Endotoxin Detection by Kinetic Thrbidimetric and Kinetic Chromogenic Methods : Pharmaceutical Guidelines

Endotoxin Detection by Kinetic Thrbidimetric and Kinetic Chromogenic Methods

Learn how to detect Endotoxin by Kinetic Thrbidimetric and Kinetic Chromogenic Methods.

Preparation of test solutions

Unless otherwise prescribed, prepare the solutions to be employed in the test using water BET. If necessary, adjust the pH of the solution under examination to 6.0 to 8.0 using sterile 0.1 M hydrochloric acid BET, 0.1 M sodium hydroxide BET or a suitable buffer prepared with water BET.

Prepare the test solution at a suitable dilution

Use not less than three CSE concentrations to prepare a linear standard curve. Use water BET as a negative control and one positive control. The positive control consists of the test solution spiked with CSE to give an endotoxin concentration at the middle or below the middle point of the standard curve (PPC).
Related: Bacterial Endotoxin Test (BET or LAL Test) Validation


Carry out the procedure described under Test for interfering factors.

Interpretation of results

The assay is valid only if
(a) the standard curve is linear for the range of CSE concentrations used;
(b) the coefficient of correlation, r, is not greater than -0.980;
(c) the mean percentage recovery of the added endotoxin in the positive product control is between 50 percent and 150 percent.

The product under examination meets the requirements of the test if the mean endotoxin content of the replicates, after correction for dilution and concentration, is less than the endotoxin limit stated in the individual monograph.
Also see: Hold Time Study of Prepared Control Standard Endotoxin (CSE)

Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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