Specific measurement of endotoxin can be performed using small amounts, avoiding any interference from coexisting substances, by adsorption of endotoxin from the sample on Pyrosep™ and its condensation.

• As endotoxin can be adsorbed on Pyrosep™ even in ethanol, endotoxin can be measured in a lipophilic sample by dissolving it in ethanol. These samples cannot normally be measured with a conventional limulus assay. (Examples: fat-soluble vitamins, oils and fats)

• No LAL reagent is wasted, as they are pre-packaged in individual vials and the required amount can be used per measurement.

Endotoxin from the sample is adsorbed onto a capillary column packed with Pyrosep™ (an affinity adsorbent, with histidine bound to a water-insoluble support via a spacer, specifically designed to adsorb endotoxin). The rest of the substances contained in the sample can be washed out; allowing the adsorbed endotoxin to activate the LAL reagent for its quantification, being able to carry out the measurement in a Toxinometer®.

Endotoxin detection in dialysis fluid
The samples were prepared using commercial dialysis fluid (dialysate X) and two types of substitution fluids for artificial kidneys (fluids Y and Z), with quantities of 5.0 mL in each case. USP Reference Standard Endotoxin was added to each and the pH was adjusted to ca. 5 with acetic acid. The endotoxin concentration in each sample was measured using the Pyrosep™ method and the added endotoxin was recovered. With the use of the Pyrosep™ method, endotoxin in dialysis fluid can be detected from a range of 0.1 EU/L.

Endotoxin Detection in Fat-Soluble Vitamins
To fat-soluble vitamins D, E and K dissolved in ethanol, USP Reference Standard Endotoxin was added. Endotoxin concentrations in the samples were measured using the Pyrosep™ method and spiked endotoxin was recovered from each sample. The use of the Pyrosep™ method allows the detection of endotoxins in fat-soluble vitamins, which cannot be measured with Limulus reagents.

Other examples
Ethanol, silicone oil, soybean oil, olive oil, stearic acid, egg yolk lecithin, vaccine adjuvant oil, albumins, coagulation factors (factor 8), interferon formulations, antithrombin III, immunoglobulin products and other samples soluble in ethanol.

Overcomes any product interference by absorbing possible endotoxins in your samples for PyrosepTM; washes inhibitory components and analyzes the endotoxins present in a non-inhibitory solution.

• Even fat-soluble samples can be analyzed as long as they can be dissolved in ethanol. Since endotoxin is adsorbed by Pyrosep™ in the presence of ethanol, fat-soluble vitamins, oils, and fats that are not typically suitable for traditional LAL assays can be analyzed using the Pyrosep™ method.

• No LAL reagent is wasted as LAL is supplied individually in single-assay vials and can be used in the exact amount required for measurement

Endotoxin detection in

• Hemodialysis and replacement fluid
• Fat-soluble vitamins
• Silicone oil
• Soy oil
• Stearic acid
• Egg yolk lecithin
• Vaccines with oil adjuvant
• Albumin