title: [False positive and false negative results in testing for pyrogenic impurities].
abstract: Causes of the occurrence of pyrogenic impurities in injection and infusion preparations as well as false-positive and false-negative results possible in the pyrogen test are reported. Possibilities of excluding pyrogenic impurities in the preparations concerned and of avoiding false-positive and false-negative results in the pyrogen test are discussed.
authors.affiliation: Institut für Arzneimittelwesen, Berlin.
authors.forename: H
authors.initials: H
authors.lastname: Dressel
mesh_terms: D000818:Animals; D002682:Chinchilla; D003013:Clostridium; D004096:Dihydrostreptomycin Sulfate / Q000032:analysis; D004340:Drug Contamination; D005188:False Negative Reactions; D005189:False Positive Reactions; D011398:Promethazine / Q000032:analysis; D011749:Pyrogens / Q000633:toxicity*; D011817:Rabbits; D012015:Reference Standards; D013171:Spores, Bacterial; D013328:Strophanthins / Q000032:analysis
chemical_list: D011749:Pyrogens; D013328:Strophanthins; D011398:Promethazine; D004096:Dihydrostreptomycin Sulfate
vernacular_title: Falschpositive und falschnegative Resultate bei der Prüfung auf pyrogene Verunreinigungen.