Analysis of Drug Impurities (Sheffield Analytical Chemistry - download pdf or read online

By Richard J. Smith, Michael L. Webb

ISBN-10: 1405133589

ISBN-13: 9781405133586

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By Richard J. Smith, Michael L. Webb

ISBN-10: 1405133589

ISBN-13: 9781405133586

Show description

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Extra resources for Analysis of Drug Impurities (Sheffield Analytical Chemistry Series)

Sample text

The degradation of cefalcor in solution is initiated by hydrolysis of the ␤-lactam ring followed by internal rearrangements, ring contraction of the six-membered cephem ring system to the five-membered thiazol derivatives via an episulphonium ion intermediate and attack of the phenyglycine primary amine to form substituted pyrazines. In all, a total of more than a dozen degradation products via several different degradation pathways were observed. In contrast, in the solid state, hydrolysis of the ␤-lactam ring is a minor degradation pathway.

0005 Source: Derived from [99]. Note: PVC, Polyvinylchloride; PET, polyethyleneteraphthalate; HDPE, high density polyethylene. ORGANIC IMPURITIES IN DRUG PRODUCTS 41 The choice of packing material is decided by several variables: degree of protection required by the product, cost, marketing preferences and regulatory considerations. Lusina et al. [100] reporting on the packaging optimisation trials they performed on a losartan/hydrochlorothiazide combination tablet. The level of moisture protection could only be evaluated by comparative testing under realistic storage conditions.

In contrast, in the solid state the pH of the micro-environment appears not to be significant. Aman and Thoma [38] showed that the photostability of molsidomine tablets manufactured using differing lubricants with different acidities or basicities was essentially the same. They utilised stearic acid, glycerylpalmitostearate and magnesium stearate to represent acidic, neutral or basic lubricants. In all cases, the photodegradation was similar, and marked, with drug losses between 35% and 40% after 12 h irradiation.

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Analysis of Drug Impurities (Sheffield Analytical Chemistry Series) by Richard J. Smith, Michael L. Webb


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