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Pandiyan, J.
- Sorting out of Interference in Detection of Endotoxins in Biotherapeutic Drugs
Abstract Views :382 |
PDF Views:172
Authors
Affiliations
1 P.G. Department of Zoology, Jamal Mohamed College (Autonomous), Tiruchirappalli, IN
2 P.G. Research Dept. of Zoology & Wildlife Biology, AVC College (Autonomous), Mannampandal-609 305, TN, IN
1 P.G. Department of Zoology, Jamal Mohamed College (Autonomous), Tiruchirappalli, IN
2 P.G. Research Dept. of Zoology & Wildlife Biology, AVC College (Autonomous), Mannampandal-609 305, TN, IN
Source
Indian Journal of Science and Technology, Vol 2, No 11 (2009), Pagination: 20-22Abstract
The effect of varying interference factors responsible for false positive results was investigated. The interfering factors inhibiting the endotoxins in activated lymphocytes sample was sorted by heat denaturation. These activated lymphocytes are biotherapeutic drugs which are used for autologous immune enhancement therapy. The technique used for denaturation can be applied to protein samples as well, to get rid of inhibition while quantifying endotoxins.Keywords
LAL, CSE, Bacterial Endotoxin, Endotoxin Limit and InterferenceFull Text
References
- Bang FB (1956) A bacterial disease of Limulus polyphemus. Bull. Johns Hopkins Hosp. 58, 325-351.
- Cooper JF (1990) Resolving LAL test interferences. J. Parenteral Sci.Tech. 44, 13-15.
- FDA LAL Test Guideline (2009) Bacterial endotoxin test. USP 32 (85).
- Mc Closky WT, Prince CW, Van Winkle WJ, Welch H and Calvery HO (1943) Results of first USP collaborative study of pyrogens. J. Am. Pharm. Assoc. 32, 69-73.
- Good CM and Lane Jr. HE (1977) The biochemistry of pyrogens. Bull. Parenter. Drug Assoc. 31, 116-120.
- Pearson FC (1991) Limulus amebocyte lysate testing: comparative methods and reagents. In: Sterile Pharmaceutical Manufacturing: Applications for the1990s. Eds. Groves MJ, Olson WP & Anisfe1d MH, Vo1.2. Interpharm Press. pp: 185-197.
- Sullivan JD and Watson SW (1975) Purification and properties of the clotting enzyme from Limulus lysate. Biochem. Biophys. Res. Commun. 66, 848-855.
- USP 24-NF (1999) Bacterial Endotoxins Test. 2nd Supplement, 85. The USP Convention, Rockville, MD. pp: 2875-2879.
- van Noordwijk J and DeJong Y (1977) Comparison of the LAL test with the rabbit test: false positives and false negatives. Dev. Boil. Stand. 34, 39-43.
- Determination of NID Factor in cephalosporin Antibiotics
Abstract Views :345 |
PDF Views:124
Authors
Affiliations
1 P.G. Department of Zoology, Jamal Mohamed College (Autonomous), Tiruchirappalli, IN
2 P.G. Research Dept. of Zoology & Wildlife Biology, AVC College (Autonomous), Mannampandal-609 305, TN, IN
1 P.G. Department of Zoology, Jamal Mohamed College (Autonomous), Tiruchirappalli, IN
2 P.G. Research Dept. of Zoology & Wildlife Biology, AVC College (Autonomous), Mannampandal-609 305, TN, IN
Source
Indian Journal of Science and Technology, Vol 2, No 12 (2009), Pagination: 40-43Abstract
Cephalosporin antibiotics are the most widelyused as life saving drugs. The drug is subjected to bacterial endotoxins test before releasing into market but due to interfering factors in most of the cases there is a probability of getting false positive results. Hence, noninterfering dilution (NID) to be selected before validating the product. Single product from 1st to 4th generation cephalosporins were selected in this study and the NID factor among those Cephalosporin antibiotics is found between ± two fold.Keywords
Cephalosporin Antibiotics, Endotoxin Test, Noninterfering Dilution (NID)Full Text
References
- Atherton R and Furr M (2009) Endotoxin release after antimicrobial treatment in sick foals is mediated by antimicrobial class. J. Equine Vet. Sci. 26 (8) 356-363.
- Bang FB (1956) A bacterial disease of Limulus polyphemus. Bull. Johns Hopkins Hosp. 58, 325-351.
- Cooper JF (1990) Resolving LAL test interferences. J. Parenteral Sci.Tech. 44, 13-15.
- Good CM and Lane Jr. HE (1977) The biochemistry of pyrogens. Bull. Parenter. Drug Assoc. 31, 116-120.
- Mc Closky WT, Prince CW, Van Winkle WJ, Welch H and Calvery HO (1943) Results of first USP collaborative study of pyrogens. J. Am. Pharm. Assoc. 32, 69-73.
- Michael J. Hausmann, Robert Yulzari, Eli Lewis, Yaniv Saisky and Amos Douvdevani (2000) Gel clot LAL assay in the initial management of peritoneal dialysis patients with peritonitis: a retrospective study. Nephrol. Dial. Transplant. 15, 680-683.
- Pearson FC (1991) Limulus amebocyte lysate testing: comparative methods and reagents. In:
- Sterile pharmaceutical manufacturing: applications for the1990s. Eds. Groves MJ, Olson WP & Anisfe1d MH, Vo1.2. Interpharm Press. pp: 185-197.
- Sullivan JD and Watson SW (1975) Purification and properties of the clotting enzyme from Limulus lysate. Biochem. Biophys. Res. Commun. 66, 848-855.
- USP (2009) Bacterial endotoxin test: FDA LAL Test Guideline, 32 (85).
- USP 24-NF (1999) Bacterial Endotoxins Test. 2nd Supplement, 85. The USP Convention, Rockville, MD. pp: 2875-2879.
- Van Noordwijk J and DeJong Y (1977) Comparison of the LAL test with the rabbit test: false positives and false negatives. Dev. Boil. Stand. 34, 39-43.