Pharmaceutical Technology Europe, December 1st, 2004
Familiarity with the scientific and technical literature regarding the specifications of chemical substances for pharmaceutical use is of primary importance, particularly for those working in QA/QC, production and formulation development. In this article, adopted technical guidelines, relevant pharmacopoeial general monographs and chapters as well as regulatory mandates on this topic are reviewed.
A substance is any matter that may be of human, animal, vegetable (plant) or chemical origin. Substances intended for pharmaceutical purposes are used as active ingredients (drug substances) or exci...
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