Parenteral Product Specifications and Stability
2019
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.
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