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posted May 07 '10 at 05:47

sekhar%20Talluri's gravatar image

sekhar Talluri
621

The following reference might be relevant. Analytical techniques for biopharmaceutical development (pages 311-318) By Roberto Rodríguez-Díaz, Tim Wehr, Stephen F. Tuck Publisher CRC Press, 2005 ISBN 0824707060, 9780824707064
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posted May 07 '10 at 06:06

sekhar%20Talluri's gravatar image

sekhar Talluri
621

The following reference might be relevant.

Analytical techniques for biopharmaceutical development (pages 311-318) By Roberto Rodríguez-Díaz, Tim Wehr, Stephen F. Tuck Publisher CRC Press, 2005 ISBN 0824707060, 9780824707064

They write "...Detecting a low level-level (<10ug/ml) small molecule impurity in the presence of active protein and excipients at much higher concentrations is a daunting analytical problem. In many cases, NMR is an excellent method for solving such challenging analytical problems..."

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No.2 Revision

posted May 23 '10 at 11:41

sekhar%20Talluri's gravatar image

sekhar Talluri
621

The following reference references might be relevant.

  1. Separation and Analysis of Trace Degradants in a Pharmaceutical Formulation Using On-Line Capillary Isotachophoresis-NMR. Stacie L. Eldridge, Valentino K. Almeida, Albert K. Korir, and Cynthia K. Larive. Anal. Chem., 2007, 79 (22), pp 8446–8453

  2. NMR spectroscopy in pharmaceutical analysis. By Iwona Wawer, Ulrike Holzgrabe, Bernd Diehl ...discuss possibilities for use of NMR for detection of impurities in pharmaceuticals.

  3. Analytical techniques for biopharmaceutical development (pages 311-318) By Roberto Rodríguez-Díaz, Tim Wehr, Stephen F. Tuck Publisher CRC Press, 2005 ISBN 0824707060, 9780824707064

They write "...Detecting a low level-level (<10ug/ml) small molecule impurity in the presence of active protein and excipients at much higher concentrations is a daunting analytical problem. In many cases, NMR is an excellent method for solving such challenging analytical problems..."

click to hide/show revision 4
No.3 Revision

posted May 23 '10 at 11:49

sekhar%20Talluri's gravatar image

sekhar Talluri
621

The following references might be relevant.

  1. Separation and Analysis of Trace Degradants in a Pharmaceutical Formulation Using On-Line Capillary Isotachophoresis-NMR. Stacie L. Eldridge, Valentino K. Almeida, Albert K. Korir, and Cynthia K. Larive. Anal. Chem., 2007, 79 (22), pp 8446–8453

  2. NMR spectroscopy in pharmaceutical analysis. By Iwona Wawer, Ulrike Holzgrabe, Bernd Diehl ...discuss possibilities for use of NMR for detection of impurities in pharmaceuticals.

  3. Analytical techniques for biopharmaceutical development (pages 311-318) By Roberto Rodríguez-Díaz, Tim Wehr, Stephen F. Tuck Publisher CRC Press, 2005 ISBN 0824707060, 9780824707064

They write "...Detecting a low level-level (<10ug/ml) small molecule impurity in the presence of active protein and excipients at much higher concentrations is a daunting analytical problem. In many cases, NMR is an excellent method for solving such challenging analytical problems..."

I do agree with Kirk Marat that, in most cases, other techniques would be preferable.
However, for specific cases, such as those discussed above, NMR may have some advantages.

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