Validation of LAL test on some antibiotics: A study on the causes of different inhibitory effects

Abstract

Validation process is a program for ensuring products with proven acceptable and predetermined specification. The LAL test used for detection of endotoxin in the sterile parenteral products is one of the tests that require validation. During this study, validation of 12 parenteral antibiotics including penicillin and cephalosporin have been done using gel clot method and obtained results which prescribed relationship between molecular structure and inhibitory dilution. The inhibitory dilution for potassium penicillin G was 5 millions units, potassium penicillin G was 1 millions units and natrium penicillin G was 1:40. Ampicillin, penicillin G 6:3:3, 400,000 and 800,000 unit penicillin had inhibitory dilutions up to 1:20 . Cloxacillin inhibitory dilution was 1:80. and Cefotaxim, Cefepime, Ceftizoxime dilution results were 1:40, Cefuroxim, Ceftazidime were 1:20 and this result for Cefazolin was 1:80.The results were studied and presented their according to pharmaceutical group separately. None of evaluated antibiotics showed enhancement effect but inhibitory was observed which made a significant conclusion on the role of dilutions on this phenomenon