title: Analytical advances in pharmaceutical impurity profiling.
abstract: Impurities will be present in all drug substances and drug products, i.e. nothing is 100% pure if one looks in enough depth. The current regulatory guidance on impurities accepts this, and for drug products with a dose of less than 2g/day identification of impurities is set at 0.1% levels and above (ICH Q3B(R2), 2006). For some impurities, this is a simple undertaking as generally available analytical techniques can address the prevailing analytical challenges; whereas, for others this may be much more challenging requiring more sophisticated analytical approaches. The present review provides an insight into current development of analytical techniques to investigate and quantify impurities in drug substances and drug products providing discussion of progress particular within the field of chromatography to ensure separation of and quantification of those related impurities. Further, a section is devoted to the identification of classical impurities, but in addition, inorganic (metal residues) and solid state impurities are also discussed. Risk control strategies for pharmaceutical impurities aligned with several of the ICH guidelines, are also discussed.
authors.affiliation: H.Lundbeck A/S, Biologics and Pharmaceutical Science, Ottiliavej 9, 2500 Valby, Denmark. Electronic address: RHOL@Lundbeck.com.
authors.forename: René
authors.initials: R
authors.lastname: Holm
authors.affiliation: GlaxoSmithKline, Park Road, Ware, Hertfordshire, SG12 0DP, United Kingdom.
authors.forename: David P
authors.initials: DP
authors.lastname: Elder
mesh_terms: D002623:Chemistry Techniques, Analytical / Q000379:methods; D002626:Chemistry, Pharmaceutical; D004340:Drug Contamination / Q000517:prevention & control*; D013678:Technology, Pharmaceutical / Q000379:methods*
keywords: Analytical techniques; Drug product; Drug substance; ICH Q3; Impurities