API impurities and degradants method development and validation in drug development

American Pharmaceutical Outsourcing

Volumn 7, Issue 3, 2006, Pages 28-35

  Natishan, Theresa K ^a  

^a MERCK RESEARCH LABORATORIES   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CYCLODEXTRIN; ERTAPENEM;

ABDOMINAL INFECTION; ANALYTIC METHOD; CAPILLARY ZONE ELECTROPHORESIS; COMMUNITY ACQUIRED PNEUMONIA; DRUG ABSORPTION; DRUG DEGRADATION; DRUG DETERMINATION; DRUG DISTRIBUTION; DRUG EXCRETION; DRUG FORMULATION; DRUG IMPURITY; DRUG INDUSTRY; DRUG MANUFACTURE; DRUG METABOLISM; DRUG SAFETY; DRUG STABILITY; GYNECOLOGIC INFECTION; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HUMAN; LIQUID CHROMATOGRAPHY; MASS SPECTROMETRY; PELVIC INFLAMMATORY DISEASE; PROCESS CONTROL; PROCESS DEVELOPMENT; REVIEW; SKIN INFECTION; URINARY TRACT INFECTION; VALIDATION STUDY;

EID: 55549128594     PISSN: 15296318     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (11)

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2. Yehl, P. et al, Validation of Universal Method for GC Residual Solvents, in press.
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10. Sajonz, P., Natishan, T.K., Wu, Y., Williams, J.M., Pipik, B., DiMichele, L.M., Novak, T., Pitzenberger, S.M., Dubost, D.C., Almarsson, O. J. of Liq. Chrom and Related Tech., 2001, 24(19), 2999-3015.
11. Natishan, T.K., Wu, Y. J. of Chrom. A., 1998, 800, 275-281.