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By Richard J. Smith, Michael L. Webb

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Louis Mallard reported in 1912 that some amines react with reducing carbohydrates to produce brown pigments. The condensation typically yields a simple glycosylamine, which then readily undergoes the Amadori rearrangement to produce 1-amino-1-deoxy-2-ketoses [95]. Reducing carbohydrates ORGANIC IMPURITIES IN DRUG PRODUCTS 39 such as glucose, maltose, lactose and their derivatives are substrates for this reaction as they can tautomerise to produce the reactive aldehydic form. In contrast, non-reducing carbohydrates such as sucrose, mannitol and trehalose are not reactive.

Flutamide, a non-steriodal anti-androgen, is an acetanilide derivative and undergoes both acid- and base-catalysed amide hydrolysis [51], at the extremes of pH to form 4-nitro-3-trifluoromethylaniline (NTMA). Solutions of flutamide stored at pH 1 for 2 weeks at 45ЊC gave 39% of NTMA, whereas solutions at pH 10 gave 21% of NTMA under the same storage conditions. 4% NTMA). The novel oral cephalosporin, cefalcor, is administered as both oral solutions and solidoral dosage forms. The stability of this product under aqueous acidic and solid-state conditions was described by Baertschi et al.

AMOX is amoxicillin, AMP is ampicillin, PENV is penicillin V, DG is a degradant, and 1 and 2 are unspecified impurities. d. ) peak areas [19]. 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 [20]. Detector sensitivity, especially UV detectors, can vary over an order of magnitude with the model, manufacturer, and age of the source.

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