Biomaterial Database

Variability in the LAL test: comparison of three kinetic methods for the testing of pharmaceutical products. 1992

K Z McCullough, and C Weidner-Loeven

MMI Associates, Whitehouse Station, New Jersey 08889.

Data presented in this study indicate that there is considerable variability in spike recoveries between three different kinetic LAL methods as used for the testing of a variety of parenteral products. However, successful spike recoveries were observed for each of the thirteen products under test on at least one of the three kinetic methods used, suggesting that problems caused by spike recovery variability may be easily controlled in the laboratory by flexibility in the choice of method.

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
D004364	Pharmaceutical Preparations	Drugs intended for human or veterinary use, presented in their finished dosage form. Included here are materials used in the preparation and/or formulation of the finished dosage form.	Drug,Drugs,Pharmaceutical,Pharmaceutical Preparation,Pharmaceutical Product,Pharmaceutic Preparations,Pharmaceutical Products,Pharmaceuticals,Preparations, Pharmaceutical,Preparation, Pharmaceutical,Preparations, Pharmaceutic,Product, Pharmaceutical,Products, Pharmaceutical