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Tadalafil: A Case Study for the Development of Stable Solution Reference Standards for Pharmaceutical Applications

Authors: Matthew Borer, Michael Julius, David Lytle, Tamara Tarbox, Isil Dilek, Uma Sreenivasan, Mitzi Rettinger
Presented at 11th International Symposium on Pharmaceutical Reference Standards, Strasbourg, France, September 2012

Abstract
Reference Standards are a critical part of the control strategy to ensure the quality, safety, and efficacy of pharmaceuticals. Routine QC of pharmaceuticals requires preparation of working solutions from powder reference material on a routine basis. These solutions are typically prepared in volumetric flasks and stored for short intervals in the laboratory. Weighing of materials for standards in the lab can be time consuming, especially when materials are hygroscopic, toxic, or controlled. One source of lot-to-lot discrepancies in release testing is variation in the reference standard working solution which can result from weighing and dilution differences between batches. A solution-based reference standard packaged in a format that preserves concentration and integrity of the material provides a convenient, consistent and cost-effective alternative to preparation of working reference standard solutions in the analytical lab.


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