Impurity profiling in bulk pharmaceutical batches using 19F NMR spectroscopy and distinction between monomeric and dimeric impurities by NMR-based diffusion measurements

Author:

Mistry Nisha,Ismail Ismail M.,Duncan Farrant R.,Liu Maili,Nicholson Jeremy K.,Lindon John C.

Publisher

Elsevier BV

Subject

Clinical Biochemistry,Spectroscopy,Drug Discovery,Pharmaceutical Science,Analytical Chemistry

Reference12 articles.

1. International Federal Pharmaceutical Manufacturing Association, Guideline: test procedures and acceptance criteria for new drug substances and new drug products; chemical substances, in: International Conference on Harmonisation, Geneva, Switzerland, July 1997.

2. Characterisation of impurities in bulk drug batches of fluticasone propionate using directly coupled HPLC–NMR spectroscopy and HPLC–MS

3. J.C. Lindon, in: A. Townshend (Ed.), Encyclopedia of Analytical Science, Academic Press, London, 1995, pp 3408–3411.

4. High-Resolution Diffusion-Ordered 2D Spectroscopy (HR-DOSY) - A New Tool for the Analysis of Complex Mixtures

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