Endotoxin Detection by Gel-Clot Limit Test Method

Preparation of test solutions

Unless otherwise prescribed, prepare the solutions and dilutions with water BET. If necessary, adjust the pH of the solution under examination to 6.0 to 8.0 using sterile 0.lM hydrochloric acid BET, 0.lM sodium hydroxide BET or a suitable buffer prepared with water BET.

Prepare the sample solution at any dilution at or below MVD. Use water BET as a negative control (NC) and two positive controls. One of the positive controls consists of the CSE at a concentration of 2λ and the other consists of the test solution spiked with CSE to give a concentration of 2λ (PPC).

Method

Carry out the procedure on the test solutions in duplicate as described under Test for interfering factors.

Interpretation of results

The product under examination complies with the bacterial endotoxin test if the positive product control is positive and the negative control, as well as the test solutions, are negative. The test is not valid if the positive product control is negative or if the negative control is positive.

The product under examination meets the requirements of the test if the endotoxin content is less than the endotoxin limit stated in the individual monograph.
Related: Bacterial Endotoxin Test (BET or LAL Test) Validation

Retests

If a positive result is found for one of the test solution duplicates and a negative result for the other, the test may be repeated as described above. The results of the retest should be interpreted as for the initial test.

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