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Abstract

Comparative Evaluation Of Chromogenic Limulus Assay And Rabbit Pyrogen Test For Water For Injection

Author(s): Pradeep Nagalkar, Pushpa Kulkrani, C Viswanathan

A comparative study of application of CLAL (Chromogenic Limulus Amebocyte Lysate) and rabbit pyrogen test on 35 samples of Water for injection was performed. With the pyrogen test, the accumulated temperature rise ranged from + 0.2o to + 1.3o passing all the samples by the rabbit pyrogen test. The endotoxin content varied from as low as 0 EU/ml (Endotoxin Unit per milliliter) to 0.15 EU/ml as tested by CLAL test suggesting that all samples had endotoxin levels below the prescribed levels of 0.25 EU/ml. No correlation could be established between the endotoxin content and temperature rise.