Biomaterial Database

Detection of endotoxin in biological products by the limulus test. 1977

J F Cooper, and S M Pearson

The limulus amebocyte lysate (LAL) test is established as a beneficial quality assurance measure for the parenteral drug industry because of its sensitivity, specificity, and simplicity. Limulus amebocyte lysate reacts with various forms of endotoxin to form an opaque gel under acceptable conditions of pH, temperature, and ionic content. Although certain materials and conditions may alter the lysate-endotoxin reaction, the test is not significantly limited by inhibition or non-specific activation. Many U.S. drug firms apply the LAL test generally for monitoring production water and other ingredients, for an in-process control, and as a supplemental end product test for pyrogenic contamination. Specific applications are made for bacterial and viral vaccines, antineoplastic agents, radiopharmaceuticals and drugs designed for intrathecal injection. Efforts to standardize LAL test technique and lysate potency continue.

UI	MeSH Term	Description	Entries
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
D006737	Horseshoe Crabs	An arthropod subclass (Xiphosura) comprising the North American (Limulus) and Asiatic (Tachypleus) genera of horseshoe crabs.	Crabs, Horseshoe,Limulus,Limulus polyphemus,Tachypleus,Xiphosura,Crab, Horseshoe,Horseshoe Crab,Xiphosuras
D000818	Animals	Unicellular or multicellular, heterotrophic organisms, that have sensation and the power of voluntary movement. Under the older five kingdom paradigm, Animalia was one of the kingdoms. Under the modern three domain model, Animalia represents one of the many groups in the domain EUKARYOTA.	Animal,Metazoa,Animalia
D001181	Arthropods	Members of the phylum Arthropoda, composed of organisms having a hard, jointed exoskeleton and paired jointed legs. It includes the class INSECTS and the subclass ARACHNIDA, many species of which are important medically as parasites or as vectors of organisms capable of causing disease in man.	Arthropoda,Arthropod
D001681	Biological Assay	A method of measuring the effects of a biologically active substance using an intermediate in vivo or in vitro tissue or cell model under controlled conditions. It includes virulence studies in animal fetuses in utero, mouse convulsion bioassay of insulin, quantitation of tumor-initiator systems in mouse skin, calculation of potentiating effects of a hormonal factor in an isolated strip of contracting stomach muscle, etc.	Bioassay,Assay, Biological,Assays, Biological,Biologic Assay,Biologic Assays,Assay, Biologic,Assays, Biologic,Bioassays,Biological Assays