Overview of USP-NF Requirements for Stability Purposes


This chapter discusses how companies can apply compendial procedures to monitor the stability of their product through product expiry. When companies are able to employ compendial procedures for stability monitoring purposes they may save time and money because they will not need to validate new procedures. In addition, the drug approval process may be quickened by referencing methods already approved and familiar to the regulatory authorities.


Drug Substance Solid Oral Dosage Form Injectable Product Drug Approval Process General Chapter 
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Copyright information

© Springer Science+Business Media, LLC 2009

Authors and Affiliations

  1. 1.Schniepp and Associates, LLCNorthern IllinoisUSA

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