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Acila

Reference Standard Endotoxin (RSE)

Endotoxins (LPS)

ACILA® offers Reference Standard Endotoxins of USP and EP.

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ACILA® offers endotoxins (lipopolysaccharides or LPSs) for various applications, including Limulus Amebocyte Lysate Tests (LAL Test) and Pyrogen Tests. They can also be used as bioindicators for the validation of depyrogenation processes or ultrafiltration. The endotoxins are from different species of bacteria and therefore contain different amounts of lipid A, which means that their activity also varies. Our endotoxins are highly purified and do not contain any fillers, opposite to most endotoxin preparations.

The Pharmacopoeias (Europe, USA, Japan), the World Health Organisation (WHO) and the Food and Drug Administration (FDA) differentiate between Reference Standard Endotoxin (RSE) and Control Standard Endotoxin (CSE). Due to the harmonization of Limulus Amebocyte Lysate Test (LAL Test) in the three pharmacopoeias, there are only activity-identical endotoxin units since 1997:

1 I.U. (I.E) (International Unit) = 1 E.U. (Endotoxin Unit, FDA) = 1 USP Unit

These Reference Standard Endotoxins are, however, still found with different product names and with different units depending on their origin. The International Standard of the WHO and the EC-6 of the FDA are available only for certain reference laboratories or producers of Limulus lysate, while the Reference Standard Endotoxins of USP and EP can be purchased from ACILA.

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