LAL Test vs Pyrogen Test


I have been looking for information about the limit of endotoxin for Diclofenac Potassium/Sodium and Etamsylate (Injectable); looking at the USP 35 (the respective monograph for those drugs); the limit is not specified. Actually, in the Pharma Industry that I work for, we use the pyrogens test for Diclofenac/etamsylate but I would like to validate the method using LAL Test. :confused:

Do you know if the LAL test can be applied to those products? If it is not possibly, Which is the main reason to do not validate the method with those drugs (Is there something interfering with the assay to avoid get limits)?. Would you like to send me some references (If you have it) to support my research?

Thanks in advanced for your answer. :smiley: