By Richard J. Smith, Michael L. Webb
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Extra info for Analysis of Drug Impurities (Sheffield Analytical Chemistry Series)
Hoogmartens, Chromatographia, 1991, 32, 162–166. 12. R. Grahek, D. Milivojevic, A. Bastarda and M. Kracun, J. Chromatogr. A, 2001, 918, 319–324. 13. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, ICH Q7A: Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients, 2000. 14. G. Xue, A. D. Bendick, R. Chen and S. S. Sekulic, J. Chromatogr. A, 2004, 1050, 159–171. 15. R. Otero, G. Carrera, J. F. Dulsat, J. L. Fábregas and J.
AMOX is amoxicillin, AMP is ampicillin, PENV is penicillin V, DG is a degradant, and 1 and 2 are unspeciﬁed impurities. d. ) peak areas . A calibration standard containing either an impurity or drug substance at the limit of quantitation will be a useful tool to ensure that impurities may be quantitatively determined down to the level of the quantitation limit at the time of analysis . Detector sensitivity, especially UV detectors, can vary over an order of magnitude with the model, manufacturer, and age of the source.
4%). 5%). 4%) was in accord with recommended criteria . 0%. 999. 185 μg/ml (ca. 04%). A major consequence of using regulatory limits based on degradant formation, rather than absolute change of the API level in the drug product, is that it necessitates the application and routine use of very sensitive analytical techniques . In addition, the need to resolve both structurally similar, as well as structurally diverse degradants of the API, mandates the use of analytical separation techniques, for example, HPLC, CE, often coupled with highly sensitive detection modes, for example, ultraviolet (UV) spectroscopy, ﬂuorescence (F) spectroscopy, electrochemical detection (EC), mass spectroscopy (MS), tandem mass spectroscopy (MS-MS) and so forth.
Analysis of Drug Impurities (Sheffield Analytical Chemistry Series) by Richard J. Smith, Michael L. Webb