Parenteral Product Specifications and Stability

INTRODUCTION Specifications and stability of parenteral products are set in the broader context of drug product development of small molecules, biologics, and devices. The specifications for a finished pharmaceutical product are an accepted list of requirements that a product must meet before it is released into distribution. Typically, these requirements are laboratory tests and associated acceptance criteria. International Conference on Harmonisation (ICH) Q6A (1) provides a suitable working definition of specifications. For purposes of this chapter, the definition should be broadened to extend beyond “new” drug substances and products.