Biomaterial Database

Evaluation of robot automated chromogenic substrate LAL endotoxin assay method for pharmaceutical products testing. 1985

K Tsuji, and P A Martin

The robot automated chromogenic substrate LAL assay method was evaluated for endotoxin testing using three lots each of 12 pharmaceutical products. As many as 216 assays, including automated standard curve construction and sample preparation, can be performed in a single day of unattended operation. The method is linear (r greater than .99) in the range of 0 to 0.2 EU/ml. The precision of the method determined by assaying a lot of calcium gluconate for four days was 6%, 10%, and 10% for within an assay block, between assay blocks, and between assay days, respectively. Recovery of endotoxin when spiked into products ranged from 81% to 110% and was within the statistical variation (2 sigma limit) of the method. The endotoxin levels detected in a biological raw material by the chromogenic substrate assay method correlated well with that of the gel-clot LAL assay method. The endotoxin content of the majority of the pharmaceutical products tested was well below the sensitivity of both the chromogenic substrate and the gel clot LAL assay methods.

UI	MeSH Term	Description	Entries
D008033	Limulus Test	Sensitive method for detection of bacterial endotoxins and endotoxin-like substances that depends on the in vitro gelation of Limulus amebocyte lysate (LAL), prepared from the circulating blood (amebocytes) of the horseshoe crab, by the endotoxin or related compound. Used for detection of endotoxin in body fluids and parenteral pharmaceuticals.	Limulus Tests,Test, Limulus,Tests, Limulus
D011549	Pseudomonas	A genus of gram-negative, aerobic, rod-shaped bacteria widely distributed in nature. Some species are pathogenic for humans, animals, and plants.	Chryseomonas,Pseudomona,Flavimonas
D012015	Reference Standards	A basis of value established for the measure of quantity, weight, extent or quality, e.g. weight standards, standard solutions, methods, techniques, and procedures used in diagnosis and therapy.	Standard Preparations,Standards, Reference,Preparations, Standard,Standardization,Standards,Preparation, Standard,Reference Standard,Standard Preparation,Standard, Reference
D002863	Chromogenic Compounds	Colorless, endogenous or exogenous pigment precursors that may be transformed by biological mechanisms into colored compounds; used in biochemical assays and in diagnosis as indicators, especially in the form of enzyme substrates. Synonym: chromogens (not to be confused with pigment-synthesizing bacteria also called chromogens).	Chromogenic Compound,Chromogenic Substrate,Chromogenic Substrates,Compound, Chromogenic,Compounds, Chromogenic,Substrate, Chromogenic,Substrates, Chromogenic
D004340	Drug Contamination	The presence of organisms, or any foreign material that makes a drug preparation impure.	Drug Adulteration,Drug Contamination, Chemical,Drug Contamination, Microbial,Drug Contamination, Physical,Drug Impurity,Adulteration, Drug,Chemical Drug Contamination,Chemical Drug Contaminations,Contamination, Chemical Drug,Contamination, Drug,Contamination, Microbial Drug,Contamination, Physical Drug,Contaminations, Chemical Drug,Contaminations, Microbial Drug,Contaminations, Physical Drug,Drug Adulterations,Drug Contaminations,Drug Contaminations, Chemical,Drug Contaminations, Microbial,Drug Contaminations, Physical,Drug Impurities,Impurity, Drug,Microbial Drug Contamination,Microbial Drug Contaminations,Physical Drug Contamination,Physical Drug Contaminations
D004731	Endotoxins	Toxins closely associated with the living cytoplasm or cell wall of certain microorganisms, which do not readily diffuse into the culture medium, but are released upon lysis of the cells.	Endotoxin
D006801	Humans	Members of the species Homo sapiens.	Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D001331	Automation	Controlled operation of an apparatus, process, or system by mechanical or electronic devices that take the place of human organs of observation, effort, and decision. (From Webster's Collegiate Dictionary, 1993)	Automations