USP <85>

Bacterial Endotoxins Test

The objective is to detect or quantify endotoxins from Gram negative bacteria using amoebocyte lysate from the horseshoe crab.  There are three techniques for this test:  The gel-clot technique, which is based on gel formulation; the turbidimetric technique, based on the turbidity after cleavage of an endogenous substrate; and the chromogenic technique, based on the development of color after cleavage of a synthetic peptide –chromogen complex.  Microbac offers the turbidimetric technique.

Preparatory Testing

The USP requires that preparatory testing be performed for each product to verify the solution does not interfere with the test.  This is a one-time evaluation where the sample is spiked at least in duplicate with endotoxin and a recovery of 50 – 200% must be observed.

Turn Around Time

The turnaround time for regularly submitted samples 10 business days.  Expedited testing is available.  Turn-around time for Preparatory Testing can be completed in 10 business days but may be extended if the acceptance criteria are not met on the first pass. Expedited testing must be pre-arranged.

Sample Quantity

Unless otherwise directed in the monograph, 10 mL or 10g of material is to be tested.

Identification of Organisms

Microbac Laboratories stands ready to assist with identification of organisms using either spectroscopy in the form of MALDI-TOF or Biochemical analysis.

Matrix Assisted Laser Desorption/Ionization (MALDI) coupled with Time of Flight (TOF) is a powerful fast approach to identification of an organism.  The species is compared to a library generated by Bruker Corporation.

Biochemical analysis is performed using commercially available strips the results being compared to a database generated by Biomerieux.