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LAL-Endotoxin Regulations

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ICH LAL-Endotoxin Guideline
This chapter provides a test for bacterial endotoxins that may be present in or on a sample. It has been streamlined and presents two gel-clot procedures (in the Gel-Clot Limit Test and in the Gel-Clot Assay) and two photometric procedures (a turbidimetric technique and a chromogenic technique). The Gel-Clot Assay procedure is new for this chapter and is used to quantitate the level of endotoxins in a sample.

 2001-01-01   PDF PDF file (242 KB) 

Limulus Amebocyte Lysate; Reduction of Samples for Testing
21 CFR Part 660. The FDA is amending its biologics regulations to include additional standards for LAL; by reducing the number of containers submitted for potency and quality tests, and the number of samples required to be submitted to FDA for testing, FDA Final Rule

 1997-01-01   PDF PDF file (294 KB) 

Guideline on Validation of the Limulus Amebocyte Lysate Test as an End-Product Endotoxin Test for Human and Animal Parenteral Drugs, Biological Products, and Medical Devices
This guideline sets out acceptable conditions for use of the LAL test. It also describes procedures for using this methodology as an end-product endotoxin test for human and animal injectable drugs, and medical devices, FDA

 1997-01-01   PDF PDF file (4 MB) 

Interim Guidance for Human and Veterinary Drug Products and Biologicals
Kinetic LAL Techniques - Until updating of the guideline is completed, the following recommendations with the lysate manufacturers approved procedures can be used. Kinetic LAL techniques should be performed in accordance with the lysate manufacturers recommended procedures, i.e., sample/lysate ratio, incubation temperature and times, measurement wavelength, etc., FDA

 1991-01-01   PDF PDF file (16 KB) 

Maximum Valid Dilution
This document helps to determine how much a product can be diluted and still be able to detect the limits of endotoxin concentration.

    PDF PDF file (26 KB) 

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