample treatment studies.

Reconstitution

CSE is reconstituted with LAL reagent water only. Refer to the Certificate of Analysis (specific for each CSE-lysate lot combination) for recommended LRW volumes.

Product Configurations:

E0005 is 0.5 µg/vial CSE:
- Used with Pyrotell^®-T, Chromo-LAL and Pyrotell^®
- It can be also used for depyrogenation ovens qualifications.
EC010-5 is 10 ng/vial CSE:
- Used with Pyrochrome^® and PyroSmart NextGen^®
E0125 is 125 µg/vial CSE:
- Exclusively used for depyrogenation studies (does not come with a Certificate of Analysis)

Stability

Once reconstituted, stability is dependent on the type of CSE if stored at 2–8°C:

10 ng/vial: 7 days
0.5 µg/vial: 28 days
125 µg/vial: 3 months

Reconstitutes CSEs may not be frozen.

ORDERING INFORMATION

E0005 and E0125 are available as a pack of 1 or a pack of 5 vials.
EC010 is available as a pack of 5 vials.

Safety Data Sheets

Click on the links below to view Safety Data Sheets.

Product Literature

Click on the links below to view product literature.

Package Inserts
Accessory Products Brochure

Product Codes

Product Description	Product Code
Escherichia coli O113:H10, 0.5 µg/vial 1 Pack	#E0005-1
Escherichia coli O113:H10, 0.5 µg/vial 5 Pack	#E0005-5
Escherichia coli O113:H10, 125 µg/vial 1 Pack	#E0125-1
Escherichia coli O113:H10, 125 µg/vial 5 Pack	#E0125-5
Escherichia coli O113:H10, 10 ng/vial, 5 vials per pack, for use with Pyrochrome^® kits 5 Pack	#EC010-5

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