DETECTION OF ENDOTOXIN IN PHARMACEUTICAL PREPARATIONS BY MASS SPECTROMETRY

摘要

The present invention relates to a method of detection of endotoxin in polypeptide compositions. In particular, this invention contemplates a method for measuring endotoxin by quantitating the amount of a volatile derivatized component of endotoxin, beta-hydroxymyristic acid, present in polypeptide compositions. The present invention can be used for testing the endotoxin content of products which are intended for use in clinical medicine, including those produced by recombinant DNA technology.