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Impurity Profiling in Bulk Pharmaceutical Batches Using 19F NMR Spectroscopy and Distinction Between Monomeric and Dimeric Impurities by NMR-based Diffusion Measurements

Impurity Profiling in Bulk Pharmaceutical Batches Using 19F NMR Spectroscopy and Distinction Between Monomeric and Dimeric Impurities by NMR-based Diffusion Measurements

N Mistry, I M Ismail, R D Farrant, M Liu, J K Nicholson, J C Lindon

J Pharm Biomed Anal. 1999 Mar;19(3-4):511-7.

PMID: 10704117

Abstract:

The impurity profile of production batches of fluorine-containing drugs can be characterised efficiently using 19F NMR spectroscopy. This yields the number and proportions of impurities in the bulk drug to a level of approximately equal 0.1 mole% in a few minutes of NMR experiment time. The approach has been exemplified using a partially purified batch of the steroidal product fluticasone propionate, the impurities in which include a number of dimeric species. Further distinction between the monomer and dimer impurities has been achieved through high resolution chemical shift-resolved NMR measurement of molecular diffusion coefficients on the intact mixture using 19F NMR spectroscopy. The ability of NMR-based diffusion coefficient determination to distinguish between monomeric and dimeric substances was validated using a standard mixture of authentic materials containing both monomers and dimers.

Chemicals Related in the Paper:

Catalog Number	Product Name	Structure	CAS Number	Price
CS31041668	Fluticasone Propionate Resolution Mixture			Price

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