Endotoxin testing

Handbook of Microbiological Quality Control in Pharmaceuticals and Medical Devices

Volumn , Issue , 2003, Pages 144-167

  Baines, Alan ^a  

^a BioWhittaker UK Ltd   (United Kingdom)

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EID: 1042276230     PISSN: None     EISSN: None     Source Type: Book    
DOI: None     Document Type: Chapter

References (22)

1. Bang, F. (1956) A bacterial disease of Limulus polyphemus. Bulletin of the Johns Hopkins Hospital, 98, 325-37.
2. British Pharmacopoeia (1999) The Stationery Office, London.
3. Cooper, J.F., Levin, J. and Wagner, H.N. (1970) New rapid in vitro test for pyrogen in short-lived radiopharmaceuticals. Journal of Nuclear Medicine, 11, 310.
4. Dabbah, R., Ferry, E., Jr, Gunther, D.A., Hahn, R., Mazur, P., Nelly, M., Nicolas, P., Pierce, J.S., Slade, T., Watson, S., Weary, M. and Sandford, R.L. (1980) Pyrogenicity of E. coli 055:B5 endotoxin by the USP rabbit pyrogen test - a HIMA collaborative study. Journal of the Parenteral Drug Association, 34, 212-16.
5. European Pharmacopoeia (1997) 3rd edn. Strasbourg, Council of Europe, pp. 286-7.
6. Guilfoyle, D.E. and Munson, T.E. (1982) Procedures for improving detection of endotoxin in products found incompatible for direct analysis with Limulus amoebocyte lysate. In: Watson, S.W., Levin, J. and Novitsky, T.J. (eds), Endotoxins and Their Detection With the Limulus Lysate Test. Alan R. Liss, New York, pp. 79-88.
7. Hort, E. and Penfold, W.J. (1912a) Microorganisms and their relation to fever. Journal of Hygiene, 12, 361-90.
8. H ort, E. and Penfold, W.J. (1912b) A critical study of experimental fever. Proceedings of the Royal Society. London [Biology], 85, 174-86.
9. Hort, E. and Penfold, W.J. (1912c) The relation of salvarsan fever to other forms of injection fever. Proceedings of the Royal Society of Medicine (Pt. 3), 5, 131-9.
10. Japanese Pharmacopoeia (1996) 13th edn. Tokyo, The Society of Japanese Pharmacopoeia.
11. Levin, J. and Bang, F.B. (1964) The role of endotoxin in the extracellular coagulation of Limulus blood. Bulletin of the Johns Hopkins Hospital, 115, 265-74.
12. Levin, J. and Bang, F.B., (1968) Clottable protein in Limulus-, its localisation and kinetics of its coagulation by endotoxin. Thrombosis, Diathesis and Haemorrhage, 19, 186-97.
13. Parenteral Drug Association (1980) A response to Federal Register 45, January 18, 1980. Interindustry communication.
14. Solum, N.O. (1970) Some characteristics of the clottable protein of Limulus polyphemus blood cells. Thrombosis, Diathesis and Haemorrhage, 23, 170.
15. Solum, N.O. (1973) The coagulation of Limulus polyphemus hemocytes. A comparison of the clotted and non-clotted forms of the molecule. Thrombosis Research, 2, 55.
16. Teller, J.D. and Kelly, K.M. (1979) A turbidimetric Limulus amebocyte assay for the quantitative determination of Gram-negative endotoxin. In: Cohen, E. (ed.), Biomedical Applications of the Horseshoe Crab (Limulidae). Alan R. Liss, New York, pp. 423-33.
17. United States Food and Drug Administration (1973) Limulus amoebocyte lysate: additional standards. Federal Register, 38, 26130.
18. United States Food and Drug Administration (1977) Licensing of Limulus amoebocyte lysate: use as an alternative for the rabbit pyrogen test. Federal Register, 42, 57789.
19. United States Food and Drug Administration (1987) A guideline on validation of the Limulus amoebocyte lysate test as an end-product endotoxin test for human and animal parenteral drugs, biological products and medical devices. Food and Drug Administration, Rockville, MD.
20. United States Pharmacopoeia (1995) 23rd edn. (85) Bacterial Endotoxins Test. US Pharmacopoeial Convention, Rockville, pp. 1696-7.
21. Weary, M.E. (1996) Pyrogens and pyrogen testing. In: Swarbrick, J. and Boylan, J.C. (eds), Encyclopedia of Pharmaceutical Technology, Vol. 13. Marcel Dekker, New York, pp. 179-205.
22. Young, N.S., Levin, J. and Prendergast, R.A. (1972) An invertebrate coagulation system activated by endotoxin: evidence for enzymatic mechanism. Journal of Clinical Investigation, 51, 1790.