In vitro genotoxicity of piperacillin impurity-A

African Journal of Biotechnology

Volumn 6, Issue 18, 2007, Pages 2074-2077

  Vijayan, Magesh ^a   Deecaraman, M ^a   Pudupalayam, Kalaichelvan Thangavelu ^b  

^a DR M G R EDUCATIONAL AND RESEARCH INSTITUTE   (India)

^b UNIVERSITY OF MADRAS   (India)

Author keywords

Chromosomal aberration study; Mutagenic activity; Piperacillin impurity A; Salmonella typhimurium

Indexed keywords

PIPERACILLIN;

AMES TEST; ARTICLE; CHEMICAL MUTAGENESIS; CHEMICAL STRESS; CHROMOSOME ABERRATION; CONTROLLED STUDY; DRUG CONTAMINATION; DRUG IMPURITY; DRUG MANUFACTURE; GENOTOXICITY; IN VITRO STUDY; MUTAGENICITY; NONHUMAN; SALMONELLA TYPHIMURIUM;

BACTERIA (MICROORGANISMS); SALMONELLA TYPHIMURIUM;

EID: 34848914464     PISSN: None     EISSN: 16845315     Source Type: Journal    
DOI: 10.5897/ajb2007.000-2320     Document Type: Article

References (9)

1. AHFS Drug Information (2002). Bethesda, MD: American Society of Health Systems Pharmasits.
2. ANDAs Impurities in Drug Products (1998). Guidance for Industry, Food and Drug Administration. U.S. Department of Health and Human Services, Center Drug Eval. Res. (CDER). pp. 1-14.
3. Impurities in Drug Substances...ANDAs (2000). Int. J. Gen. Drugs. 3(8): 365-379.
4. International Conference on Harmonisation (ICH) (2000a). Draft revised Guidance on Impurities in New Drug products. 65(139): 44791-44797.
5. International Conference on Harmonisation (ICH) (2000b). Guidance on Q6A Specification: Test procedures and acceptance criteria for new drug substances and new drug products: Chemical Substance. Federal Register. 65(251): 83041-61.
6. Maron DM, Ames BM (1983). Revised methods for the Salmonella mutagenicity test. Mutat. Res. 113 : 173-215.
7. OECD Guidelines for Testing of Chemicals (1987). Number 401. Pharmeuropa (2002). 14(3): 422-424.
8. U.S Environmental Protection Agency (1998). Health Effects Test Guidelines OPPTS 870.5375 EPA 712-C-98-223.
9. Venitt S, Crofton-Sleigh C, Forster R (1990). Assay for the Detection of Chemically -Induced Chromosome Damage in Cultured Mammalian Cells, In: Mutagenicity Testing - Practical Approach, Venitt S, Parry JM [eds], pp. 187-232.