Pyrogens
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“Pyrogens” is a collective term of substances, which increase the temperature of the human body. However, many pyrogens, even in nano or microamounts result in other acute reactions like fever, diarrhea, hypotension, or intravascular agglutination (sludging of blood). In higher amounts, pyrogens lead to pyrogenic shock and lethal outcome. However, until now, only separate biological and chemical tests for pyrogens exist. Determination of p-aminophenol as a pyrogenic impurity in paracetamol dosage formulations A new procedure for determining p-aminophenol in paracetamol dosage formulations was developed (made it possible to decrease the determination time by a factor of 4). The limit of detection is 0.05 mg/mL , which provides a 20-fold increase in the sensitivity over conventional spectrophotometry. Determination of lipopolysaccharides The possibilities of determination of endotoxins by their polysaccharide part by thermal lensing are shown. The limits of detection of model polysaccharides are 2–5 mg/ml. The procedure was used for the determination of pyrogens in Pyrogenal dosage formulation. The limit of detection is 300 ng/ml (10S-criterion), which is an order below the concentrations used in the clinical practice. |
