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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Huang et al. [59] evaluated some common excipients for residual levels of hydrogen peroxide. They found levels of H2O2 in the range 0–244 ppm, but perhaps of more concern, they showed quite pronounced differences between different batches of the same vendor and between different vendors of the same excipient. For example, although there is some variability of residual peroxide levels in PEG 400 (polyethylene glycol) from vendor B (5–16 ppm), the differences were small, in contrast with those seen from vendor C (2–59 ppm).

Otero, G. Carrera, J. F. Dulsat, J. L. Fábregas and J. Claramunt, J. Chromatogr. A, 2004, 1057, 193–201. 20 ANALYSIS OF DRUG IMPURITIES 16. K. J. Mulligan, T. W. Brueggemeyer, D. F. Crockett and J. B. Schepman, J. Chromatogr. B, 1996, 686, 85–95. 17. S. Zaugg and W. Thormann, J. Pharm. Biomed. , 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.

The resultant biological, chemical and physical properties of the drug product are directly dependent on the excipients chosen, their concentration and interactions with the API [1]. Excipients are sub-divided into various functional classifications, depending on the role that they are intended to play in the resultant formulation, for example, fillers, disintegrants, binders, lubricants and glidants. An added complexity is the fact that certain excipients can have different functional roles in different formulation types.

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