Biomaterial Database

Comparison of Limulus amebocyte lysates with the United States pharmacopeial pyrogen test and the portable test system for radiopharmaceuticals. 2010

Ralph Santos-Oliveira

Nuclear Engineering Institute, Radiopharmaceutical Division, Rua Hélio de Almeida No. 75, Ilha do Fundao, Rio de Janeiro, 21.941-906, Brazil. roliveira@ien.gov.br

Radiopharmaceuticals play an important role in modern nuclear medicine, and 18F-FDG (2-[18F] fluoro-2-deoxy-D-glucose) is the most frequently used in imaging examinations today. The pyrogen test represents an important parameter for the quality of radiopharmaceuticals since most of them, 18F-FDG included, are injectable solutions. However, the standard test proposed by the U.S. Pharmacopeia using limulus amebocyte lysates takes too long (about 1 h). An alternative test is the Portable Test System, which takes no more than 15 min. In order to compare both tests, 10 batches of 18F-FDG produced in the Nuclear Engineering Institute, Rio de Janeiro, Brazil, were analyzed. The results showed that in 40% of the samples analyzed, different results were found. From the total analyzed, 20% showed totally diverging results, and 80% demonstrated partial similarity. These differences have a great impact in the choice of the test used for radiopharmaceutical injectable solutions and the importance of validation tests before the implementation in the daily routine.

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
D010602	Pharmacopoeias as Topic	Works about authoritative treatises on drugs and preparations, their description, formulation, analytic composition, physical constants, main chemical properties used in identification, standards for strength, purity, and dosage, chemical tests for determining identity and purity, etc.	Formulary, National,National Formulary,Formularies, National,National Formularies
D011749	Pyrogens	Substances capable of increasing BODY TEMPERATURE and cause FEVER and may be used for FEVER THERAPY. They may be of microbial origin, often POLYSACCHARIDES, and may contaminate distilled water.	Pyrogen
D019275	Radiopharmaceuticals	Compounds that are used in medicine as sources of radiation for radiotherapy and for diagnostic purposes. They have numerous uses in research and industry. (Martindale, The Extra Pharmacopoeia, 30th ed, p1161)	Radiopharmaceutical
D019788	Fluorodeoxyglucose F18	The compound is given by intravenous injection to do POSITRON-EMISSION TOMOGRAPHY for the assessment of cerebral and myocardial glucose metabolism in various physiological or pathological states including stroke and myocardial ischemia. It is also employed for the detection of malignant tumors including those of the brain, liver, and thyroid gland. (From Martindale, The Extra Pharmacopoeia, 30th ed, p1162)	18F Fluorodeoxyglucose,18FDG,2-Fluoro-2-deoxy-D-glucose,2-Fluoro-2-deoxyglucose,Fludeoxyglucose F 18,18F-FDG,Fluorine-18-fluorodeoxyglucose,Fluorodeoxyglucose F 18,2 Fluoro 2 deoxy D glucose,2 Fluoro 2 deoxyglucose,F 18, Fludeoxyglucose,F 18, Fluorodeoxyglucose,F18, Fluorodeoxyglucose,Fluorine 18 fluorodeoxyglucose,Fluorodeoxyglucose, 18F