METHOD OF ASSAY OF PHARMACEUTICAL PREPARATION PYROGENIC PROPERTY (PYROTEST) Russian patent published in 1997 - IPC

FIELD: analytical immunology. SUBSTANCE: assay is carried out in vitro by the presence of pyrogene in drugs. Pyrogene is sorbed in well plates (preferably - styrene) and detected by immunoenzyme reaction using serum raised to glycolipid of hemotype Re, native animal serum, protein A conjugated with enzyme and a mixture of substrate with chromogen. Reaction result is recorded by photometry, by staining intensity. The presence of pyrogene is determined if an average photometric index of the examined sample exceeds that of negative control. Method ensures to detect pyrogene at concentration at least 2 ng/ml. Method can be used for immune diagnosis of drugs used for parenteral administration and for estimation of production contamination with bacterial endotoxin in the process of pharmaceutical producing process. EFFECT: improved method of assay. 2 cl