Active drug substance impurity profiling. Part I. LC/UV diode array spectral matching

Journal of Pharmaceutical and Biomedical Analysis

Volumn 16, Issue 5, 1998, Pages 813-824

  Nicolas, Edgar C ^a   Scholz, Thomas H ^a  

^a DUPONT COMPANY   (United States)

Author keywords

Diode array spectra; HPLC; Impurity profiling; Spectral matching

Indexed keywords

ANTINEOPLASTIC AGENT; LOSOXANTRONE;

ARTICLE; DIODE; DRUG IMPURITY; FACTORIAL ANALYSIS; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; PRIORITY JOURNAL; SPECTROSCOPY; ULTRAVIOLET SPECTROSCOPY;

ANTHRAQUINONES; ANTINEOPLASTIC AGENTS; CHROMATOGRAPHY, HIGH PRESSURE LIQUID; DRUG CONTAMINATION; PYRAZOLES; PYRAZOLONES; SENSITIVITY AND SPECIFICITY; SPECTROPHOTOMETRY, ULTRAVIOLET;

EID: 0031906912     PISSN: 07317085     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0731-7085(97)00131-3     Document Type: Article

References (10)

1. International Conference on Harmonization Quality Guideline III/5442/94-EN, Impurities in New Drug Substances, in: The Federal Register 61 (1996) 372-374.
2. Giron D. Boll. Chim. Farm. 133:1994;201-220.
3. Alfredson T., Sheehan T. J. Chromatogr. Sci. 24:1986;473-482.
4. Hill D.W., Kelley T.R., Langner K.J. Anal. Chem. 59:1987;350-353.
5. Demorest D.M., Fetzer J.C., Lurie I.S., Carr S.M., Chatson K.B. LC-GC. 5:1987;128-142.
6. R.W. Giuffre, in: L. Huber, S. George (Eds.), Diode Array Detectors in HPLC, Marcel Dekker, New York, 1993, pp. 163-197.
7. H.J.P. Sievert, A.C.J.H. Drouen, in; L. Huber, S. George (Eds.), Diode Array Detectors in HPLC, Marcel Dekker, New York 1993, pp. 51-126.
8. Cavina G., Valvo L., Galinella B., Porra R., Savella A.L. J. Pharm. Biomed. Anal. 10:1992;437-446.
9. Cavina G., Alimenti R., Galinella B., Valvo L. J. Pharm. Biomed. Anal. 10:1992;685-692.
10. E.C. Nicolas, T.H. Scholz, J. Pharm. Biomed. Anal., in press.