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An Overview of Physical Stability of Pharmaceuticals

  • Yushen Guo
Chapter
Part of the Biotechnology: Pharmaceutical Aspects book series (PHARMASP, volume XII)

Abstract

From drug discovery and development to regulatory approval and marketing, the acceptable stability of the drug substance and drug product is one of the basic quality requirements. The overall stability of a drug product is related not only to the intrinsic chemical stability of the drug molecule, but also the physical form, manufacturing process, interactions among formulation components, package, and storage condition. In this paper, the major physical stability attributes of pharmaceuticals are discussed.

Keywords

Dosage Form Drug Product Cocoa Butter Drug Substance Physical Stability 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

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Copyright information

© American Association of Pharmaceutical Scientists 2010

Authors and Affiliations

  1. 1.Achaogen Inc.South San FranciscoUSA

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