Test Services

Endotoxin

BACKGROUND
Endotoxin: Endotoxins are lipopolysaccarides (LPS) or lipooligosaccharides (LOS), found in the outer membrane of various Gram-negative bacteria. When injected into the body, they may cause anything from mild to severe inflammation, to in the most severe cases, septic shock.

Presence of endotoxins in a compound is evidence of a current or previous contamination. Removal of endotoxins requires a specialized filtration system, and they are not removed by 0.2um filters used to sterilize compounded medications. Some typical sources of endotoxins are raw materials, water, instruments and reagents that are stored and used to compound, for example solutions used to adjust the pH of solution.

OUR METHODOLOGY
DYNALABS employs the kinetic chromogenic and photometric quantitative testing methodologies, the kinetic-chromogenic, and the kinetic-turbidimetric methodologies. Both technologies are sensitive down to 0.005 EU/mL. The test protocols are based on guidelines delineated in USP <85> Bacterial Endotoxins Test.

Samples are assayed in quadruplicate against a five standard curve run in duplicate. Two of the quadruplicate samples are spiked with a known amount of endotoxin that must recover within an acceptable range to verify that the sample is not inhibiting the test.

FORMS TESTED

• Oil Injections
  
• Aqueous Injections
  
• Suspensions
  
• Sterile Solutions
  
• Pellets
  
• Powders