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Elimination
of pyrogens from drug products is of immense importance as its ill effects may
range from fever, rigors, hypotension, intravascular coagulation, shock and even
death.
LAL test
replaces now the outdated biological test on rabbits because its sensitivity is
almost twice than that of rabbit test. Besides, it is more accurate,
reliable, fast and less cumbersome.
LAL test thus
finds extensive scope of application in not merely the pharmaceutical world for
testing medicines, diagnostic substances, reagents, raw materials, finished
products or in-process quality control, but also for surgical instruments,
veterinary medicines, electronics, water purity systems, etc.
Experts and
authorities worldwide have accepted and appreciated the supremacy of this latest
technological breakthrough.
Proposed
forward as early as 1982 in the first draft, the U.S.FDA issued a definitive
document on it by 1987. Today, it is also incorporated in the United
States Pharmacopoeia and British Pharmacopoeia.
Mr. J.F.
Cooper, a clinical professor of pharmacy at the University of South Carolina,
USA, experimented with the Limulus Amoebocyte Lysate (LAL) Test some 20 years
ago to promote newer testing methods for the detection of pyrogens in
pharmaceutical products.
(Times of India, 11 Nov. 1993)
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