Page 16 - Quality control of pharmaceuticals (07-PA 704) practical

VI. BACTERIAL ENDOTOXIN TEST METHODS

Definitions:

1 Bacterial Endotoxin Test:
This is a pharmacopeial test for the detection of Gram-negative endotoxins using the LAL
methodology.
2 Gel Clot Limit Test:
The gel clot limit test is a qualitative test for the detection of gram-negative bacterial endotoxin.The
assay is conducted by mixing LAL with test specimen followed by incubating the mixture
undisturbed for 60 minutes at 370C .If a gel has formed and remains intact after inversion of 1800,
test is positive, indicating that the endotoxin concentration of test specimen is greater or equal to
LAL’s labeled sensitivity. If intact gel has not formed test is negative.
3 PFW:
Pyrogen Free Water
4 CSE:
Control Standard Endotoxin
5 MVD:
Maximum Valid Dilution

Qualitative LAL test Procedure:
1. sample + LAL reagent (Gel)
2. Incubate at 37C for 60 min

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