By Richard J. Smith, Michael L. Webb
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Extra resources for Analysis of Drug Impurities (Sheffield Analytical Chemistry Series)
9 Use of capillary electrophoresis for the analysis of amoxicillin from four suppliers (a–d). Reprinted from , copyright 1994, with permission from Elsevier. (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 .
Synthetic impurities per se are covered by separate guidelines, ICH Q3A (R) . The amounts of impurities that are allowable are based on the total daily intake of the drug product. There are separate limits (or thresholds) for reporting, identiﬁcation and qualiﬁcation of drug product impurities, sometimes referred to as degradants or degradation products. The reporting threshold is deﬁned as the level that must be reported to regulatory agencies to alert them to the presence of a speciﬁed impurity.
Desiccants have been utilised to control the exposure of products to the ingress of moisture. Desiccants vary in their capacity and the rate that they adsorb/absorb ingressed moisture. Silica gel is very efﬁcient at absorbing moisture at high relative humidities, but comparatively poor at lower relative humidities, whereas for molecular sieve desiccants the opposite scenario prevails. As a consequence, more molecular sieve is required at higher relative humidities, and the greater the handling precautions that are required during packaging operations.
Analysis of Drug Impurities (Sheffield Analytical Chemistry Series) by Richard J. Smith, Michael L. Webb