Research ArticleTechnology/Application
Automated Solid Phase Extraction (SPE) LC/NMR Applied to the Structural Analysis of Extractable Compounds from a Pharmaceutical Packaging Material of Construction
Daniel L. Norwood, James O. Mullis, Mark Davis, Scott Pennino, Thomas Egert and Nina C. Gonnella
PDA Journal of Pharmaceutical Science and Technology May 2013, 67 (3) 267-287; DOI: https://doi.org/10.5731/pdajpst.2013.00920
Daniel L. Norwood
Boehringer Ingelheim Pharmaceuticals, Inc.
James O. Mullis
Boehringer Ingelheim Pharmaceuticals, Inc.
Mark Davis
Boehringer Ingelheim Pharmaceuticals, Inc.
Scott Pennino
Boehringer Ingelheim Pharmaceuticals, Inc.
Thomas Egert
Boehringer Ingelheim Pharmaceuticals, Inc.
Nina C. Gonnella
Boehringer Ingelheim Pharmaceuticals, Inc.

References
- 1.↵
U.S Department of Health and Human Services, FDA, Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research. Guidance for Industry—Container Closure Systems for Packaging Human Drugs and Biologics; FDA: Silver Spring, MD, 1999.
- 2.↵
PQRI Leachables and Extractables Working Group. Safety Thresholds and Best Practices for Extractables and Leachables in Orally Inhaled and Nasal Drug Products; PQRI: Arlington, VA, 2006.
- 3.↵
- Ball D. ,
- Blanchard J. ,
- Jacobson-Kram D. ,
- McClellan R. ,
- McGovern T. ,
- Norwood D. L. ,
- Vogel M. ,
- Wolff R. ,
- Nagao L.
- 4.↵
- Norwood D. L. ,
- Paskiet D. ,
- Ruberto M. ,
- Feinberg T. ,
- Schroeder A. ,
- Poochikian G. ,
- Wang Q. ,
- Deng T. J. ,
- DeGrazio F. ,
- Munos M. K. ,
- Nagao L. M.
- 5.↵
PQRI. Parenteral and Ophthalmics Drug Product (PODP) Working Group. PQRI Workshop on Safety Thresholds and Best Practices for Parenteral and Ophthalmic Drug Products, Bethesda, MD, February 22 and 23, 2011.
- 6.↵
- Ball D. L. ,
- Norwood D. L. ,
- Stults C. L. M. ,
- Nagao L. M.
- Feilden A. D. ,
- Rignall A.
- 7.↵
- Ball D. L. ,
- Norwood D. L. ,
- Stults C. L. M. ,
- Nagao L. M.
- Feinberg T. ,
- Norwood D. ,
- Granger A. ,
- Jenke D.
- 8.↵
- Ball D. L. ,
- Norwood D. L. ,
- Stults C. L. M. ,
- Nagao L. M.
- Norwood D. ,
- Qiu F. ,
- Coleman J. ,
- Mullis J. ,
- Granger A. ,
- McKellop K. ,
- Raiker M. ,
- Robson J.
- 9.↵
- Ball D. L. ,
- Norwood D. L. ,
- Stults C. L. M. ,
- Nagao L. M.
- Paskiet D. ,
- Stubbs L. ,
- Hendriker A.
- 10.↵
- Ball D. L. ,
- Norwood D. L. ,
- Stults C. L. M. ,
- Nagao L. M.
- Norwood D. L. ,
- Feinberg T. N. ,
- Mullis J. O. ,
- Pennino S. J.
- 11.↵
- Norwood D. L. ,
- Jenke D. ,
- Manolescu C. ,
- Pennino S. ,
- Grinberg N.
- 12.↵
- Ahuja S. ,
- Rasmussen H.
- Norwood D. L. ,
- Mullis J. O. ,
- Feinberg T. N.
- 13.↵
- Swarbrick J.
- Norwood D. L. ,
- Granger A. T. ,
- Paskiet D. M.
- 14.↵
- Ball D. L. ,
- Norwood D. L. ,
- Stults C. L. M. ,
- Nagao L. M.
- Ruberto M. A. ,
- Paskiet D. ,
- Miller K.
- 15.↵
- Rabek J.
- 16.↵
- Morton M.
- 17.↵
- Jenke D.
- 18.↵
- Pennino S. ,
- Norwood D. L.
- 19.↵
- Norwood D. L. ,
- Mullis J. O. ,
- Davis M. ,
- Egert T. ,
- Gonnella N. C.
- 20.↵
- 21.↵
- Bax A. ,
- Davis D. G.
- 22.↵
- Bax A. ,
- Davis D. G.
- 23.↵
- Bodenhausen G. ,
- Ruben D. J.
- 24.↵
- Bax A. ,
- Summers M. F.
- 25.↵
- Shi Z. M.
- 26.↵
- Shi Z. M. ,
- Oya T.
- 27.↵
- Pospíšil J.
In This Issue
PDA Journal of Pharmaceutical Science and Technology
Vol. 67, Issue 3
May/June 2013
Automated Solid Phase Extraction (SPE) LC/NMR Applied to the Structural Analysis of Extractable Compounds from a Pharmaceutical Packaging Material of Construction
Daniel L. Norwood, James O. Mullis, Mark Davis, Scott Pennino, Thomas Egert, Nina C. Gonnella
PDA Journal of Pharmaceutical Science and Technology May 2013, 67 (3) 267-287; DOI: 10.5731/pdajpst.2013.00920
Automated Solid Phase Extraction (SPE) LC/NMR Applied to the Structural Analysis of Extractable Compounds from a Pharmaceutical Packaging Material of Construction
Daniel L. Norwood, James O. Mullis, Mark Davis, Scott Pennino, Thomas Egert, Nina C. Gonnella
PDA Journal of Pharmaceutical Science and Technology May 2013, 67 (3) 267-287; DOI: 10.5731/pdajpst.2013.00920
Jump to section
Related Articles
- No related articles found.