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Introduction to Pharmaceutical Analysis for Drugs

Chuanfeng Zheng

Pharmaceutical analysis is especially focussed in drug analyses, in raw materials and pharmaceutical formulations, involving the determination of active components, impurities, excipients, content uniformity, solubility, dissolution rate and stability.

That process involves several decision points, like the selection of the candidate drug after the invention phase, the appliance to the authorities before testing the compound for the primary time in humans, and eventually the new drug application for marketing, which summarizes the info obtained from all the studies needed for approval of the drug as a drugs. In all these steps the quantity of knowledge generated is gigantic. Analytical chemists are involved in many of the studies that constitute this documentation. Substance quality and its specifications are supported substance analysis, which knowledge is later used for internal control (QC) of the substance during full-scale production.