Analysis of Drug Impurities (Sheffield Analytical Chemistry by Richard J. Smith, Michael L. Webb

By Richard J. Smith, Michael L. Webb

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2001, 24, 785–799. 18. C. L. Flurer and K. A. Wolnik, J. Chromatogr. A, 1994, 674, 153–163. 19. FDA/CDER Reviewer Guidance: Validation of Chromatographic Methods, November 1994, p. htm). 20. FDA/CDER Reviewer Guidance: Validation of Chromatographic Methods, November 1994, p. htm). Analysis of Drug Impurities Edited by Richard J. Smith, Michael L. Webb Copyright © 2007 Blackwell Publishing 2 Organic impurities in drug products: origin, control and measurement David P. 1 Introduction Drug products contain both drug substance (sometimes referred to as the Active Pharmaceutical Ingredient [API]) and excipients.

19. FDA/CDER Reviewer Guidance: Validation of Chromatographic Methods, November 1994, p. htm). 20. FDA/CDER Reviewer Guidance: Validation of Chromatographic Methods, November 1994, p. htm). Analysis of Drug Impurities Edited by Richard J. Smith, Michael L. Webb Copyright © 2007 Blackwell Publishing 2 Organic impurities in drug products: origin, control and measurement David P. 1 Introduction Drug products contain both drug substance (sometimes referred to as the Active Pharmaceutical Ingredient [API]) and excipients.

The results demonstrated qualitative differences in the level of photostabilisation based on the grade of titanium dioxide utilised. Surface-coated particles were shown to induce greater photostabilisation than pharmaceutical grades of the excipient. The authors showed clear superiority of the opacified topical formulation containing 4% titanium dioxide versus the standard clear gel. An elegant publication from Aman and Thoma [84] outlined the various options open to the stabilisation of photolabile oral products.

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