Strategy for identification of leachables in packaged pharmaceutical liquid formulations

Journal of Pharmaceutical and Biomedical Analysis

Volumn 46, Issue 3, 2008, Pages 520-527

  Pan, Changkang ^a   Harmon, Ferris ^a   Toscano, Karen ^a   Liu, Frances ^a   Vivilecchia, Richard ^a  

^a NOVARTIS PHARMA AG   (Switzerland)

Author keywords

Extraction; GC MS; LC MS MS; Leachable identification

Indexed keywords

AGENTS ACTING ON THE EYE; MEPHENESIN;

ARTICLE; DRUG DEGRADATION; DRUG FORMULATION; DRUG ISOLATION; DRUG STABILITY; DRUG STORAGE; DRUG STRUCTURE; ELECTROSPRAY MASS SPECTROMETRY; GAS CHROMATOGRAPHY; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; LEACHING; LIQUID CHROMATOGRAPHY; MASS SPECTROMETRY; PRIORITY JOURNAL; PROTON TRANSPORT;

CHEMISTRY, PHARMACEUTICAL; CHROMATOGRAPHY, HIGH PRESSURE LIQUID; DRUG CONTAMINATION; DRUG PACKAGING; GAS CHROMATOGRAPHY-MASS SPECTROMETRY; SOLUTIONS; SPECTROMETRY, MASS, ELECTROSPRAY IONIZATION;

EID: 37749050318     PISSN: 07317085     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jpba.2007.11.032     Document Type: Article

References (10)

1. Sudhakar P., Nirmala M., Moses Babu J., Vyas K., Reddy G.M., Vijaya Bhaskar B., Pratap Reddy P., and Mukkanti K. J. Pharm. Biomed. Anal. 40 (2006) 605-613
2. Pan C., Liu F., Ji Q., Wang W., Drinkwater D., and Vivilecchia R. J. Pharm. Biomed. Anal. 40 (2006) 581-590
3. Alsante K., Boutros P., Couturier M.A., Friedmann R.C., Harwood J.W., Horan G.L., Jensen A.J., Liu Q., Lohr L.L., Morris R., Raggon J.W., Reid G.L., Satafianos D.P., Sharp T.R., Tucker J.L., and Wilcox G.W. J. Pharm. Sci. 9 (2004) 2296-2309
4. Alsanta K.M., Hatajik T.D., and Lohr L.L. Am. Pharm. Rev. 4 (2001) 70-78
5. Lohr L.L., Sharp T.R., Alsante K.M., and Hatajik T.D. Am. Pharm. Rev. 4 (2001) 104-113
6. Tiller P.R., El Fallah Z., Wilson V., Huysman J., and Patel D. Rapid Commun. Mass Spectrom. 11 (1997) 1570-1574
7. Reepmeyer J.C., and Juhl Y.H. J. Pharm. Sci. 72 (1983) 1302-1305
8. Salmona G., Assaf A., Gayte-Sorbier A., and Airaudo Ch.B. Biol. Mass Spectrom. 11 (1984) 450-454
9. Guidance for Industry: Container Closure Systems for Packaging Human Drugs and Biologics, 1999.
10. Code of Federal Regulations, Part 211 Subpart E.